Light-Therapy in the Treatment of the Acute Phase of the Bipolar Type II Depression

Study Overview
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Brief Summary
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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.

Detailed Description
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Bipolar type II depression is a very frequent condition for which we still have a significant lack of acute treatments. There is now consistent evidence that light-therapy treatment produced a significant decrease of depressive symptoms for seasonal and non-seasonal unipolar depression. But there are no long-term studies of light therapy for the treatment of non-seasonal unipolar depression. It is also important to note that many of these studies involved co-therapy with antidepressant drugs or sleep-deprivation, making the interpretation of the results even more difficult. Therefore, we propose to study the efficacy and safety of light therapy for the treatment of bipolar type II patients relapsing into a depressive phase during the period of September to mid-March. This will be a double-blind randomized placebo-controlled study. Bipolar II out-patients will be recruited from our bipolar disorders program and from our 5 general psychiatry out-patient clinics. We will recruit bipolar type II patients facing a depressive phase and after they give their informed consent and we had verified they meet all inclusion and exclusion criteria, they will be randomized blindly to Bright-light (10 000 lux) vs Dim-light placebo (100 lux) therapies. Both, patient and investigator/rater will be blind to the type of light treatment assigned to the patient. The light therapy will take place during 30 minutes daily in the morning AFTER the usual awakening time of the patient in order to avoid even partial sleep deprivation which would confound the results if we were to observe a greater switch rate into mania or hypomania. Reasons for study termination can be serious side-effects, development of suicidal ideations or hypomanic/manic symptoms, patient's own decision, or any other of the exclusion criteria being fulfilled during the course of the study. Depressive and manic/hypomanic symptoms, quality of life, sleep quality and side-effects will be assessed at baseline and during the study. Biological parameters will also be measured along the study. We think that this study will allow us to determine the efficacy and safety of a 5 weeks bright light therapy for Bipolar type II depression and provide open label data as to the long term benefits of this treatment if prolonged over 5 weeks during the dark months of the year.

Official Title
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Light-Therapy in the Treatment of the Acute Phase of the Bipolar Type II Depression: Double-Blind, Placebo-Controlled Study to Establish Efficacy and Safety

Conditions
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Bipolar Type II Disorder, Depression, Bipolar

Intervention / Treatment
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* Device: Northern Light Technology (SADelite lamp) bright light-therapy
* Device: Northern Light Technology (SADelite lamp) Dim light-therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: Northern Light Technology (SADelite lamp) bright light-therapy<br>* 10 000 lux for 30 minutes<br>* Other names: Northern Light Technology (SADelite lamp) with two 36W bulbs;|
| Placebo Comparator: 2<br> | Device: Northern Light Technology (SADelite lamp) Dim light-therapy<br>* <100 lux for 30 minutes<br>* Other names: Northern Light Technology (SADelite lamp) with two 18W bulbs + red filter (Medium Red 27 High Temperature treated, LEE Filters, Y = 3.64%);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the response rate as defined by a 50% improvement of the depressive symptoms score on the MADRS scale |  | 5 and 45 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the remission rate (MADRS scale ≤ 8 ) |  | 5 and 45 weeks | 
| the relapse rate into depression or hypomania |  | 5 and 45 weeks | 
| the sleep quality as per PSQI scale |  | 5 and 45 weeks | 
| the quality of life as per SF-36 and Q-LES-Q SF scales |  | 5 and 45 weeks | 
| the incidence of side-effects as per the UKU scale |  | 5 and 45 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bipolar type II disorder, depression, remission, light-therapy, efficacy, safety