Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-03-01 @ 3:52 PM
Study NCT ID:
NCT01999920
Status:
COMPLETED
Last Update Posted:
2018-03-07
First Post:
2013-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vilazodone for Separation Anxiety Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001010', 'term': 'Anxiety, Separation'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069503', 'term': 'Vilazodone Hydrochloride'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D007211', 'term': 'Indoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'fschneier@nyspi.columbia.edu', 'phone': '6464774-8041', 'title': 'Franklin Schneier, MD', 'organization': 'NYSPI'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Baseline to week 12', 'eventGroups': [{'id': 'EG000', 'title': 'Vilazodone', 'description': 'Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.\n\nVilazodone: 10mg to 40mg per day for 12 weeks', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 13, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Pill placebo.\n\nPlacebo: One to two pills per day for 12 weeks', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea/Gas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Excessive Sweating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Problems', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruising Easily', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Impaired Coordination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased Libido (men)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased Libido (women)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sexual Dysfunction (men)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sexual Dysfunction (women)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurry Vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Forgetfulness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Impaired Concentration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Apathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Global Impression-Improvement Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vilazodone', 'description': 'Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.\n\nVilazodone: 10mg to 40mg per day for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Pill placebo.\n\nPlacebo: One to two pills per day for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.064', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 weeks', 'description': 'Clinical Global Impression-Improvement Scale rating at week 12 A quickly administered and widely used observer rating, with ratings from 1 (very much improved) to 7 (very much worse). "Responder" is a score of 1 or 2.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Hamilton Rating Scale for Depression 17-item Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vilazodone', 'description': 'Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.\n\nVilazodone: 10mg to 40mg per day for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Pill placebo.\n\nPlacebo: One to two pills per day for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '7.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Standard error', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.50', 'ciLowerLimit': '-1.32', 'ciUpperLimit': '12.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.13', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 12 weeks', 'description': 'This standard scale will be used to assess severity of depression, looking at change in total score from baseline to week 12, rating severity of depression on a scale from 0 (least depression) to 50 (greatest depression).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Attachment Style Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vilazodone', 'description': 'Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.\n\nVilazodone: 10mg to 40mg per day for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Pill placebo.\n\nPlacebo: One to two pills per day for 12 weeks'}], 'classes': [{'title': 'Confidence', 'categories': [{'measurements': [{'value': '32.3', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '26.9', 'spread': '10.3', 'groupId': 'OG001'}]}]}, {'title': 'Discomfort with Closeness', 'categories': [{'measurements': [{'value': '35.6', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '42.3', 'spread': '6.9', 'groupId': 'OG001'}]}]}, {'title': 'Relationships as Secondary', 'categories': [{'measurements': [{'value': '16.3', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '20.7', 'spread': '9.1', 'groupId': 'OG001'}]}]}, {'title': 'Need for Approval', 'categories': [{'measurements': [{'value': '20.6', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '23.6', 'spread': '8.0', 'groupId': 'OG001'}]}]}, {'title': 'Preoccupation with Relationships', 'categories': [{'measurements': [{'value': '30.0', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '32.1', 'spread': '7.