Bright Light Therapy in Seasonal Affective Disorder (SAD)
VAHAVA
Placebo-controlled, Double Blind RCT on the Efficacy of Bright Light Therapy in SAD
1 other identifier
interventional
60
1 country
1
Brief Summary
The aim of this study is to investigate the efficacy of bright light therapy in SAD. This is a placebo-controlled, double-blind randomized controlled trial (RCT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 10, 2009
CompletedFirst Posted
Study publicly available on registry
December 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedDecember 11, 2009
December 1, 2009
1.4 years
December 10, 2009
December 10, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Remission as defined by the SIGH-SAD
28 (visit window from 26 to 30 days) days after the inclusion day
Secondary Outcomes (1)
Decrease of the severity of symptoms as assessed by SIGH-SAD, Hamilton anxiety scale, and Beck depression inventory-21
28 (visit window from 26 to 30 days) days
Study Arms (2)
Bright light
EXPERIMENTALInactive "placebo-light"
PLACEBO COMPARATORInterventions
In this arm, patients will not get any bright-light therapy in a double-blind setting
Eligibility Criteria
You may qualify if:
- a patient has, according to the DSM-IV-TR, a Major depression, recurrent episode, seasonal pattern, "moderate" or "severe" (classification code 296.32 and 296.33)
- HAMD-21 (included in the SIGH-SAD) sum score is ≥ 22
- patient is over 18 years
- patient can read and understand the subject information sheet
- patient has signed the informed consent form
- patient is not pregnant
You may not qualify if:
- patient has a lifetime psychotic disorder
- patient has a DSM-IV Axis I disorder other than some anxiety disorder evaluated by MINI
- patient has some DSM-IV-TR Axis II disorder, which is likely to interfere with the study treatment according to the investigator
- patient has alcohol or some other substance use dependence or misuse
- life-time suicide attempt, or any thought of suicide during the last month
- patients has some unstable somatic disorder
- patient uses some medication on regular basis
- patient uses some herbal psychotropic agencies
- patient is, in the opinion of the investigator, unsuitable for any reason
- patient is a member of the site personnel or their immediate families
- patient has had bright light therapy during the current episode
- patient has some eye disease (patient can, however, be myopic or hyperopic)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oululead
- Oulu University Hospitalcollaborator
- ODL Terveys Oycollaborator
- Valkee Oycollaborator
- University of Eastern Finlandcollaborator
Study Sites (1)
Research unit, ODL Terveys Oy, Albertinkatu 18 A
Oulu, FIN-90100 Oulu, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 10, 2009
First Posted
December 11, 2009
Study Start
October 1, 2009
Primary Completion
March 1, 2011
Study Completion
April 1, 2011
Last Updated
December 11, 2009
Record last verified: 2009-12