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Seasonal Affective Depression (SAD) Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00069459
First Posted: September 26, 2003
Last Update Posted: September 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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
Depressive Disorder Drug: Extended-release Bupropion Hydrochloride Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

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

Enrollment: 250
Actual Study Start Date: September 23, 2003
Study Completion Date: June 3, 2004
Primary Completion Date: June 3, 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

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:

  • 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
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

Additional Information:
Publications:
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 Submitted: September 25, 2003
First Posted: September 26, 2003
Last Update Posted: September 22, 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