Bright Light Therapy in Seasonal Affective Disorder (SAD) (VAHAVA)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by University of Oulu.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Oulu
Collaborators:
Oulu University Hospital
ODL Terveys Oy
Valkee Oy
University of Eastern Finland
Information provided by:
University of Oulu
ClinicalTrials.gov Identifier:
NCT01030276
First received: December 10, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Seasonal Affective Disorder |
Other: Bright light therapy Other: Inactive "placebo-light" |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Placebo-controlled, Double Blind RCT on the Efficacy of Bright Light Therapy in SAD |
Resource links provided by NLM:
Further study details as provided by University of Oulu:
Primary Outcome Measures:
- Remission as defined by the SIGH-SAD [ Time Frame: 28 (visit window from 26 to 30 days) days after the inclusion day ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Decrease of the severity of symptoms as assessed by SIGH-SAD, Hamilton anxiety scale, and Beck depression inventory-21 [ Time Frame: 28 (visit window from 26 to 30 days) days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | April 2011 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Bright light |
Other: Bright light therapy
Bright light therapy
|
| Placebo Comparator: Inactive "placebo-light" |
Other: Inactive "placebo-light"
In this arm, patients will not get any bright-light therapy in a double-blind setting
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030276
Contacts
| Contact: Markku J Timonen, Prof | +358 40 8324883 | markku.timonen@oulu.fi |
Locations
| Finland | |
| Research unit, ODL Terveys Oy, Albertinkatu 18 A | Recruiting |
| Oulu, Finland, FIN-90100 Oulu | |
| Contact: Markku J Timonen, Prof + 358 40 8324883 markku.timonen@oulu.fi | |
Sponsors and Collaborators
University of Oulu
Oulu University Hospital
ODL Terveys Oy
Valkee Oy
University of Eastern Finland
More Information
No publications provided
| Responsible Party: | Osmo Tervonen, professor of Radiology, Institute of Diagnostics (Radiology), University of Oulu, Box 5000, FIN-90014 University of Oulu, Finland |
| ClinicalTrials.gov Identifier: | NCT01030276 History of Changes |
| Other Study ID Numbers: | FI (FWA00000190) 11/2008 |
| Study First Received: | December 10, 2009 |
| Last Updated: | December 10, 2009 |
| Health Authority: | Finland: Ethics Committee |
Additional relevant MeSH terms:
|
Seasonal Affective Disorder Mood Disorders Depressive Disorder Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013