At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 234 enrolled
Drug / intervention
bupropion hydrochloridedrug
Likely dose
Not stated in record
Key inclusion· 3
- ✓Diagnosed with major depressive disorder (DSM-IV-TR criteria) for the current episode lasting at least 8 weeks before screening
- ✓Must provide written informed consent (parents/proxy required if patient <20 years old)
- ✓Must have specified rating scores
Key exclusion· 9
- ✕Current or past history of seizure disorder or brain injury
- ✕Current or past history of anorexia or bulimia nervosa
- ✕History of manic episode
- ✕Past or current diagnosis of schizophrenia or other psychotic disorder
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Multi-Center, Phase II Study Evaluating the Safety and Efficacy of 323U66 SR in Patients With Depression
In Brief
A Phase 2 clinical trial evaluating bupropion hydrochloride for Depressive Disorder. Completed, enrolled 234 participants across 7 sites.
Detailed Summary
This study was designed to evaluate the efficacy and safety in major depressive disorder patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepressive Disorder
Countries, Japan
Collaborators--
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2004
First PostedAug 2005
Primary CompletionMay 2007
TodayJul 2026
First PostedAug 26, 2005
Enrollment StartDec 1, 2004
Primary CompletionMay 28, 2007
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 20.8 years ago
Interventions
bupropion hydrochloridedrug
Study drug