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Seasonal Affective Depression (SAD) Study

NCT ID: NCT00069459

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-23

Study Completion Date

2004-06-03

Brief Summary

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

Detailed Description

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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

Conditions

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Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Extended-release Bupropion Hydrochloride

Extended-release Bupropion Hydrochloride

Group Type OTHER

Extended-release Bupropion Hydrochloride

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Anchorage, Alaska, United States

Site Status

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Hamden, Connecticut, United States

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Newark, Delaware, United States

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Wilmington, Delaware, United States

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Washington D.C., District of Columbia, United States

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Boise, Idaho, United States

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Edwardsville, Illinois, United States

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Hoffman Estates, Illinois, United States

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Northfield, Illinois, United States

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Oak Brook, Illinois, United States

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Oakbrook Terrace, Illinois, United States

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Cedar Rapids, Iowa, United States

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Overland Park, Kansas, United States

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Baltimore, Maryland, United States

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Rockville, Maryland, United States

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Belmont, Massachusetts, United States

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Farmington Hills, Michigan, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Kenilworth, New Jersey, United States

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Moorestown, New Jersey, United States

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Piscataway, New Jersey, United States

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Princeton, New Jersey, United States

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Albany, New York, United States

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Lawrence, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Lyndhurst, Ohio, United States

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Toledo, Ohio, United States

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Eugene, Oregon, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Allentown, Pennsylvania, United States

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Havertown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Lincoln, Rhode Island, United States

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Woodstock, Vermont, United States

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Spokane, Washington, United States

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Brown Deer, Wisconsin, United States

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Madison, Wisconsin, United States

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Menomonee Falls, Wisconsin, United States

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Middleton, Wisconsin, United States

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Countries

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United States

References

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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.

Reference Type RESULT

Other Identifiers

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100006

Identifier Type: -

Identifier Source: org_study_id