Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT01254305
Status:
COMPLETED
Last Update Posted:
2014-08-06
First Post:
2010-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Adults With Fatigue Associated With Major Depressive Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078862', 'term': 'Levomilnacipran'}, {'id': 'D017374', 'term': 'Paroxetine'}, {'id': 'D020280', 'term': 'Sertraline'}, {'id': 'D015283', 'term': 'Citalopram'}, {'id': 'D005473', 'term': 'Fluoxetine'}], 'ancestors': [{'id': 'D000078764', 'term': 'Milnacipran'}, {'id': 'D003521', 'term': 'Cyclopropanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'carl.gommoll@frx.com', 'phone': '201-427-8000', 'title': 'Carl Gommoll, MS, Sr. Dir. Clinical Development Psychiatry', 'phoneExt': '8124', 'organization': 'Forest Research Institute'}, 'certainAgreement': {'otherDetails': 'All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study.\n\nPublication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data occurred over a 16-month period from April of 2011 to September of 2012 at 20 studies sites in the United States.', 'description': 'The Serious Adverse Event data presented here is for the safety population. The Other Adverse Event data presented here is for the safety population during the 8 week double-blind treatment period.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Matching placebo capsules, oral administration\n\nPlacebo : Matching placebo capsules, oral administration, once daily dosing', 'otherNumAtRisk': 89, 'otherNumAffected': 39, 'seriousNumAtRisk': 89, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Levomilnacipran ER', 'description': '40 -120 mg Levomilnacipran ER capsules, oral administration, once daily for 8 weeks', 'otherNumAtRisk': 85, 'otherNumAffected': 41, 'seriousNumAtRisk': 85, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'SSRI', 'description': 'Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.\n\nParoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks.', 'otherNumAtRisk': 77, 'otherNumAffected': 37, 'seriousNumAtRisk': 77, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Initial insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Clinical Global Impression of Severity (CGI-S) for Fatigue Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dose matched placebo, oral administration in capsule form, once daily for 8 weeks'}, {'id': 'OG001', 'title': 'Levomilnacipran ER', 'description': '40 - 120 mg Levomilnacipran ER capsules, oral administration in capsule form, once daily for 8 weeks'}, {'id': 'OG002', 'title': 'SSRI', 'description': 'Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.\n\nParoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '1.4', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '1.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Week 8', 'description': "The CGI-S is a clinician-rated scale that rates the severity of the patient's current state of fatigue based on the Investigator's clinical opinion with regard to the patient population with Major Depressive Disorder (MDD). Patient were rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating that the patient was among the most extremely fatigued", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized Population consisted of 262 patients, with 251 patients who took at least 1 dose of double-blind treatment to comprise the Safety population.\n\nThe Intent-to-Treat (ITT) Population consisted of 248 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of either the CGI-S or PGI-I fatigue score.'}, {'type': 'SECONDARY', 'title': 'Change in Cognitive and Physical Functioning Questionnaire (CPFQ), Last Observation Carried Forward', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dose matched placebo capsules, oral administration for 8 weeks.'}, {'id': 'OG001', 'title': 'Levomilnacipran ER', 'description': '40 - 120 mg Levomilnacipran ER capsules, oral administration once per day for 8 weeks'}, {'id': 'OG002', 'title': 'SSRI', 'description': 'Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.\n\nParoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.9', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '-7.0', 'spread': '7.3', 'groupId': 'OG001'}, {'value': '-6.4', 'spread': '7.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Week 8', 'description': 'The Cognitive and Physical Functioning Questionnaire is a patient-rated, 7-item scale used to measure cognitive and executive dysfunction in mood and anxiety disorders. The CPFQ is sensitive to change with treatment and displays convergent validity by significant correlations with other measures of sleepiness, fatigue, apathy, and neuropsychological functioning. Patients are rated on a scale from 1 to 6 for seven common complaints of depressed patients reporting fatigue or cognitive/executive problems-with 1 indicating greater than normal functioning, 2 indicating normal functioning, and 3 to 6 indicating degrees of impaired functioning. The CPFQ ranges from the best possible score of 7 (greater than normal functioning) to the worst possible score of 42 (totally absent).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized Population consisted of 262 patients, with 251 patients who took at least 1 dose of double-blind treatment to comprise the Safety population.'}, {'type': 'PRIMARY', 'title': 'Change in Patient Global Impressions of Severity (PGI-S) for Fatigue Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Dose matched placebo, oral administration in capsule form, once daily for 8 weeks'}, {'id': 'OG001', 'title': 'Levomilnacipran ER', 'description': '40 - 120 mg Levomilnacipran ER capsules, oral administration once per day for 8 weeks.'