A Study Of New Medicine (GSK 372475) For The Treatment Of Depression

Study Overview
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Brief Summary
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To evaluate the efficacy, safety, and tolerability of GSK372475 compared with placebo in the treatment of outpatient subjects with Major Depressive Disorder (MDD)

Detailed Description
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A Ten-Week, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Flexible-Dose Study Evaluating the Efficacy, Safety, and Tolerability of GSK372475 (1.5 mg/day to 2.0 mg/day) or Extended Release Venlafaxine XR (150 mg/day to 225 mg/day) Compared to Placebo in Adult Subjects Diagnosed with Major Depressive Disorder

Official Title
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A Ten-Week, Multicenter, Randomized, Double-Blind, Placebo and Active-Controlled, Parallel-Group, Flexible-Dose Study Evaluating the Efficacy, Safety, and Tolerability of GSK372475 (1.5 mg/Day to 2.0 mg/Day) or Extended Release Venlafaxine XR (150 mg/Day to 225 mg/Day) Compared to Placebo in Adult s

Conditions
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Depressive Disorder

Intervention / Treatment
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* Drug: GSK372475
* Drug: venlafaxine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major depressive episode (MDE) associated with Major Depressive Disorder (DSM-IV-TR criteria) Duration of current episode is at least 12 weeks duration and less than 2 years Symptoms of decreased energy, pleasure, and interest Female subjects who agree to use acceptable methods of birth control throughout the study Exclusion criteria: Current diagnosis of Panic Disorder, or symptoms of generalized anxiety or panic attacks that could interfere with their ability to complete the trial Symptoms of MDE better accounted for by another diagnosis Diagnosis of Bipolar, schizophrenia, other psychotic disorder(s), borderline or antisocial personality disorder, or dementia. Started psychotherapy within 3 months prior to the Screening Received electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior to screening Received psychoactive drugs within 4 weeks of randomization Positive urine drug screen or positive blood alcohol Suicidal risk or has had any previous suicide attempt, a family history of suicide attempt Positive pregnancy test History of seizure disorder, myocardial infarction (< 1yr), or unstable medical condition Failed to respond to an adequate course of pharmacotherapy of at least 2 different antidepressants

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GSK372475<br>flexible-dose design from GSK372475 1.0 mg/day to GSK372475 2.0 mg/day | Drug: GSK372475<br>* daily administration during the 10-week treatment phase<br>|
| Active Comparator: Venlafaxine<br>Flexible- dose design from Venlafaxine XR 75 mg/day to Venlafaxine XR 225 mg/day | Drug: venlafaxine<br>* daily administration during the 10-week treatment phase<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* daily administration during the 10-week treatment phase<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from randomization to the end of the Treatment Phase (Week 10) on a depression rating scale. |  | Randomisation (week 0) And end of the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endpoints related to response & remission on depression rating scales during time of treatment exposureChange during treatment & at endpoint-week 10:in Clinical Global Impression scale; in motivation, energy, & sexual functioning on patient-rated scales |  | Randomisation (week 0) and at weeks 1,2,4,6,8 and week 10 (end of treatment phase) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flexible-dose, GSK372475, MDD, Venlafaxine XR, Major Depressive Disorder