Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-03-04 @ 12:25 PM
Study NCT ID:
NCT00200902
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2005-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Depression Symptoms and Brain Activity Associated With Response to Treatment of Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069470', 'term': 'Venlafaxine Hydrochloride'}, {'id': 'D000068736', 'term': 'Duloxetine Hydrochloride'}, {'id': 'D000089983', 'term': 'Escitalopram'}], 'ancestors': [{'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic 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': 'jpv@brain.ucla.edu', 'phone': '310-825-0207', 'title': 'Andrew Leuchter, MD', 'organization': 'Laboratory of Brain, Behavior, and Pharmacology at the University of California Los Angeles'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Individuals entering this study were aware that they might be assigned to a treatment condition that did not involve the use of medication; it is not certain that they are representative of people with MDD who would enter clinical trials for MDD.'}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Medication', 'description': 'Venlafaxine (Effexor), Duloxetine (Cymbalta), or Escitalopram (Lexapro) + ICI', 'otherNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo (PBO)', 'description': 'Placebo + ICI', 'otherNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Interpersonal Clinical Interaction (ICI)', 'description': 'ICI ONLY', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Response as Assessed by Participants' Change in Depression Rating", 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MEDICATIONS', 'description': 'Three different types of medications were utilized and assigned specifically to each subject depending on their condition. Interpersonal clinical interaction (ICI) plus clinically assigned medication (Venlafaxine XR, Duloxetine, or Escitalopram).'}, {'id': 'OG001', 'title': 'Placebo (PBO)', 'description': 'Interpersonal clinical interaction (ICI) plus placebo'}, {'id': 'OG002', 'title': 'Interpersonal Clinical Interaction (ICI)', 'description': 'Interpersonal clinical interaction (ICI) ONLY'}], 'classes': [{'title': 'Responders', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Remitters', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 8', 'description': 'Comparison of treatment arms (Medication + ICI, Placebo+ICI, and ICI only). The Hamilton Depression Rating Scale (HAM-D-17) used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52.Response is defined as a 50% decrease in HAMD-17 scoring. Remission defined as a HAMD-17 score of 7 or less.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing the Week 8 visit were included in the analysis (n=67)'}, {'type': 'PRIMARY', 'title': 'Average Change in 3 Weeks of Participant Treatment Expectations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication (MED)', 'description': 'MED 1-venlafaxine XR, MED 2-Duloxetine (Cymbalta), MED 3-Escitalopram (Lexapro)'}, {'id': 'OG001', 'title': 'Placebo (PBO)', 'description': 'Placebo subjects received interpersonal clinical interaction (ICI) along with placebo treatment.\n\nPlacebo: Subjects assigned to the placebo (PBO) or medication (MED) condition entered double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They underwent the same schedule, structure, and intensity of visits as in the ICI condition, but also were randomized to receive treatment with a pill. Subjects randomized to medication started on one tablet each morning of either venlafaxine XR 75 mg., duloxetine 30 mg., or escitalopram 10 mg. Dosages will be increased in a double-blinded manner by increasing the number of pills administered by one pill every three to five days until the final dose is achieved (225 mg., 90 mg., and 30 mg. respectively for venlafaxine XR, duloxetine, and escitalopram). In order to maintain blinding during dosage increase, the number of tablets of placebo will be increased every three to five days as well.'}, {'id': 'OG002', 'title': 'Interpersonal Clinical Interaction (ICI)', 'description': 'Interpersonal Clinical Interaction (ICI) ONLY'}], 'classes': [{'categories': [{'measurements': [{'value': '3.55', 'spread': '.78', 'groupId': 'OG000'}, {'value': '3.94', 'spread': '.61', 'groupId': 'OG001'}, {'value': '3.17', 'spread': '1.16', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Averaged over 3 time points (Baseline, randomization, and end of lead-in)', 'description': "Patient Attitudes and Expectations Form used for assessing expectation. The California Pharmacotherapy Alliance Scale, a measure associated with outcomes of antidepressant pharmacotherapy, used to measure participants' perceptions of: (a) participants' commitment to treatment; (b) participants' working capacity; (c) treatment providers' understanding and involvement; and (d) goal and working strategy consensus between participant and treatment provider. This is a 24-item questionnaire with a 7-point Likert scale (1 = not at all, 7 = very much so). Total score ranges from a minimum of 0 and a maximum of 120. The score is determined by a combination of negative and positive items. To assure negative items are reflected, subtract each of the negative item ratings from 8; for example, a rating of 1 becomes 7 (8 minus 1). The scores are computed by summing the items and dividing the total by 6 to procure the mean rating. A lower score indicates a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '88 participants who completed the first 3 time points in the study'}, {'type': 'PRIMARY', 'title': 'Change in