Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00105989
First received: March 18, 2005
Last updated: July 21, 2009
Last verified: July 2009
  Purpose

The purpose of this study is to assess the efficacy and safety of duloxetine compared with placebo in the prevention of depressive recurrences among patients with recurrent major depressive disorder.


Condition Intervention Phase
Depressive Disorder, Major
Drug: Duloxetine
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Percentage of Participants With Depressive Recurrence After Time (t) in Days [ Time Frame: Every Visit from Week 34 up to Week 86 (Maintenance Phase) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrence Count [ Time Frame: Every Visit from Week 35 up to Week 86 (Maintenance Phase) ] [ Designated as safety issue: No ]
  • Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days [ Time Frame: Every Visit from Week 34 up to Week 86 (Maintenance Phase) ] [ Designated as safety issue: No ]
  • Loss of Response at Any Time [ Time Frame: Every Visit from Week 35 up to Week 86 (Maintenance Phase) ] [ Designated as safety issue: No ]
  • Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Acute and Continuation Phases [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ] [ Designated as safety issue: No ]
  • Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ] [ Designated as safety issue: No ]
  • Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Acute and Continuation Phases [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ] [ Designated as safety issue: No ]
  • Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ] [ Designated as safety issue: No ]
  • Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Acute and Continuation Phases [ Time Frame: Week 10 (Acute) and Week 34 (Continuation) ] [ Designated as safety issue: No ]
  • Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Maintenance Phase [ Time Frame: Week 86 (Maintenance Phase) ] [ Designated as safety issue: No ]
  • Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ] [ Designated as safety issue: No ]
  • Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ] [ Designated as safety issue: No ]
  • Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ] [ Designated as safety issue: No ]
  • Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ] [ Designated as safety issue: No ]
  • Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Acute and Continuation Phases [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ] [ Designated as safety issue: No ]
  • Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ] [ Designated as safety issue: No ]
  • Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ] [ Designated as safety issue: No ]
  • Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ] [ Designated as safety issue: No ]
  • Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ] [ Designated as safety issue: No ]
  • Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ] [ Designated as safety issue: No ]
  • Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases [ Time Frame: Week 0 through Week10 (Acute) through Week 34 (Continuation) ] [ Designated as safety issue: No ]
  • Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase [ Time Frame: Week 34 through Week 86 (Maintenance Phase) ] [ Designated as safety issue: No ]
  • Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Acute and Continuation Phases [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ] [ Designated as safety issue: No ]
  • Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ] [ Designated as safety issue: No ]
  • Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Acute and Continuation Phase [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ] [ Designated as safety issue: No ]
  • Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ] [ Designated as safety issue: No ]
  • Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ] [ Designated as safety issue: Yes ]
  • Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ] [ Designated as safety issue: Yes ]
  • Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males) [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ] [ Designated as safety issue: Yes ]
  • Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females) [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ] [ Designated as safety issue: Yes ]
  • Vital Signs - Change From Baseline to Endpoint in Weight - Acute and Continuation Phases [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ] [ Designated as safety issue: Yes ]
  • Vital Signs - Change From Baseline to Endpoint in Weight - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ] [ Designated as safety issue: Yes ]
  • Vital Signs - Change From Baseline to Endpoint in Pulse - Acute and Continuation Phases [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ] [ Designated as safety issue: Yes ]
  • Vital Signs - Change From Baseline to Endpoint in Pulse - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ] [ Designated as safety issue: Yes ]
  • Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ] [ Designated as safety issue: Yes ]
  • Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Acute Phase [ Time Frame: Week 0 and Week 10 ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Acute Phase [ Time Frame: Week 0 and Week 10 ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Chloride - Acute Phase [ Time Frame: Week 0 and Week 10 ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Eosinophils - Acute Phase [ Time Frame: Week 0 and Week 10 ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Acute Phase [ Time Frame: Week 0 and Week 10 ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Acute Phase [ Time Frame: Week 0 and Week 10 ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Acute Phase [ Time Frame: Week 0 and Week 10 ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Platelet Count - Acute Phase [ Time Frame: Week 0 and Week 10 ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Sodium - Acute Phase [ Time Frame: Week 0 and Week 10 ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Acute Phase [ Time Frame: Week 0 and Week 10 ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Uric Acid - Acute Phase [ Time Frame: Week 0 and Week 10 ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bicarbonate, HCO3 - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Direct - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Total - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Erythrocyte Count - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Leukocyte Count - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Low Density Lipoprotein (LDL) Cholesterol (Direct) - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Hemoglobin - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Volume (MCV) - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Monocytes - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Alanine Aminotransferase (ALT) - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ] [ Designated as safety issue: Yes ]
  • Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ] [ Designated as safety issue: Yes ]
  • Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase [ Time Frame: Every Visit from Week 0 up to Week 10 (Acute) ] [ Designated as safety issue: Yes ]
  • Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase [ Time Frame: Every Visit from Week 10 up to Week 34 (Continuation) ] [ Designated as safety issue: Yes ]

Enrollment: 514
Study Start Date: March 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks
Drug: Duloxetine
Other Names:
  • LY248686
  • Cymbalta
Placebo Comparator: B
duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks
Drug: placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must be at least 18 years old.
  • Patient must be diagnosed with depression and have had previous episodes of depression.
  • Patient must sign informed consent.

Exclusion Criteria:

  • Female and pregnant or breastfeeding.
  • History of bipolar disorder, schizophrenia, or other psychotic disorders.
  • Suffer from a serious medical illness (other than depression) or abnormal laboratory result that would require a change in medication, intervention, or hospitalization.
  • Have been treated with a medication called monoamine oxidase inhibitor (MAOI) within 14 days of the start of the study, or potential need to use a MAOI within 5 days of finishing the study.
  • Have taken an antidepressant called fluoxetine within 30 days of the start of the study.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00105989

Locations
United States, California
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Newport Beach, California, United States
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Sherman Oaks, California, United States
United States, Maryland
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Baltimore, Maryland, United States
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Gaithersburg, Maryland, United States
United States, New York
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Brooklyn, New York, United States
France
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Angouleme, France
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Douai, France
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Fains, France
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La Rochelle, France
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Lille, France
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Nimes, France
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Roubaix, France
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Strasbourg, France
Germany
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Berlin, Germany
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Ellwangen, Germany
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Hamburg, Germany
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Hildesheim, Germany
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Leipzig, Germany
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Munchen, Germany
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Wurzburg, Germany
Italy
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Catania, Italy
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Ferrara, Italy
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Firenze, Italy
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Parma, Italy
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Roma, Italy
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Torino, Italy
Russian Federation
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Moscow, Russian Federation
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St. Petersburg, Russian Federation
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Village Nikolskoe, Russian Federation
Sweden
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Halmstad, Sweden
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Lund, Sweden
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Malmo, Sweden
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Stockholm, Sweden
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Sundsvall, Sweden
Sponsors and Collaborators
Eli Lilly and Company
Boehringer Ingelheim
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00105989     History of Changes
Other Study ID Numbers: 8606, F1J-MC-HMDI
Study First Received: March 18, 2005
Results First Received: January 23, 2009
Last Updated: July 21, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Recurrence
Behavioral Symptoms
Disease Attributes
Mental Disorders
Mood Disorders
Pathologic Processes
Duloxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Antidepressive Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014