Seasonal Affective Depression (SAD) Study

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00069459
First received: September 25, 2003
Last updated: February 13, 2013
Last verified: February 2013
  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
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)
Intervention Details:
    Drug: Extended-release Bupropion Hydrochloride
    Other Name: Extended-release 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT00069459

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

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov 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:
Depression
Seasonal Affective Disorder
Mood Disorders
Behavioral Symptoms
Depressive Disorder
Mental Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014