A Study Of A New Medicine (GW597599B) For The Treatment Of Major Depressive Disorder

An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Fixed-Dose Study Comparing the Efficacy and Safety of GW597599B or Paroxetine to Placebo in Moderately to Severely Depressed Patients With Major Depressive Disorder

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00048204

Enrollment

372

Registered

2002-10-30

Start date

2002-11-04

Completion date

2003-09-30

Last updated

2017-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder, Major

Keywords

Depression, Psychiatry, Major Depressive Disorder

Brief summary

A Placebo Controlled Study Evaluating Efficacy And Safety of Medication In Patients With Major Depressive Disorder (MDD)

Interventions

DRUGGW597599B

DRUGparoxetine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Patients meet the diagnosis of Major Depressive Disorder (MDD).

Exclusion criteria

* Patients with a primary diagnosis other than MDD. * Patients with a history of schizophrenia, schizoaffective disorders, seizure disorders or bipolar affective disorder. * Patients receiving formal psychotherapy or cognitive/behavioral therapy concurrently or in the 12 weeks prior to screening visit. * Patient is actively suicidal. * Patients who have a history of migraine headaches.

Design outcomes

Primary

Measure	Time frame
Hamilton Depression Rating Scale	8 Weeks

Secondary

Measure	Time frame
Hamilton Depression Rating Scale Clinical Global Impression-Global Improvement Clinical Global Impression-Severity of Illness Hospital Anxiety and Depression Scale	8 Weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026