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Prevention of Seasonal Affective Disorder

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ClinicalTrials.gov Identifier: NCT00046241
Recruitment Status : Completed
First Posted : September 25, 2002
Last Update Posted : January 23, 2017
Sponsor:
Information provided by:

Study Description
Brief Summary:
This is a placebo controlled study evaluating the effectiveness of medication in preventing depressive episodes in subjects with a history of Seasonal Affective Disorder (SAD).

Condition or disease Intervention/treatment Phase
Seasonal Affective Disorder Drug: Extended-release bupropion hydrochloride Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A 7 Month, Multicenter, Randomized, Double-blind, Placebo-controlled Comparison of 150-300mg/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
Actual Study Start Date : September 2002
Primary Completion Date : June 2003
Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Time between randomization and onset of a seasonal depressive episode. Proportion of depression-free subjects.

Secondary Outcome Measures :
  1. Change in HAMD-24 and -17 total score. Change in pain score.

Eligibility Criteria

Information from the National Library of Medicine

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

Information from the National Library of Medicine

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): NCT00046241


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Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trial, MD GlaxoSmithKline
More Information

ClinicalTrials.gov Identifier: NCT00046241     History of Changes
Other Study ID Numbers: AK130930
First Posted: September 25, 2002    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017

Keywords provided by GlaxoSmithKline:
seasonal depression winter blues winter depression

Additional relevant MeSH terms:
Disease
Mood Disorders
Seasonal Affective Disorder
Pathologic Processes
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