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Seasonal Affective Depression (SAD) Study
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00069459
First received: September 25, 2003
Last updated: February 6, 2017
Last verified: February 2017
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Purpose
A placebo controlled study evaluating the effectiveness of medication in preventing winter depressive episodes in patients with a history of Seasonal Affective Disorder
| Condition | Intervention | Phase |
|---|---|---|
| Seasonal Affective Disorder (SAD) | Drug: Extended-release Bupropion Hydrochloride | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (masked roles unspecified) 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 |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- End of season depression-free rate.
Secondary Outcome Measures:
- Time to onset of a seasonal depressive episode. Change from randomization on SIGH-SAD and HAMD-17.
| Estimated Enrollment: | 250 |
| Study Start Date: | September 2003 |
| Study Completion Date: | June 2004 |
| Primary Completion Date: | June 2004 (Final data collection date for primary outcome measure) |
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
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00069459
Show 47 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00069459
Show 47 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00069459 History of Changes |
| Other Study ID Numbers: |
100006 |
| Study First Received: | September 25, 2003 |
| Last Updated: | February 6, 2017 |
Keywords provided by GlaxoSmithKline:
|
Winter depression, winter blues, depression, seasonal depression, seasonal affective disorder |
Additional relevant MeSH terms:
|
Mood Disorders Seasonal Affective Disorder Mental Disorders Depressive Disorder 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 |
ClinicalTrials.gov processed this record on June 22, 2017