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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Venlafaxine Hydrochloride

Criteria

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