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.89', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Standard error', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '-4.85', 'ciUpperLimit': '5.53', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.44', 'groupDescription': 'Confidence variable', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.79', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Standard error', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '-8.21', 'ciUpperLimit': '10.58', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.41', 'groupDescription': 'Discomfort with Closeness variable', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.31', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Standard error', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.94', 'ciLowerLimit': '-4.12', 'ciUpperLimit': '12.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.79', 'groupDescription': 'Relationships as Secondary variable', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Standard error', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.60', 'ciLowerLimit': '-5.79', 'ciUpperLimit': '0.58', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.49', 'groupDescription': 'Need for Approval variable', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.80', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Standard error', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '-5.30', 'ciUpperLimit': '6.72', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.82', 'groupDescription': 'Preoccupation with Relationships variable', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 12 weeks', 'description': 'Measure Description: (15 min) Attachment Style Questionnaire (Feeney at al., 1994) 40 items relating to quality of adult relationships. Questionnaire includes questions concerning Confidence (8 items, minimum score=8, maximum score=48), Discomfort (10 items, minimum score=10, maximum score=60), Relationships as Secondary (7 items, minimum score=7, maximum score=42), Need for Approval (7 items, minimum score=7, maximum score =42), and Preoccupation with Relationships (8 items, minimum score = 8, maximum score=48), each self-rated on a six-point scale, each self-rated from 1 (totally disagree) to 6 (totally agree).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quality of Life Enjoyment & Satisfaction Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vilazodone', 'description': 'Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.\n\nVilazodone: 10mg to 40mg per day for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Pill placebo.\n\nPlacebo: One to two pills per day for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '68.9', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '47.8', 'spread': '31.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Standard error', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.91', 'ciLowerLimit': '-34.23', 'ciUpperLimit': '-5.58', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.99', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 12 weeks', 'description': 'Measure Description: (10 min) Quality of Life Enjoyment \\& Satisfaction Questionnaire (Q-LES-Q, Endicott et al, 1993): self-rated assessment of quality of life. 16 items related to life quality, each rated on a score of 1 (very poor) to 5 (very good), with a minimum total score of 16, and a maximum total score of 80.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on Structured Clinical Interview for Separation Anxiety Disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vilazodone', 'description': 'Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.\n\nVilazodone: 10mg to 40mg per day for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Pill placebo.\n\nPlacebo: One to two pills per day for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '3.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.026', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Standard error', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.29', 'ciLowerLimit': '0.42', 'ciUpperLimit': '6.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.43', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 12', 'description': "The Structured Clinical Interview for Separation Anxiety Disorder was modified for DSM-5. The eight separation anxiety disorder criteria are rated for both childhood (rated at baseline only) and past week time frames, scored as 0 (not at all), 1 (sometimes), 2 (often) or ? (don't recall). In keeping with the DSM-5 guidelines, endorsement of three or more of the eight criterion symptoms (symptoms rated as '2' or 'often') is used as a threshold to determine categorical (yes/no) diagnosis of separation anxiety disorder. Scores on each of the eight items are also summed to produce a continuous measure of separation anxiety symptoms experienced during childhood and adulthood (range for each scale=0-16).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on Adult Separation Anxiety - 27 Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vilazodone', 'description': 'Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.\n\nVilazodone: 10mg to 40mg per day for 12 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Pill placebo.\n\nPlacebo: One to two pills per day for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '14.4', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '40.6', 'spread': '19.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Standard error', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.38', 'ciLowerLimit': '5.64', 'ciUpperLimit': '37.