30-Minute Light Exposure for the Treatment of Seasonal Affective Disorder (NCT01462305) | Clinical Trial Compass
CompletedNot Applicable
30-Minute Light Exposure for the Treatment of Seasonal Affective Disorder
United States35 participantsStarted 2012-01-06
Plain-language summary
The primary objective of this study is to evaluate the effect of light therapy using a narrow 467nm light compared to a 580nm light in subjects with Seasonal Affective Disorder (SAD). It is hypothesized that the 467nm light will improve the symptoms of SAD better than the 580nm light.
Who can participate
Age range21 Years – 64 Years
SexALL
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Inclusion criteria
✓. Males and females, ages 21-64
✓. Able and willing to provide written informed consent
✓. History of recurrent major depressive episodes with winter-type seasonal pattern by Diagnostic and Statistical Manual of the American Psychiatric Associated, 4th Ed. (DSM-IV) criteria (American Psychiatric Association, 1990), based on diagnostic interview utilizing the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) (First et al., 2007)
✓. SIGH-ADS score of ≥20
✓. Use of the light device as instructed by the study clinician for at least 6 out of 7 days for the first two weeks of therapy and at least 5 out of 7 days for the remaining four weeks of therapy.
Exclusion criteria
✕. Participation in a study of investigational or marketed drugs or devices during the 30-day period prior to the start of the study or during the study
✕. Subjects who are medically complicated, medically unstable and/or have other severe diseases, as determined by the investigator.
✕. Abnormal TSH level, (outside range of 0.3 to 5.0 mlU/L), as determined by the TSH levels blood test
✕. History of concurrent psychiatric illness that would preclude compliance with the protocol and/or ability to complete the study safely
✕. History or current diagnosis of Bipolar I Disorder
. Variable psychiatric symptoms such as rapid cycling or severe premenstrual syndrome that could interfere with accurate assessment of the treatment effect
✕. History of a medical condition that affects mood or produces hallmark symptoms of a mood disorder (i.e. hypothyroidism)
✕. History of current or recent (within previous 12 months) alcohol, narcotic or other drug abuse by DSM-IV criteria