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

NCT00590265 | Active Not Recruiting DMC

• 1 other identifier: NARSAD-9818
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Type II Disorder; Depression, Bipolar

Keywords

bipolar type II disorder; depression; remission; light-therapy; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• the response rate as defined by a 50% improvement of the depressive symptoms score on the MADRS scale

  5 and 45 weeks

Secondary Outcomes (5)

• 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

Study Arms (2)

1

EXPERIMENTAL

Device: Northern Light Technology (SADelite lamp) bright light-therapy

2

PLACEBO COMPARATOR

Device: Northern Light Technology (SADelite lamp) Dim light-therapy

Interventions

Northern Light Technology (SADelite lamp) bright light-therapy DEVICE

10 000 lux for 30 minutes

Also known as: Northern Light Technology (SADelite lamp) with two 36W bulbs

1

Northern Light Technology (SADelite lamp) Dim light-therapy DEVICE

\<100 lux for 30 minutes

Also known as: Northern Light Technology (SADelite lamp) with two 18W bulbs + red filter (Medium Red 27 High Temperature treated, LEE Filters, Y = 3.64%)

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Douglas Mental Health University Institute: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

Douglas Mental Health University Institute

Montreal, Quebec, H4H 1R3, Canada

Location

Related Publications (23)

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MeSH Terms

Conditions

Bipolar Disorder; Depression

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Officials

• Serge Beaulieu, Ph.D.

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Serge Beaulieu

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 10, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

CA (1)