Prevention of Seasonal Affective Disorder - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00046241

Purpose

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	Intervention	Phase
Seasonal Affective Disorder	Drug: Extended-release bupropion hydrochloride	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Depression Seasonal Affective Disorder

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Time between randomization and onset of a seasonal depressive episode. Proportion of depression-free subjects.

Secondary Outcome Measures:

Change in HAMD-24 and -17 total score. Change in pain score.

Estimated Enrollment:	300
Study Start Date:	September 2002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046241

Show 54 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trial, MD

GlaxoSmithKline

More Information

No publications provided

Study ID Numbers:	AK130930
Study First Received:	September 24, 2002
Last Updated:	March 6, 2006
ClinicalTrials.gov Identifier:	NCT00046241 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

seasonal depression winter blues winter depression

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder
Pharmacologic Actions
Seasonal Affective Disorder

Pathologic Processes
Mental Disorders
Therapeutic Uses
Bupropion
Mood Disorders
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 09, 2009