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.65', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 12 weeks', 'description': 'Measure Description: (15 min) Adult Separation Anxiety - 27 Scale 27 items pertaining to adult separation anxiety, each self-rated on a four-point scale, 0=best, 3=worse. Minimum Total Score=0 (better); Maximum Total Score = 81 (worse)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vilazodone', 'description': 'Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.\n\nVilazodone: 10mg to 40mg per day for 12 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Pill placebo.\n\nPlacebo: One to two pills per day for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vilazodone', 'description': 'Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.\n\nVilazodone: 10mg to 40mg per day for 12 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Pill placebo.\n\nPlacebo: One to two pills per day for 12 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.3', 'spread': '14.2', 'groupId': 'BG000'}, {'value': '32.9', 'spread': '15.6', 'groupId': 'BG001'}, {'value': '35.2', 'spread': '14.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hamilton Depression Rating Scale 17-item', 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'spread': '6.3', 'groupId': 'BG000'}, {'value': '9.3', 'spread': '5.0', 'groupId': 'BG001'}, {'value': '10.5', 'spread': '5.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '(10 min) Hamilton Rating Scale for Depression (Hamilton, 1960) This standard scale will be used to assess severity of depression, from 0 (least depression) to 50 (greatest depression', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Attachment Style Questionnaire', 'classes': [{'title': 'Confidence', 'categories': [{'measurements': [{'value': '30.5', 'spread': '5.3', 'groupId': 'BG000'}, {'value': '25.3', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '28.1', 'spread': '7.7', 'groupId': 'BG002'}]}]}, {'title': 'Discomfort with Closeness', 'categories': [{'measurements': [{'value': '38.2', 'spread': '8.9', 'groupId': 'BG000'}, {'value': '46.9', 'spread': '7.7', 'groupId': 'BG001'}, {'value': '42.2', 'spread': '9.3', 'groupId': 'BG002'}]}]}, {'title': 'Relationships as Secondary', 'categories': [{'measurements': [{'value': '17.4', 'spread': '6.0', 'groupId': 'BG000'}, {'value': '19.0', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '18.1', 'spread': '5.9', 'groupId': 'BG002'}]}]}, {'title': 'Need for Approval', 'categories': [{'measurements': [{'value': '23.8', 'spread': '4.6', 'groupId': 'BG000'}, {'value': '26.1', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '24.8', 'spread': '6.8', 'groupId': 'BG002'}]}]}, {'title': 'Preoccupation with Relationships', 'categories': [{'measurements': [{'value': '34.4', 'spread': '5.1', 'groupId': 'BG000'}, {'value': '33.6', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '34.0', 'spread': '5.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '(15 min) Attachment Style Questionnaire (Feeney at al., 1994) 40 items relating to quality of adult relationships. Questionnaire includes questions concerning Confidence (8 items, minimum score=8, maximum score=48), Discomfort (10 items, minimum score=10, maximum score=60), Relationships as Secondary (7 items, minimum score=7, maximum score=42), Need for Approval (7 items, minimum score=7, maximum score =42), and Preoccupation with Relationships (8 items, minimum score = 8, maximum score=48), each self-rated on a six-point scale, each self-rated from 1 (totally disagree) to 6 (totally agree)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Quality of Life Enjoyment & Satisfaction Questionnaire', 'classes': [{'categories': [{'measurements': [{'value': '46.5', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '55.4', 'spread': '22.2', 'groupId': 'BG001'}, {'value': '50.6', 'spread': '17.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '(10 min) Quality of Life Enjoyment \\& Satisfaction Questionnaire (Q-LES-Q, Endicott et al, 1993): self-rated assessment of quality of life. 16 items related to life quality, each rated on a score of 1 (very poor) to 5 (very good), with a minimum total score of 16, and a maximum total score of 80.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Structured Clinical Interview for Separation Anxiety Disorder', 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '10.2', 'spread': '2.5', 'groupId': 'BG001'}, {'value': '10.5', 'spread': '2.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Structured Clinical Interview for Separation Anxiety Disorder modified for DSM-5. The eight separation anxiety disorder criteria are each rated on a 0-2 scale for past week time frame. Scores on each of the eight items are summed to produce a total score (range 0 - 16). A higher total score indicates higher symptoms of separation anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Adult Separation Anxiety - 27 Scale', 'classes': [{'categories': [{'measurements': [{'value': '44.3', 'spread': '15.1', 'groupId': 'BG000'}, {'value': '52.0', 'spread': '13.6', 'groupId': 'BG001'}, {'value': '47.8', 'spread': '14.