MDD POC Study GSK372475 Subjects Depressive Disease

• Status: Completed
• Trial end date: 2008-10-15
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Paroxetine

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 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