}, {'id': 'OG002', 'title': 'SSRI', 'description': 'Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.\n\nParoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '1.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Week 8', 'description': "The PGI-S is a clinician-rated scale that rates was used to rate the severity of the patient's current state of overall fatigue. Patients were rated on a scale from 1 to 7, with 1 indicating no symptoms of fatigue and 7 indicating extreme fatigue.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Randomized Population consisted of 262 patients, with 251 patients who took at least 1 dose of double-blind treatment to comprise the Safety population.\n\nThe Intent-to-Treat (ITT) Population consisted of 248 patients in the Safety Population who had a baseline and at least 1 postbaseline assessment of either the CGI-S or PGI-I fatigue score.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Matching placebo capsules, oral administration, once daily dosing.'}, {'id': 'FG001', 'title': 'Levomilnacipran ER', 'description': '40 -120 mg Levomilnacipran ER capsules, oral administration once daily for 8 weeks.'}, {'id': 'FG002', 'title': 'SSRI', 'description': 'Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.\n\nParoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '90'}, {'groupId': 'FG002', 'numSubjects': '79'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '85'}, {'groupId': 'FG002', 'numSubjects': '77'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '72'}, {'groupId': 'FG002', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Other Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Patients were recruited over a 12-month period from April of 2011 to April of 2012 at 20 studies sites in the United States.', 'preAssignmentDetails': 'Patients went through a 1-week single-blind placebo run-in period, followed by an 8-week double-blind treatment period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '251', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Matching placebo capsules, oral administration\n\nPlacebo : Matching placebo capsules, oral administration, once daily dosing'}, {'id': 'BG001', 'title': 'Levomilnacipran ER', 'description': '40 - 120 mg Levomilnacipran ER capsules, oral administration, once daily for 8 weeks'}, {'id': 'BG002', 'title': 'SSRI', 'description': 'Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.\n\nParoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.4', 'spread': '12.0', 'groupId': 'BG000'}, {'value': '42.9', 'spread': '12.6', 'groupId': 'BG001'}, {'value': '42.8', 'spread': '11.3', 'groupId': 'BG002'}, {'value': '42.3', 'spread': '12.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '229', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '251', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '79.95', 'spread': '15.27', 'groupId': 'BG000'}, {'value': '82.23', 'spread': '18.14', 'groupId': 'BG001'}, {'value': '83.31', 'spread': '17.61', 'groupId': 'BG002'}, {'value': '81.75', 'spread': '17.00', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '28.16', 'spread': '4.85', 'groupId': 'BG000'}, {'value': '28.61', 'spread': '5.22', 'groupId': 'BG001'}, {'value': '28.80', 'spread': '5.10', 'groupId': 'BG002'}, {'value': '28.51', 'spread': '5.04', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms Per Meter Squared', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'A total of 262 patients were randomized to receive double-blind treatment. The Baseline Participant population is based on the 251 randomized patients received at least 1 dose of double-blind treatment (Safety Population).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 262}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'dispFirstSubmitDate': '2012-07-25', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-05', 'studyFirstSubmitDate': '2010-12-03', 'dispFirstSubmitQcDate': '2012-07-25', 'resultsFirstSubmitDate': '2013-08-22', 'studyFirstSubmitQcDate': '2010-12-03', 'dispFirstPostDateStruct': {'date': '2012-08-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-08-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-08-05', 'studyFirstPostDateStruct': {'date': '2010-12-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Clinical Global Impression of Severity (CGI-S) for Fatigue Score', 'timeFrame': 'From Baseline to Week 8', 'description': "The CGI-S is a clinician-rated scale that rates the severity of the patient's current state of fatigue based on the Investigator's clinical opinion with regard to the patient population with Major Depressive Disorder (MDD). Patient were rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating that the patient was among the most extremely fatigued"}, {'measure': 'Change in Patient Global Impressions of Severity (PGI-S) for Fatigue Score', 'timeFrame': 'From Baseline to Week 8', 'description': "The PGI-S is a clinician-rated scale that rates was used to rate the severity of the patient's current state of overall fatigue. Patients were rated on a scale from 1 to 7, with 1 indicating no symptoms of fatigue and 7 indicating extreme fatigue."