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '(15 min) Adult Separation Anxiety - 27 Scale 27 items pertaining to adult separation anxiety, each self-rated on a four-point scale, 0=best, 3=worse. Minimum Total Score=0 (better); Maximum Total Score = 81 (worse)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Subjects with adult separation anxiety disorder'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-07', 'size': 141778, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2017-08-04T15:32', 'hasProtocol': False}, {'date': '2016-09-30', 'size': 333735, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2017-10-03T09:20', 'hasProtocol': False}, {'date': '2016-10-07', 'size': 4254718, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2017-10-03T10:10', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-06', 'studyFirstSubmitDate': '2013-11-26', 'resultsFirstSubmitDate': '2017-04-27', 'studyFirstSubmitQcDate': '2013-11-26', 'lastUpdatePostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-03', 'studyFirstPostDateStruct': {'date': '2013-12-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Global Impression-Improvement Scale', 'timeFrame': 'Up to 12 weeks', 'description': 'Clinical Global Impression-Improvement Scale rating at week 12 A quickly administered and widely used observer rating, with ratings from 1 (very much improved) to 7 (very much worse). "Responder" is a score of 1 or 2.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline Hamilton Rating Scale for Depression 17-item Total Score', 'timeFrame': 'Up to 12 weeks', 'description': 'This standard scale will be used to assess severity of depression, looking at change in total score from baseline to week 12, rating severity of depression on a scale from 0 (least depression) to 50 (greatest depression).'}, {'measure': 'Change From Baseline in Attachment Style Questionnaire Score', 'timeFrame': 'Up to 12 weeks', 'description': 'Measure Description: (15 min) Attachment Style Questionnaire (Feeney at al., 1994) 40 items relating to quality of adult relationships. Questionnaire includes questions concerning Confidence (8 items, minimum score=8, maximum score=48), Discomfort (10 items, minimum score=10, maximum score=60), Relationships as Secondary (7 items, minimum score=7, maximum score=42), Need for Approval (7 items, minimum score=7, maximum score =42), and Preoccupation with Relationships (8 items, minimum score = 8, maximum score=48), each self-rated on a six-point scale, each self-rated from 1 (totally disagree) to 6 (totally agree).'}, {'measure': 'Change From Baseline in Quality of Life Enjoyment & Satisfaction Questionnaire', 'timeFrame': 'Up to 12 weeks', 'description': 'Measure Description: (10 min) Quality of Life Enjoyment \\& Satisfaction Questionnaire (Q-LES-Q, Endicott et al, 1993): self-rated assessment of quality of life. 16 items related to life quality, each rated on a score of 1 (very poor) to 5 (very good), with a minimum total score of 16, and a maximum total score of 80.'}, {'measure': 'Change From Baseline on Structured Clinical Interview for Separation Anxiety Disorder', 'timeFrame': 'Baseline and week 12', 'description': "The Structured Clinical Interview for Separation Anxiety Disorder was modified for DSM-5. The eight separation anxiety disorder criteria are rated for both childhood (rated at baseline only) and past week time frames, scored as 0 (not at all), 1 (sometimes), 2 (often) or ? (don't recall). In keeping with the DSM-5 guidelines, endorsement of three or more of the eight criterion symptoms (symptoms rated as '2' or 'often') is used as a threshold to determine categorical (yes/no) diagnosis of separation anxiety disorder. Scores on each of the eight items are also summed to produce a continuous measure of separation anxiety symptoms experienced during childhood and adulthood (range for each scale=0-16)."}, {'measure': 'Change From Baseline on Adult Separation Anxiety - 27 Scale', 'timeFrame': 'Up to 12 weeks', 'description': 'Measure Description: (15 min) Adult Separation Anxiety - 27 Scale 27 items pertaining to adult separation anxiety, each self-rated on a four-point scale, 0=best, 3=worse. Minimum Total Score=0 (better); Maximum Total Score = 81 (worse)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adult separation anxiety disorder', 'ASAD'], 'conditions': ['Separation Anxiety Disorder']}, 'referencesModule': {'references': [{'pmid': '16741209', 'type': 'BACKGROUND', 'citation': 'Shear K, Jin R, Ruscio AM, Walters EE, Kessler RC. Prevalence and correlates of estimated DSM-IV child and adult separation anxiety disorder in the National Comorbidity Survey Replication. Am J Psychiatry. 2006 Jun;163(6):1074-83. doi: 10.1176/ajp.2006.163.6.1074.'}, {'pmid': '1771219', 'type': 'BACKGROUND', 'citation': 'Winslow JT, Insel TR. Serotonergic modulation of the rat pup ultrasonic isolation call: studies with 5HT1 and 5HT2 subtype-selective agonists and antagonists. Psychopharmacology (Berl). 1991;105(4):513-20. doi: 10.1007/BF02244372.'}, {'pmid': '17447222', 'type': 'BACKGROUND', 'citation': 'Simpson BS, Landsberg GM, Reisner IR, Ciribassi JJ, Horwitz D, Houpt KA, Kroll TL, Luescher A, Moffat KS, Douglass G, Robertson-Plouch C, Veenhuizen MF, Zimmerman A, Clark TP. Effects of reconcile (fluoxetine) chewable tablets plus behavior management for canine separation anxiety. Vet Ther. 2007 Spring;8(1):18-31.'}, {'pmid': '18974308', 'type': 'BACKGROUND', 'citation': 'Walkup JT, Albano AM, Piacentini J, Birmaher B, Compton SN, Sherrill JT, Ginsburg GS, Rynn MA, McCracken J, Waslick B, Iyengar S, March JS, Kendall PC. Cognitive behavioral therapy, sertraline, or a combination in childhood anxiety. N Engl J Med. 2008 Dec 25;359(26):2753-66. doi: 10.1056/NEJMoa0804633. Epub 2008 Oct 30.'