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

Phase 2
Completed
Conditions
Depressive Disorder, Major
Registration Number
NCT00413023
Lead Sponsor
GlaxoSmithKline
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
348
Inclusion Criteria

Not provided

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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).
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change in score on a Depression rating scale following 8 weeks of treatment.
Secondary Outcome Measures
NameTimeMethod
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.

Trial Locations

Locations (1)

GSK Investigational Site

🇸🇪

Solna, Sweden

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