Seasonal Affective Depression (SAD) Study
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ClinicalTrials.gov Identifier: NCT00069459 |
Recruitment Status
:
Completed
First Posted
: September 26, 2003
Last Update Posted
: September 25, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Depressive Disorder | Drug: Extended-release Bupropion Hydrochloride | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 250 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | September 23, 2003 |
Actual Primary Completion Date : | June 3, 2004 |
Actual Study Completion Date : | June 3, 2004 |
Arm | Intervention/treatment |
---|---|
Extended-release Bupropion Hydrochloride
Extended-release Bupropion Hydrochloride
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Drug: Extended-release Bupropion Hydrochloride
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
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- End of season depression-free rate. [ Time Frame: 7 months ]
- Time to onset of a seasonal depressive episode.Change from randomization on SIGH-SAD and HAMD-17. [ Time Frame: 7 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00069459

Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Additional Information:
Publications of Results:
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00069459 History of Changes |
Other Study ID Numbers: |
100006 |
First Posted: | September 26, 2003 Key Record Dates |
Last Update Posted: | September 25, 2017 |
Last Verified: | September 2017 |
Keywords provided by GlaxoSmithKline:
Winter depression, winter blues, depression, seasonal depression, seasonal affective disorder |
Additional relevant MeSH terms:
Depressive Disorder Depression Mood Disorders Seasonal Affective Disorder Mental Disorders Behavioral Symptoms Bupropion Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Physiological Effects of Drugs Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors |