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

NCT ID: NCT00048204

Last Updated: 2017-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

372 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-04

Study Completion Date

2003-09-30

Brief Summary

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

Detailed Description

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Conditions

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Depressive Disorder, Major

Keywords

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Depression Psychiatry Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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GW597599B

Intervention Type DRUG

paroxetine

Intervention Type DRUG

Other Intervention Names

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GW597599B

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Countries

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Canada United States

Study Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Clinical Study Report

View Document

Document Type: Dataset Specification

View Document

Document Type: Study Protocol

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

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NKD20006

Identifier Type: -

Identifier Source: org_study_id