Hamilton Depression Assessment Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication (MED)', 'description': 'Venlafaxine (Effexor), Duloxetine (Cymbalta), or Escitalopram (Lexapro) + ICI'}, {'id': 'OG001', 'title': 'Placebo (PBO)', 'description': 'Placebo + ICI'}, {'id': 'OG002', 'title': 'Interpersonal Clinical Interaction (ICI)', 'description': 'ICI ONLY'}], 'classes': [{'title': 'Percent Change in HAM-D', 'categories': [{'measurements': [{'value': '-0.46', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '-0.36', 'spread': '0.39', 'groupId': 'OG001'}, {'value': '-0.05', 'spread': '0.27', 'groupId': 'OG002'}]}]}, {'title': 'Change in HAM-D', 'categories': [{'measurements': [{'value': '-10.05', 'spread': '6.60', 'groupId': 'OG000'}, {'value': '-7.59', 'spread': '7.98', 'groupId': 'OG001'}, {'value': '-1.37', 'spread': '5.27', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline,Week 8', 'description': 'Comparison of treatment arms (Medication + ICI, Placebo+ICI, and ICI only). The Hamilton Depression Rating Scale used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression/worse outcome. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52.', 'unitOfMeasure': 'HAMD score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MEDS + ICI', 'description': 'MED 1-venlafaxine XR, MED 2-Duloxetine (Cymbalta), MED 3-Escitalopram (Lexapro)'}, {'id': 'FG001', 'title': 'Placebo+ICI'}, {'id': 'FG002', 'title': 'ICI Alone', 'description': 'Subjects assigned to the interpersonal clinical interaction (ICI). Visits will involve a session with a research nurse that will be approximately 20 minutes in length; visits at baseline, end of lead-in, and 1, 2, 4, and 8 weeks also will include a brief (5-10 minutes) meeting with a physician.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Overall for this study, n=67 assessed for many measures in Results section.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '8'}]}]}], 'recruitmentDetails': '133 subjects were screened for eligibility and 88 were eligible for enrollment between 8/19/05 - 8/7/08 at the UCLA Laboratory of Brain, Behavior, and Pharmacology. 88 participants were randomized however, n=67 for many of the measures as subjects who did not complete the Week 8 visit were not included in the analysis.', 'preAssignmentDetails': 'Subjects were required to wash out of any other antidepressant medications for one week (30 days if washing out from fluoxetine).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Medication Treatment (MED)', 'description': 'MED 1-venlafaxine XR, MED 2-Duloxetine (Cymbalta), MED 3-Escitalopram (Lexapro)'}, {'id': 'BG001', 'title': 'Placebo'}, {'id': 'BG002', 'title': 'Interpersonal Clinical Interaction', 'description': 'Subjects assigned to the interpersonal clinical interaction (ICI). Visits involve a session with a research nurse that will be approximately 20 minutes in length; visits at baseline, end of lead-in, and 1, 2, 4, and 8 weeks also will include a brief (5-10 minutes) meeting with a physician.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.67', 'spread': '13.63', 'groupId': 'BG000'}, {'value': '41.75', 'spread': '14.35', 'groupId': 'BG001'}, {'value': '43.1', 'spread': '12.7', 'groupId': 'BG002'}, {'value': '41.96', 'spread': '13.74', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-09', 'studyFirstSubmitDate': '2005-09-14', 'resultsFirstSubmitDate': '2018-05-25', 'studyFirstSubmitQcDate': '2005-09-14', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-21', 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Response as Assessed by Participants' Change in Depression Rating", 'timeFrame': 'Baseline, Week 8', 'description': 'Comparison of treatment arms (Medication + ICI, Placebo+ICI, and ICI only). The Hamilton Depression Rating Scale (HAM-D-17) used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52.Response is defined as a 50% decrease in HAMD-17 scoring. Remission defined as a HAMD-17 score of 7 or less.'}, {'measure': 'Average Change in 3 Weeks of Participant Treatment Expectations', 'timeFrame': 'Averaged over 3 time points (Baseline, randomization, and end of lead-in)', 'description': "Patient Attitudes and Expectations Form used for assessing expectation. The California Pharmacotherapy Alliance Scale, a measure associated with outcomes of antidepressant pharmacotherapy, used to measure participants' perceptions of: (a) participants' commitment to treatment; (b) participants' working capacity; (c) treatment providers' understanding and involvement; and (d) goal and working strategy consensus between participant and treatment provider. This is a 24-item questionnaire with a 7-point Likert scale (1 = not at all, 7 = very much so). Total score ranges from a minimum of 0 and a maximum of 120. The score is determined by a combination of negative and positive items. To assure negative items are reflected, subtract each of the negative item ratings from 8; for example, a rating of 1 becomes 7 (8 minus 1). The scores are computed by summing the items and dividing the total by 6 to procure the mean rating. A lower score indicates a worse outcome."}, {'measure': 'Change in Hamilton Depression Assessment Score', 'timeFrame': 'Baseline,Week 8', 'description': 'Comparison of treatment arms (Medication + ICI, Placebo+ICI, and ICI only). The Hamilton Depression Rating Scale used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression/worse outcome. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Major depressive disorder', 'MDD', 'Antidepressant'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '25213159', 'type': 'DERIVED', 'citation': 'Leuchter AF, Hunter AM, Tartter M, Cook IA. Role of pill-taking, expectation and therapeutic alliance in the placebo response in clinical trials for major depression. Br J Psychiatry. 