Light-Therapy in the Treatment of the Acute Phase of the Bipolar Type II Depression (BPII-DEP-LT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00590265|
Recruitment Status : Unknown
Verified July 2014 by Serge Beaulieu, Douglas Mental Health University Institute.
Recruitment status was: Recruiting
First Posted : January 10, 2008
Last Update Posted : July 29, 2014
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Type II Disorder Depression, Bipolar||Device: Northern Light Technology (SADelite lamp) bright light-therapy Device: Northern Light Technology (SADelite lamp) Dim light-therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||January 2008|
|Estimated Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||June 2015|
Device: Northern Light Technology (SADelite lamp) bright light-therapy
10 000 lux for 30 minutes
Other Name: Northern Light Technology (SADelite lamp) with two 36W bulbs
|Placebo Comparator: 2||
Device: Northern Light Technology (SADelite lamp) Dim light-therapy
<100 lux for 30 minutes
Other Name: Northern Light Technology (SADelite lamp) with two 18W bulbs + red filter (Medium Red 27 High Temperature treated, LEE Filters, Y = 3.64%)
- the response rate as defined by a 50% improvement of the depressive symptoms score on the MADRS scale [ Time Frame: 5 and 45 weeks ]
- the remission rate (MADRS scale ≤ 8 ) [ Time Frame: 5 and 45 weeks ]
- the relapse rate into depression or hypomania [ Time Frame: 5 and 45 weeks ]
- the sleep quality as per PSQI scale [ Time Frame: 5 and 45 weeks ]
- the quality of life as per SF-36 and Q-LES-Q SF scales [ Time Frame: 5 and 45 weeks ]
- the incidence of side-effects as per the UKU scale [ Time Frame: 5 and 45 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00590265
|Contact: Serge Beaulieu, Ph.D.||514-761-6131 ext firstname.lastname@example.org|
|Contact: Sybille Saury||514-761-6131 ext email@example.com|
|Douglas Mental Health University Institute||Recruiting|
|Montreal, Quebec, Canada, H4H 1R3|
|Contact: Sybille Saury 514-761-6131 ext 3330 firstname.lastname@example.org|
|Principal Investigator: Serge Beaulieu, M.D., Ph.D.|
|Principal Investigator:||Serge Beaulieu, Ph.D.||McGill University|