Status:
RECRUITING
Adjunctive Bright Light Therapy in Patients With Bipolar Depression and Eveningness
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Bipolar Depression
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This is a randomized placebo-controlled trial to examine the efficacy of six-week bright light therapy as adjunctive treatment for patient with bipolar depression and eveningness.
Detailed Description
This randomized placebo-controlled trial aims to evaluate the efficacy of adjunctive BLT in addition to their maintenance treatment in reducing depressive symptoms. The second aim of the study is to e...
Eligibility Criteria
Inclusion
- Aged 18-65 years.
- Is capable to give informed consent.
- 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).
- 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.
- A score of 41 or less by the Morningness-Eveningness Questionnaire which represents eveningness.
- On a stable dose of antimanic treatment for bipolar disorder for at least four weeks.
Exclusion
- Major Depressive Disorder fulfilling the Seasonal Pattern Specifier of the DSM-V (Seasonal Affective Disorder).
- A past history of rapid-cycling within the past twelve months or a Young Mania Rating Scale more than 12 at screening
- A current or past history of schizophrenia, mental retardation, organic mental disorder; or current substance use disorder.
- Presence of psychotic symptoms or substantial suicidal risk as judged by the clinician and/or screening instruments.
- 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
- Significant medical condition/ hearing impairment/ speech deficit leading to incapability of completing clinical interview.
- Regular shift-workers or trans-meridian flight in the past 3 months or during study
- Enrolment in another clinical trial of an investigational medicinal product or device.
- Receiving regular psychotherapy.
Key Trial Info
Start Date :
June 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05357313
Start Date
June 2 2022
End Date
February 1 2026
Last Update
April 16 2025
Active Locations (1)
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1
The Chinese University of Hong Kong
Hong Kong, Hong Kong