Light-Therapy in the Treatment of the Acute Phase of the Bipolar Type II Depression (NCT00590265) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Light-Therapy in the Treatment of the Acute Phase of the Bipolar Type II Depression
Canada50 participantsStarted 2008-01
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of light therapy for the treatment of bipolar type II patients relapsing into a depressive phase during autumn or winter.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Bipolar type II disorder, depressive phase meeting DSM-IV criteria as per the SCID interview
* Hamilton Depression Rating Scale 21 items (HAMD-21) ≥ 17 and a Montgomery Asberg rating Scale (MADRS) ≥ 15 for at least 2 weeks and the episode has begun during the month of september or a later month
* Able to give their consent and willingness to participate to the study
Exclusion Criteria:
* Other psychiatric condition, organic brain disorder, unstable and/or untreated medical condition such as hypothyroidism, diabetes, cardiac condition, hypertension
* Deficit in vitamin B12 or folate
* Sub-syndromic hypomania symptoms as per a Young Mania Rating Scale (YMRS) score ≥ 4
* History of manic or hypomanic switch when exposed to bright light or during prolonged exposure to the sun during previous depressive phases
* Pregnancy or absence of a contraceptive treatment
* History of light-induced migraine or epilepsy
* Marked suicidal ideation
* Retinal blindness or severe cataract
* Glaucoma, retinal diseases of the eye
* Alcohol or drug abuse
* Known skin sensitivity to sunlight, especially in patients receiving photosensitizing drugs such as lithium or phenothiazines
* Past history of light therapy
What they're measuring
1
the response rate as defined by a 50% improvement of the depressive symptoms score on the MADRS scale