Seasonal Affective Depression (SAD) Study

Study Description

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Brief Summary:

A placebo controlled study evaluating the effectiveness of medication in preventing winter depressive episodes in patients with a history of Seasonal Affective Disorder

Condition or disease	Intervention/treatment	Phase
Depressive Disorder	Drug: Extended-release Bupropion Hydrochloride	Phase 1

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	250 participants
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
Actual Study Start Date :	September 23, 2003
Actual Primary Completion Date :	June 3, 2004
Actual Study Completion Date :	June 3, 2004

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. End of season depression-free rate. [ Time Frame: 7 months ]

Secondary Outcome Measures :

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

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 48 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Results for study 100006 can be found on the GSK Clinical Study Register. 

Publications of Results:

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 Posted:	September 26, 2003
Last Update Posted:	September 25, 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