At a glance
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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
In Brief
A Phase 3 clinical trial evaluating 323U66 (Bupropion Hydrochloride Sustained Release) and Placebo for Depressive Disorder. Completed, enrolled 325 participants across 62 sites.
Detailed Summary
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).
Study Details
Timeline
Interventions
Subjects with Major Depressive Disorder who were randomized to take 100mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100mg dose of Bupropion morning and evening. Weeks 3 thru 12 received 150mg dose morning and evening. Week 1=dose level 1, 100 mg. Week 2=dose level 2, 200 mg. Weeks 3 - 12=dose level 3, 300 mg.
Subjects with Major Depressive Disorder who were randomised to placebo to match Bupropion SR during the treatment period.