MDD POC Study GSK372475 Subjects Depressive Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

492 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-19

Study Completion Date

2008-10-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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GSK372475 Arm

GSK372475 1.0- 1.5 mg/day

Group Type EXPERIMENTAL

GSK372475

Intervention Type DRUG

GSK372475 1.0-1.5 mg/day

Paroxetine Arm

Paroxetine 20-30 mg/day

Group Type EXPERIMENTAL

Paroxetine

Intervention Type DRUG

Paroxetine 20-30 mg/day

Placebo

Placebo to Match

Group Type OTHER

Placebo

Intervention Type OTHER

Placebo to Match

Interventions

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GSK372475

GSK372475 1.0-1.5 mg/day

Intervention Type DRUG

Paroxetine

Paroxetine 20-30 mg/day

Intervention Type DRUG

Placebo

Placebo to Match

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No