Seasonal Affective Depression (SAD) Study

Study Overview
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Brief Summary
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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
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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

Official Title
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A 7 Month, Multicenter, Parallel, Double-Blind, Placebo-Controlled Comparison of 150-300 mg/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

Conditions
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Depressive Disorder

Intervention / Treatment
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* Drug: Extended-release Bupropion Hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of Major Depressive Disorder (MDD) with a seasonal pattern. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Extended-release Bupropion Hydrochloride<br>Extended-release Bupropion Hydrochloride | Drug: Extended-release Bupropion Hydrochloride<br>* Bupropion hydrochloride will be available in dose strength of 150 and 300 milligram (mg). Subjects will receive one tablet of 150 mg bupropion hydrochloride from Day 1 to 7, from Day 8 to Week 27 will receive one tablet of 300 mg bupropion hydrochloride and from Week 28-29 one tablet of bupropion hydrochloride<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End of season depression-free rate. |  | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to onset of a seasonal depressive episode.Change from randomization on SIGH-SAD and HAMD-17. |  | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Winter depression, winter blues, depression, seasonal depression, seasonal affective disorder