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
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in score on a Depression rating scale following 8 weeks of treatment.
- Secondary Outcome Measures
Name Time Method 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.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of GW679769 in treating Major Depressive Disorder (MDD)?
How does GW679769 compare to paroxetine in efficacy and safety for MDD patients?
Which biomarkers correlate with response to GW679769 in phase 2 trials for MDD?
What adverse events were observed in NCT00413023 and how were they managed?
Are there combination therapies involving GW679769 for treatment-resistant MDD?
Trial Locations
- Locations (1)
GSK Investigational Site
🇸🇪Solna, Sweden
GSK Investigational Site🇸🇪Solna, Sweden