Prevention of Seasonal Affective Disorder

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).

Completed

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Key information

Conditions

Seasonal Affective Disorder Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Clinical Trials Call Center, Calgary, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extended-release Bupropion Hydrochloride

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start: 2002
Primary completion: 2003
Study completion: 2003
First posted: Sep 25, 2002
Registry last updated: Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed