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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Depressive Disorder

Treatments: Drug: placebo; Drug: GSK372475; Drug: venlafaxine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00448058

SND 103285

Details and patient eligibility

About

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

Full 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

Enrollment: 396 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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396 participants in 3 patient groups, including a placebo group

GSK372475

Experimental group

Description:

flexible-dose design from GSK372475 1.0 mg/day to GSK372475 2.0 mg/day

Treatment:

Drug: GSK372475

Venlafaxine

Active Comparator group

Description:

Flexible- dose design from Venlafaxine XR 75 mg/day to Venlafaxine XR 225 mg/day

Treatment:

Drug: venlafaxine

placebo

Placebo Comparator group

Treatment:

Drug: placebo