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
Location
GSK Clinical Trials Call Center
Lincoln, RI, United States, 02865-4208
Status
Study Complete
Location
GSK Clinical Trials Call Center
Cleveland, OH, United States, 44106
Status
Study Complete
Location
GSK Clinical Trials Call Center
Indianapolis, IN, United States, 45202
Status
Study Complete
Location
GSK Clinical Trials Call Center
New Haven, CT, United States, 06504-0605
Status
Study Complete
Location
GSK Clinical Trials Call Center
Philadelphia, PA, United States, 19106
Status
Study Complete
Location
GSK Clinical Trials Call Center
New York, NY, United States, 10021
Status
Study Complete
Location
GSK Clinical Trials Call Center
Toledo, OH, United States, 43623
Status
Study Complete
Location
GSK Clinical Trials Call Center
Libertyville, IL, United States, 60048
Status
Study Complete
Location
GSK Clinical Trials Call Center
West Allis, WI, United States, 53227
Status
Study Complete
Location
GSK Clinical Trials Call Center
Allentown, PA, United States, 18104
Status
Study Complete
Location
GSK Clinical Trials Call Center
Olean, NY, United States, 14760
Status
Study Complete
Location
GSK Clinical Trials Call Center
Milwaukee, WI, United States, 53226
Status
Study Complete
Location
GSK Clinical Trials Call Center
Florence, KY, United States, 41042
Status
Study Complete
Location
GSK Clinical Trials Call Center
Salem, OR, United States, 97309
Status
Study Complete
Location
GSK Clinical Trials Call Center
Wilmington, DE, United States, 19808-1251
Status
Study Complete
Location
GSK Clinical Trials Call Center
Northfield, IL, United States, 60093
Status
Study Complete
Location
GSK Clinical Trials Call Center
Staten Island, NY, United States, 10305
Status
Study Complete
Location
GSK Clinical Trials Call Center
Seattle, WA, United States, 98104
Status
Study Complete
Location
GSK Clinical Trials Call Center
Washington, DC, United States, 20016
Status
Study Complete
Location
GSK Clinical Trials Call Center
Madison, WI, United States, 53719
Status
Study Complete
Location
GSK Clinical Trials Call Center
Piscataway, NJ, United States, 08854
Status
Study Complete
Location
GSK Clinical Trials Call Center
Boise, ID, United States, 83704
Status
Study Complete
Location
GSK Clinical Trials Call Center
Royal Oak, MI, United States, 48067
Status
Study Complete
Location
GSK Clinical Trials Call Center
Lyndhurst, OH, United States, 44124
Status
Study Complete
Location
GSK Clinical Trials Call Center
Cincinnati, OH, United States, 45219
Status
Study Complete
Location
GSK Clinical Trials Call Center
Chicago, IL, United States, 60610
Status
Study Complete
Location
GSK Clinical Trials Call Center
Independence, OH, United States, 44131
Status
Study Complete
Location
GSK Clinical Trials Call Center
Portland, OR, United States, 97201
Status
Study Complete
Location
GSK Clinical Trials Call Center
Middleton, WI, United States, 53562
Status
Study Complete
Location
GSK Clinical Trials Call Center
Wellesley Hills, MA, United States, 02481
Status
Study Complete
Location
GSK Clinical Trials Call Center
Washington, DC, United States, 20037
Status
Study Complete
Location
GSK Clinical Trials Call Center
Chicago, IL, United States, 60631
Status
Study Complete
Location
GSK Clinical Trials Call Center
Mississauga, ON, Canada, L4W 1N2
Status
Study Complete
Location
GSK Clinical Trials Call Center
Cleveland, OH, United States, 44121
Status
Study Complete
Location
GSK Clinical Trials Call Center
Minneapolis, MN, United States, 55454
Status
Study Complete
Location
GSK Clinical Trials Call Center
Williamsville, NY, United States, 14221
Status
Study Complete
Location
GSK Clinical Trials Call Center
Okemos, MI, United States, 48864
Status
Study Complete
Location
GSK Clinical Trials Call Center
Greenwood, IN, United States, 46143
Status
Study Complete
Location
GSK Clinical Trials Call Center
Homer, AK, United States, 99603
Status
Study Complete
Location
GSK Clinical Trials Call Center
Newark, DE, United States, 19713
Status
Study Complete
Location
GSK Clinical Trials Call Center
Lawrence, NY, United States, 11559
Status
Study Complete
Location
GSK Clinical Trials Call Center
Chicago, IL, United States, 60612
Status
Study Complete
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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