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

History of Changes

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:

MedlinePlus related topics: Mood Disorders Seasonal Affective Disorder

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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


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:


Mood Disorders Seasonal Affective Disorder Mental Disorders Depressive Disorder 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

ClinicalTrials.gov processed this record on September 30, 2016

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