Last updated: 11/04/2018 02:39:31
Prevention of Seasonal Affective Disorder
GSK study ID
398149
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Prevention of Seasonal Affective Disorder
Trial description: A Placebo Controlled Study Evaluating The Effectivess Of Medication In Preventing Seasonal Affective Disorder
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
Not applicable
Primary completion date:
2003-30-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Seasonal Affective Disorder (SAD)
Product
Compound N/A
Collaborators
Not applicable
Study date(s)
September 2002 to June 2003
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 99 Years
Accepts healthy volunteers
no
- (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.
- (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.
Inclusion and 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.
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Study complete
Actual primary completion date
2003-30-06
Actual study completion date
2003-30-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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