Light-Therapy in the Treatment of the Acute Phase of the Bipolar Type II Depression (BPII-DEP-LT)

February 17, 2023 updated by: Serge Beaulieu, Douglas Mental Health University Institute

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4H 1R3
        • Douglas Mental Health University Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Device: Northern Light Technology (SADelite lamp) bright light-therapy
10 000 lux for 30 minutes
Other Names:
  • 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 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?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Douglas Mental Health University Institute

Collaborators

National Alliance for Research on Schizophrenia and Depression

Investigators

  • Principal Investigator: Serge Beaulieu, Ph.D., McGill University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Anticipated)

June 1, 2025

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

December 26, 2007

First Posted (Estimate)

January 10, 2008

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 17, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NARSAD-9818

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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