NCT00590265

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Douglas Mental Health University Institute · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Bipolar Type II Disorder
• Depression, Bipolar

Interventions

Type	Name	Description
DEVICE	Northern Light Technology (SADelite lamp) bright light-therapy	10 000 lux for 30 minutes
DEVICE	Northern Light Technology (SADelite lamp) Dim light-therapy	\<100 lux for 30 minutes

Timeline

• Start date: 2008-01-01
• Primary completion: 2025-06-01
• Completion: 2026-08-01
• First posted: 2008-01-10
• Last updated: 2024-08-07

Locations

1 site across 1 country: Canada