}], 'secondaryOutcomes': [{'measure': 'Change in Cognitive and Physical Functioning Questionnaire (CPFQ), Last Observation Carried Forward', 'timeFrame': 'From Baseline to Week 8', 'description': 'The Cognitive and Physical Functioning Questionnaire is a patient-rated, 7-item scale used to measure cognitive and executive dysfunction in mood and anxiety disorders. The CPFQ is sensitive to change with treatment and displays convergent validity by significant correlations with other measures of sleepiness, fatigue, apathy, and neuropsychological functioning. Patients are rated on a scale from 1 to 6 for seven common complaints of depressed patients reporting fatigue or cognitive/executive problems-with 1 indicating greater than normal functioning, 2 indicating normal functioning, and 3 to 6 indicating degrees of impaired functioning. The CPFQ ranges from the best possible score of 7 (greater than normal functioning) to the worst possible score of 42 (totally absent).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Depression', 'Fatigue', 'Major Depressive Disorder'], 'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the efficacy, safety and tolerability of Levomilnacipran ER for the treatment of fatigue associated with major depressive disorder (MDD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women, 18-65 years old\n* Currently meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder\n* The patient's current depressive episode must be at least 4 weeks in duration\n\nExclusion Criteria:\n\n* Women who are pregnant, women who will be breastfeeding during the study, and women of child-bearing potential who are not practicing a reliable method of birth control\n* Patients with a history of meeting DSM-IV-TR criteria for:\n\n 1. any manic or hypomanic episode;\n 2. schizophrenia or any other psychotic disorder;\n 3. obsessive-compulsive disorder.\n* Patients who are considered a suicide risk"}, 'identificationModule': {'nctId': 'NCT01254305', 'briefTitle': 'Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Adults With Fatigue Associated With Major Depressive Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forest Laboratories'}, 'officialTitle': 'A Double-blind, Randomized, Placebo- and Active-Controlled Study of F2695 SR in Adult Patients With Fatigue Associated With Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'LVM-MD-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '40 -120 mg/day Levomilnacipran ER capsules, oral administration', 'interventionNames': ['Drug: Levomilnacipran ER']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine Oral administration, once daily dosing', 'interventionNames': ['Drug: Paroxetine, Sertraline, Citalopram or Fluoxetine.']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Matching placebo capsules, oral administration', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Levomilnacipran ER', 'type': 'DRUG', 'description': 'Drug: Levomilnacipran ER (40 -120 mg/day) Study drug is to be given orally, in capsule form, once daily for 8 weeks', 'armGroupLabels': ['1']}, {'name': 'Paroxetine, Sertraline, Citalopram or Fluoxetine.', 'type': 'DRUG', 'description': 'Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo capsules, oral administration, once daily dosing', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 010', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72223', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Forest Investigative Site 002', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90703', 'city': 'Cerritos', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 001', 'geoPoint': {'lat': 33.85835, 'lon': -118.06479}}, {'zip': '33912', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 014', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 006', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32763', 'city': 'Orange City', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 017', 'geoPoint': {'lat': 28.94888, 'lon': -81.29867}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 005', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 012', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Forest Investigative Site 009', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60435', 'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'facility': 'Forest Investigative Site 016', 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'zip': '70122', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Forest Investigative Site 004', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02135', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Forest Investigative Site 022', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '11516', 'city': 'Cedarhurst', 'state': 'New York', 'country': 'United States', 'facility': 'Forest Investigative Site 015', 'geoPoint': {'lat': 40.62288, 'lon': -73.7243}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Forest Investigative Site 011', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '45227', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Forest Investigative Site 003', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45417', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Forest Investigative Site 013', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '02865', 'city': 'Lincoln', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Forest Investigative Site 020', 'geoPoint': {'lat': 41.92111, 'lon': -71.435}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Forest Investigative Site 018', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Forest Investigative Site 008', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '53562', 'city': 'Middleton', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Forest Investigative Site 007', 'geoPoint': {'lat': 43.09722, 'lon': -89.50429}}], 'overallOfficials': [{'name': 'Carl Gommoll, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Forest Laboratories'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Forest Laboratories', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}