Last updated: 11/26/2018 16:20:12
Seasonal Affective Disorder Prevention
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A 7 Month, Multicenter, Randomized, Double-blind, Placebo-Controlled Comparison of 150-300 mg/day of Extended-release Bupropion Hydrochloride and Placebo for the Prevention of Seasonal Affective Disorder in subjects with a History of Seasonal Affective Disorder Followed by an 8-week Observational Follow-up Phase
Trial description: This is a placebo-controlled study evaluating the effectiveness of medication in preventing seasonal affective disorder.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
300
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Modell JG, Rosenthal NE, Harriett AE, Krishen A, Asgharian A, Foster VJ, Metz A, Rockett CB, Wightman DS. Seasonal affective disorder and its prevention by anticipatory treatment with bupropion XL. Biol Psychiatry. 2005 Oct 15;58(8):658-67. doi: 10.1016/j.biopsych.2005.07.021. PMID:16271314
Modell, JG, Rosenthal NE. Once-Daily Bupropion XL for the prevention of seasonal major depressive episodes. 43rd Annual Meeting of the American College of Neuropsychopharmacology, San Juan, Puerto Rico, 12-16 December, 2004.
Medical condition
Seasonal Affective Disorder
Product
bupropion
Collaborators
None
Study date(s)
September 2002 to June 2003
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Patient has a history of Major Depressive Disorder (MDD) with a seasonal pattern.
- Patient has a current or past history of seizure disorder or brain injury.
- Patient has a history or current diagnosis of anorexia nervosa or bulimia.
Inclusion and exclusion criteria
Inclusion criteria:
- Patient has a history of Major Depressive Disorder (MDD) with a seasonal pattern.
Exclusion criteria:
- Patient has a current or past history of seizure disorder or brain injury.
- Patient has a history or current diagnosis of anorexia nervosa or bulimia.
- Patient has recurrent summer depression more frequently than winter depression.
- Patient has primary diagnosis of panic disorder, Obsessive Compulsive Disorder (OCD), Posttraumatic Stress Disorder (PTSD), acute distress disorder, bipolar II disorder or other psychotic disorders.
- Patient has initiated psychotherapy within the last 3 months.
Trial location(s)
Location
GSK Clinical Trials Call Center
Hoffman Estates, IL, United States, 60194
Status
Study Complete
Location
GSK Clinical Trials Call Center
Eugene, OR, United States, 97401
Status
Study Complete
Location
GSK Clinical Trials Call Center
Philadelphia, PA, United States, 19107
Status
Study Complete
Location
GSK Clinical Trials Call Center
Moorestown, NJ, United States, 08057
Status
Study Complete
Location
GSK Clinical Trials Call Center
Portland, OR, United States, 97209
Status
Study Complete
Location
GSK Clinical Trials Call Center
Amityville, NY, United States, 11701
Status
Study Complete
Showing 1 - 6 of 54 Results
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2003-06-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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