MDD POC Study GSK372475 Subjects Depressive Disease

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Depressive Disorder

Treatments: Drug: GSK372475; Drug: Paroxetine; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00420641

SND 103288

Details and patient eligibility

About

To evaluate the efficacy, safety and tolerability of GSK372475 compared with placebo in the treatment of outpatients subjects with major depressive disorder to exhibit decreased pleasure, interest and energy.

Enrollment: 492 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 panic disorder / attacks, generalised anxiety, borderline or antisocial personality disorder, dementia, anorexia nervosa / bulimia (within 6 months of screening), bipolar disorder, schizophrenia or any other psychotic disorder(s).
• 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: Double Blind

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492 participants in 3 patient groups

GSK372475 Arm

Experimental group

Description:

GSK372475 1.0- 1.5 mg/day

Treatment:

Drug: GSK372475

Paroxetine Arm

Experimental group

Description:

Paroxetine 20-30 mg/day

Treatment:

Drug: Paroxetine

Placebo

Other group

Description:

Placebo to Match

Treatment:

Other: Placebo