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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00296517 |
This study is designed to evaluate the efficacy and safety in depressive patients who did not respond sufficiently to selective serotonin re-uptake inhibitors (SSRI).
Condition | Intervention | Phase |
---|---|---|
Major Depressive Disorder (MDD) |
Drug: 323U66 (bupropion hydrochloride) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Clinical Evaluation of 323U66 SR in Patients With Depression - Placebo-Controlled, Double-Blind, Comparative Study in Patients With Depression Who Did Not Respond Sufficiently to Selective Serotonin re-Uptake Inhibitors |
Estimated Enrollment: | 300 |
Study Start Date: | January 2006 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
[At the end of the pretreatment phase]
[At the start of the treatment phase]
Exclusion Criteria:
[At the start of the pre-treatment phase]
[At the start of the treatment phase]
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | AK1102365 |
Study First Received: | February 23, 2006 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00296517 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
bupropion hydrochloride SSRI non-responder depression |
placebo-controlled double-blind comparative study |
Dopamine Depression Mental Disorders Bupropion Mood Disorders |
Depressive Disorder, Major Depressive Disorder Serotonin Behavioral Symptoms |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Dopamine Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Pharmacologic Actions Antidepressive Agents |