2014 Dec;205(6):443-9. doi: 10.1192/bjp.bp.113.140343. Epub 2014 Sep 11.'}], 'seeAlsoLinks': [{'url': 'http://www.DepressionResearch.com/', 'label': 'Depression Research - Click here for more information about this study: Psychobiologic Factors of the Placebo Response in MDD'}]}, 'descriptionModule': {'briefSummary': "This study will use measurements of depression symptoms and brain activity to determine what factors may influence an individual's response to treatment for depression.", 'detailedDescription': 'We are using depression symptom measurements and measurements of brain electrical activity (EEG) to determine what factors may influence whether a patient is likely to show a response to antidepressant medication, placebo, or only clinical visits (without the use of pills) during a treatment trial for depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of unipolar major depression\n\nExclusion Criteria:\n\n* Substance abuse\n* Psychotic disorder\n* History of severe head trauma'}, 'identificationModule': {'nctId': 'NCT00200902', 'briefTitle': 'Evaluation of Depression Symptoms and Brain Activity Associated With Response to Treatment of Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Factors of Treatment Response in Major Depressive Disorder', 'orgStudyIdInfo': {'id': 'R01AT002479-02', 'link': 'https://reporter.nih.gov/quickSearch/R01AT002479-02', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01AT002479-02', 'link': 'https://reporter.nih.gov/quickSearch/R01AT002479-02', 'type': 'NIH'}, {'id': '04-02-068'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MED', 'description': 'For medication treatment, three different types were utilized and assigned specifically to each subject depending on their condition:\n\nMED 1: Venlafaxine XR. MED 2: Duloxetine (Cymbalta) MED 3: Escitalopram (Lexapro)', 'interventionNames': ['Drug: Venlafaxine (Effexor), Duloxetine (Cymbalta), Escitalopram (Lexapro)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (PBO)', 'description': 'Subjects enrolled will receive interpersonal clinical interaction (ICI) along with a placebo treatment (Interaction and assessment as in ICI plus double blinded treatment with placebo tablets).', 'interventionNames': ['Other: Placebo']}, {'type': 'OTHER', 'label': 'Interpersonal Clinical Interaction (ICI)', 'description': 'Subjects assigned to the interpersonal clinical interaction (ICI) will undergo a one-week waiting period after the initial assessment. Visits will involve a session with a research nurse that will be approximately 20 minutes in length; visits at baseline, end of lead-in, and 1, 2, 4, and 8 weeks also will include a brief (5-10 minutes) meeting with a physician.', 'interventionNames': ['Behavioral: Interpersonal Clinical Interaction (ICI)']}], 'interventions': [{'name': 'Venlafaxine (Effexor), Duloxetine (Cymbalta), Escitalopram (Lexapro)', 'type': 'DRUG', 'description': 'Subjects assigned to the placebo (PBO) or medication (MED) condition will enter double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They will undergo the same schedule, structure, and intensity of visits as in the ICI condition, but also will be randomized to receive treatment with a pill. Subjects randomized to medication will be started on one tablet each morning of either venlafaxine XR 75 mg., duloxetine 30 mg., or escitalopram 10 mg. Dosages will be increased in a double-blinded manner by increasing the number of pills administered by one pill every three to five days until the final dose is achieved (225 mg., 90 mg., and 30 mg. respectively for venlafaxine XR, duloxetine, and escitalopram). In order to maintain blinding during dosage increase, the number of tablets of placebo will be increased every three to five days as well.', 'armGroupLabels': ['MED']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Subjects assigned to the placebo (PBO) or medication (MED) condition will enter double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They will undergo the same schedule, structure, and intensity of visits as in the ICI condition, but also will be randomized to receive treatment with a pill. Subjects randomized to medication will be started on one tablet each morning of either venlafaxine XR 75 mg., duloxetine 30 mg., or escitalopram 10 mg. Dosages will be increased in a double-blinded manner by increasing the number of pills administered by one pill every three to five days until the final dose is achieved (225 mg., 90 mg., and 30 mg. respectively for venlafaxine XR, duloxetine, and escitalopram). In order to maintain blinding during dosage increase, the number of tablets of placebo will be increased every three to five days as well.', 'armGroupLabels': ['Placebo (PBO)']}, {'name': 'Interpersonal Clinical Interaction (ICI)', 'type': 'BEHAVIORAL', 'description': 'Interaction with and assessment by clinical research personnel on a fixed schedule, with the pharmacotherapeutic alliance assessed both by research personnel and subjects.', 'armGroupLabels': ['Interpersonal Clinical Interaction (ICI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Laboratory of Brain, Behavior, and Pharmacology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Andrew F. Leuchter, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}, {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry', 'investigatorFullName': 'Andrew F. Leuchter', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}