NCT00046241|CompletedPhase 3

Prevention of Seasonal Affective Disorder

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

GlaxoSmithKline ClinicalTrials.gov

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1 other identifier

AK130930

Study Type

interventional

Target

300

Locations

2 countries

Sites

Timeline

RegisteredSep 2002

StartedSep 2002

CompletionJun 2003

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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

300

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Sep 2002

Shorter than P25 for phase_3

Geographic Reach

2 countries

51 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9 months study duration

Study Start

First participant enrolled

September 1, 2002

Completed

23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2002

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2002

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed

Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

9 months

First QC Date

September 24, 2002

Last Update Submit

January 20, 2017

Conditions

Seasonal Affective Disorder

Keywords

seasonal depression winter blues winter depression

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Extended-release bupropion hydrochlorideDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patient has a history of Major Depressive Disorder (MDD) with a seasonal pattern.

You may not qualify if:

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.

Contact the study team to confirm eligibility.