Prevention of Seasonal Affective Disorder

Phase 3

Completed

• Conditions: Seasonal Affective Disorder

• Registration Number: NCT00046241
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2002-09-24
• Study First Submitted QC: 2002-09-24
• Study First Posted: 2002-09-25
• Primary Completion: 2003-06
• Study Completion: 2003-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-20
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in HAMD-24 and -17 total score. Change in pain score.

Trial Locations

Locations (1)

GSK Clinical Trials Call Center; 🇨🇦 Sherbrooke, Quebec, Canada