}, {'pmid': '11323729', 'type': 'BACKGROUND', 'citation': 'Fluvoxamine for the treatment of anxiety disorders in children and adolescents. The Research Unit on Pediatric Psychopharmacology Anxiety Study Group. N Engl J Med. 2001 Apr 26;344(17):1279-85. doi: 10.1056/NEJM200104263441703.'}, {'pmid': '29071764', 'type': 'DERIVED', 'citation': 'Schneier FR, Moskow DM, Choo TH, Galfalvy H, Campeas R, Sanchez-Lacay A. A randomized controlled pilot trial of vilazodone for adult separation anxiety disorder. Depress Anxiety. 2017 Dec;34(12):1085-1095. doi: 10.1002/da.22693. Epub 2017 Oct 25.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Vilazodone (Viibryd), an SSRI and 5HT1a receptor agonist, is effective in treating Adult Separation Anxiety Disorder over a 12-week treatment course.', 'detailedDescription': 'In this randomized clinical trial, 40 adults with a principal diagnosis of Adult Separation Anxiety Disorder (ASAD) and no major depression or substance abuse disorders will be randomized to 12 weeks of treatment with vilazodone (flexibly dosed) or matched pill placebo. Outcome will be assessed in respect to symptomatic improvement, quality of life, adverse events and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Current primary (most clinically significant) diagnosis of DSM5 ASAD\n* Able to give consent, fluent in English\n\nExclusion Criteria:\n\n* Past or current DSM-IV diagnosis of any psychotic disorder; organic mental disorder or other cognitive disorder; bipolar disorder; or antisocial personality disorder. Current MDD of moderate or greater severity. Any other current primary Axis I disorder.\n* Recent history (past 3 months) of substance or alcohol abuse or dependence (other than nicotine or caffeine)\n* Suicidal ideation or behavior (in the past year) that poses a significant danger to the subject\n* Medical illness that could significantly increase risk of vilazodone treatment or interfere with assessment of diagnosis or treatment response, including organic brain impairment from stroke, CNS tumor, or demyelinating disease; renal impairment; diabetes mellitus\n* Current or past history of seizure disorder (except febrile seizure in childhood)\n* History of non-response to ≥ 2 serotonergic reuptake inhibitor antidepressants (SSRIs and/or SNRIs) for the treatment of ASAD after adequate treatment trials (adequate treatment is defined as at least 8 weeks at an adequate dose\\[s\\] based on approved package insert recommendations)\n* Currently taking medication which has been effective for patient's ASAD\n* For patients taking any ineffective psychoactive drug or herbal remedy, inability to tolerate or unwillingness to accept a drug-free period prior to beginning the study of 2 weeks or 5 half-lives (whichever is longer) before beginning study treatment, or ever having been treated with a depot antipsychotic. Fluoxetine washout period will be at least 5 weeks.\n* Requiring concomitant treatment with any prohibited medications, supplements, or herbal remedies, except for zolpidem, or zolpidem extended release for insomnia, which may be continued provided the medication has been used in a consistent manner for 4 weeks prior to randomization\n* History of intolerance or hypersensitivity to vilazodone, SNRIs or SSRIs\n* History of light therapy, electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation, or any other experimental procedure for central nervous system disorders within 6 months of beginning this study\n* Pregnancy, lactation; for women of childbearing potential, not using an effective birth control method (e.g., oral contraceptive or double barrier method) for the duration of the study\n* Current formal psychotherapy initiated within 3 months of beginning this study. This includes: psychodynamic, cognitive-behavioral and interpersonal therapies"}, 'identificationModule': {'nctId': 'NCT01999920', 'briefTitle': 'Vilazodone for Separation Anxiety Disorder', 'organization': {'class': 'OTHER', 'fullName': 'New York State Psychiatric Institute'}, 'officialTitle': 'Vilazodone for Separation Anxiety Disorder', 'orgStudyIdInfo': {'id': '#6856'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vilazodone', 'description': 'Vilazodone treatment. Dosage will begin at 10mg/day and will be increased to 20mg/day after 1 week, and 40mg/day after two weeks (optional). Dosage can be held steady or lowered at any time during the study as clinically indicated in the event of adverse effects. Twelve weeks of treatment, total.', 'interventionNames': ['Drug: Vilazodone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Pill placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vilazodone', 'type': 'DRUG', 'otherNames': ['Viibryd (brand name)'], 'description': '10mg to 40mg per day for 12 weeks', 'armGroupLabels': ['Vilazodone']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'One to two pills per day for 12 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York State Psychiatric Institute', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Franklin Schneier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYSPI'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York State Psychiatric Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Forest Laboratories', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}