Adjunctive Bright Light Therapy in Patients With Bipolar Depression and Eveningness
NCT ID: NCT05357313
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2022-06-02
2026-02-28
Brief Summary
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Detailed Description
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Method: Each eligible participant will be randomized to either i) bright light therapy (BLT) or ii) inactive negative ion generator (placebo) treatment for 30-minutes daily at their habitual wake time for a total of six weeks. Participants will be evaluated at baseline, 2nd, 4th and 6th week for depression and insomnia symptoms. Actigraphy will be done at baseline and in the last week of treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Bright light therapy group
10,000lux bright light
Bright light therapy
Exposure to 10,000lux bright light for 30minutes a day for six weeks
Placebo group
inactive negative ion generator
Inactive negative ion generator
Exposure to an inactive negative ion generator for 30 minutes a day for six weeks
Interventions
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Bright light therapy
Exposure to 10,000lux bright light for 30minutes a day for six weeks
Inactive negative ion generator
Exposure to an inactive negative ion generator for 30 minutes a day for six weeks
Eligibility Criteria
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Inclusion Criteria
2. Is capable to give informed consent.
3. Meeting the diagnostic criteria of bipolar depression (including both bipolar I and II disorders) by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V), Disorders (SCID-V).
4. a score 20 or above representing current moderate or severe episode of major depression and a score of at least 1 on items H1 or H2 on the Structured Interview Guide for the Hamilton Depression Rating Scale with Atypical Depression Supplement (SIGH-ADS), corresponding to at least moderate severity.
5. A score of 41 or less by the Morningness-Eveningness Questionnaire which represents eveningness.
6. On a stable dose of antimanic treatment for bipolar disorder for at least four weeks.
Exclusion Criteria
2. A past history of rapid-cycling within the past twelve months or a Young Mania Rating Scale more than 12 at screening
3. A current or past history of schizophrenia, mental retardation, organic mental disorder; or current substance use disorder.
4. Presence of psychotic symptoms or substantial suicidal risk as judged by the clinician and/or screening instruments.
5. Presence of contraindications to bright light therapy: for example, history of light induced migraine/ epilepsy; current use of photosensitizing medications such as St. John's wart; presence of eye disease: e.g. retinal blindness, severe cataract, glaucoma, and photosensitive skin condition e.g. systemic lupus erythematosus
6. Significant medical condition/ hearing impairment/ speech deficit leading to incapability of completing clinical interview.
7. Regular shift-workers or trans-meridian flight in the past 3 months or during study
8. Enrolment in another clinical trial of an investigational medicinal product or device.
9. Receiving regular psychotherapy.
18 Years
65 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Joey WY Chan
Clinical Associate Professor
Locations
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The Chinese University of Hong Kong
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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14111502
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2020.676T
Identifier Type: -
Identifier Source: org_study_id
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