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 range
18 Years – 70 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the response rate as defined by a 50% improvement of the depressive symptoms score on the MADRS scale