NCT00048204
Completed
Phase 2
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
ConditionsDepressive Disorder, Major
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Depressive Disorder, Major
- Sponsor
- GlaxoSmithKline
- Enrollment
- 372
- Primary Endpoint
- Hamilton Depression Rating Scale
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
A Placebo Controlled Study Evaluating Efficacy And Safety of Medication In Patients With Major Depressive Disorder (MDD)
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Hamilton Depression Rating Scale
Time Frame: 8 Weeks
Secondary Outcomes
- Hamilton Depression Rating Scale Clinical Global Impression-Global Improvement Clinical Global Impression-Severity of Illness Hospital Anxiety and Depression Scale(8 Weeks)
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