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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
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
A placebo controlled study evaluating the effectiveness of medication in preventing winter depressive episodes in patients with a history of Seasonal Affective Disorder

Condition or disease Intervention/treatment Phase
Depressive Disorder Drug: Extended-release Bupropion Hydrochloride Phase 1

Detailed Description:
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

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Extended-release Bupropion Hydrochloride
Extended-release Bupropion Hydrochloride
 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


Outcome Measures
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Primary Outcome Measures :
  1. End of season depression-free rate. [ Time Frame: 7 months ]

Secondary Outcome Measures :
  1. Time to onset of a seasonal depressive episode.Change from randomization on SIGH-SAD and HAMD-17. [ Time Frame: 7 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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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): NCT00069459


  Show 48 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Additional Information:
Results for study 100006 can be found on the GSK Clinical Study Register.  This link exits the ClinicalTrials.gov site

Publications of Results:
Modell, JG, Rosenthal NE. Once-Daily Bupropion XL for the prevention of seasonal major depressive episodes. 43nd Annual Meeting of the American College of Neuropsychopharmacology, San Juan, Puerto Rico, 12-16 December, 2004.

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