Seasonal Affective Depression (SAD) Study
Phase 1
Completed
- Conditions
- Depressive Disorder
- Interventions
- Registration Number
- NCT00069459
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
A placebo controlled study evaluating the effectiveness of medication in preventing winter depressive episodes in patients with a history of Seasonal Affective Disorder
- Detailed Description
A 7-Month Multicenter, Parallel, Double-Blind, Placebo-Controlled Comparison of 150-300mg/day of Extended-release Bupropion Hydrochloride and Placebo for the Prevention of Seasonal Depressive Episodes in Subjects with a History of Seasonal Affective Disorder Followed by an 8-week Observational Follow-up Phase
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
Inclusion Criteria
- History of Major Depressive Disorder (MDD) with a seasonal pattern.
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Exclusion Criteria
- Current or past history of seizure disorder or brain injury.
- History or current diagnosis of anorexia nervosa or bulimia.
- Recurrent summer depression more frequently than winter depression.
- Primary diagnosis of panic disorder, Obsessive Compulsive Disorder (OCD), Post-traumatic Stress Disorder(PTSD), acute distress disorder, bipolar II disorder or other psychotic disorders.
- Initiated psychotherapy within the last 3 months.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Extended-release Bupropion Hydrochloride Extended-release Bupropion Hydrochloride Extended-release Bupropion Hydrochloride
- Primary Outcome Measures
Name Time Method End of season depression-free rate. 7 months
- Secondary Outcome Measures
Name Time Method Time to onset of a seasonal depressive episode.Change from randomization on SIGH-SAD and HAMD-17. 7 months
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Middleton, Wisconsin, United States