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

Phase 2

Completed

• Conditions: Depressive Disorder
• Interventions: Drug: placebo; Drug: GSK372475; Drug: venlafaxine

• Registration Number: NCT00448058
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2007-03-13
• Study First Submitted QC: 2007-03-13
• Study First Posted: 2007-03-15
• Study Start: 2007-04
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Disposition First Submitted: 2009-11-30
• Disposition First Submitted QC: 2009-11-30
• Disposition First Posted: 2009-12-02
• Status Verified: 2011-11
• Last Update Submitted: 2014-10-02
• Last Update Posted: 2014-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 396

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
GSK372475	GSK372475	flexible-dose design from GSK372475 1.0 mg/day to GSK372475 2.0 mg/day
Venlafaxine	venlafaxine	Flexible- dose design from Venlafaxine XR 75 mg/day to Venlafaxine XR 225 mg/day

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

GSK Investigational Site; 🇿🇦 Vereeniging, South Africa