Study Of The Effects Of A New Antidepressant Therapy In Patients With Major Depressive Disorder (MDD)

A Randomised, Double-Blind, Double-Dummy, Parallel-Group, Placebo-Controlled, Forced Dose Titration Study Evaluating the Efficacy and Safety of GW679769 and Paroxetine in Subjects With Major Depressive Disorder (MDD)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00413023

Enrollment

348

Registered

2006-12-19

Start date

2005-06-30

Completion date

2006-09-30

Last updated

2016-10-28

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, major depressive disorder, MDD

Brief summary

The purpose of this study is to assess the efficacy, safety and tolerability of GW679769 patients with Major depressive Disorder (MDD).

Interventions

DRUGGW679769

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Inclusion criteria

* Primary diagnosis of Major depressive Disorder as defined in DSM-IV. * Capable of giving informed consent and willing to comply with the study requirements. * Women of childbearing potential must agree to one of a number of defined acceptable methods of birth control.

Exclusion criteria

* Primary diagnosis within the past 6 months of another Axis 1 disorder such as an anxiety disorder. * Use of medications for a psychiatric condition including herbals in the past 2-12 weeks according to medication type. * Subjects who, in the investigator's judgement, pose a current, serious suicidal or homicidal risk or have made a suicide attempt within the past 6 months. * Subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance abuse or subjects who currently meet or who met within 6 months prior to screening DSM-IV criteria for substance dependence (other than nicotine). * Significantly abnormal blood or urine laboratory tests or electrocardiogram (ECG).

Design outcomes

Primary

Measure	Time frame
Change in score on a Depression rating scale following 8 weeks of treatment.	—

Secondary

Measure	Time frame
Change in score on a number of rating scales following 8 weeks of treatment assessing symptomatic, behavioural and functional parameters which together provide a more complete description of the disorder.	—

Countries

Argentina, Belgium, Chile, Costa Rica, Germany, Italy, Peru, Poland, Slovakia, Spain, Sweden

Outcome results

None listed

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