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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 29 June 2015
Main ID:  NCT00046449
Date of registration: 30/09/2002
Prospective Registration: No
Primary sponsor: GlaxoSmithKline
Public title: Prevention of Seasonal Affective Disorder
Scientific title:
Date of first enrolment: September 2002
Target sample size:
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00046449
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Canada United States
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria: (Patient must meet these criteria in order to be eligible for this
study.)

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

Exclusion Criteria: (Patient cannot meet these criteria in order to be eligible for this
study.)

- Patient has a current or past history of seizure disorder or brain injury.

- Patient has a history or current diagnosis of anorexia nervousa 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Seasonal Affective Disorder (SAD)
Intervention(s)
Drug: Investigational Seasonal Affective Disorder (SAD) Drug
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
398149
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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