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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Douglas Mental Health University Institute
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Serge Beaulieu, Douglas Mental Health University Institute
ClinicalTrials.gov Identifier:
NCT00590265
First received: December 26, 2007
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Bipolar Type II Disorder
Depression, Bipolar
Device: Northern Light Technology (SADelite lamp) bright light-therapy
Device: Northern Light Technology (SADelite lamp) Dim light-therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Douglas Mental Health University Institute:

Primary Outcome Measures:
  • the response rate as defined by a 50% improvement of the depressive symptoms score on the MADRS scale [ Time Frame: 5 and 45 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the remission rate (MADRS scale ≤ 8 ) [ Time Frame: 5 and 45 weeks ] [ Designated as safety issue: No ]
  • the relapse rate into depression or hypomania [ Time Frame: 5 and 45 weeks ] [ Designated as safety issue: Yes ]
  • the sleep quality as per PSQI scale [ Time Frame: 5 and 45 weeks ] [ Designated as safety issue: No ]
  • the quality of life as per SF-36 and Q-LES-Q SF scales [ Time Frame: 5 and 45 weeks ] [ Designated as safety issue: No ]
  • the incidence of side-effects as per the UKU scale [ Time Frame: 5 and 45 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: January 2008
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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%)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590265

Contacts
Contact: Serge Beaulieu, Ph.D. 514-761-6131 ext 3301 serge.beaulieu@mcgill.ca
Contact: Sybille Saury 514-761-6131 ext 3330 sybille.saury@douglas.mcgill.ca

Locations
Canada, Quebec
Douglas Mental Health University Institute Recruiting
Montreal, Quebec, Canada, H4H 1R3
Contact: Sybille Saury    514-761-6131 ext 3330    sybille.saury@douglas.mcgill.ca   
Principal Investigator: Serge Beaulieu, M.D., Ph.D.         
Sponsors and Collaborators
Douglas Mental Health University Institute
National Alliance for Research on Schizophrenia and Depression
Investigators
Principal Investigator: Serge Beaulieu, Ph.D. McGill University
  More Information

Publications:
Kripke DF, mullaney DJ, Gillin JC, et al. Phototherapy of non-seasonal depression. In: Shagass C, Josiassen RC, Bridger WH, et al., eds. Biological Psychiatry. New York: Elsevier Science Publishing Co.; 1986:993-995
Lam RW, Levitt AJ, Kraus RP, et al. Management issues. In: ed.R.Lam and A.Levitt, ed. Canadian Consensus Guidelines for the Treatment of Seasonal Affective Disorder Clinical & Academic Publishing; 1999:96-114

Responsible Party: Serge Beaulieu, Douglas Mental Health University Institute
ClinicalTrials.gov Identifier: NCT00590265     History of Changes
Other Study ID Numbers: NARSAD-9818
Study First Received: December 26, 2007
Last Updated: July 28, 2014
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by Douglas Mental Health University Institute:
bipolar type II disorder
depression
remission
light-therapy
efficacy
safety

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Affective Disorders, Psychotic

ClinicalTrials.gov processed this record on October 19, 2014