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Seasonal Affective Depression (SAD) Study

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: September 25, 2003
Last updated: February 13, 2013
Last verified: February 2013
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: See Detailed Description

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)
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00069459

  Show 47 Study Locations
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Responsible Party: Study Director, GSK Identifier: NCT00069459     History of Changes
Other Study ID Numbers: 100006 
Study First Received: September 25, 2003
Last Updated: February 13, 2013
Health Authority: United States: Food and Drug Administration

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
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 processed this record on December 08, 2016