Adjunctive Bright Light Therapy in Patients With Bipolar Depression and Eveningness

NCT ID: NCT05357313

Last Updated: 2025-04-16

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-02

Study Completion Date

2026-02-28

Brief Summary

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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

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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 explore the effects of BLT on sleep-wake changes and the sleep disturbances.

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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Bipolar Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized placebo-controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The subjects will be explained that the study aims to test the efficacy of the different modalities of non-pharmacological treatments for depression including bright light therapy and the negative ion generator, without mentioning which one is the placebo. An independent outcome assessor will be blinded to the treatment allocation throughout the study.

Study Groups

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Bright light therapy group

10,000lux bright light

Group Type EXPERIMENTAL

Bright light therapy

Intervention Type DEVICE

Exposure to 10,000lux bright light for 30minutes a day for six weeks

Placebo group

inactive negative ion generator

Group Type PLACEBO_COMPARATOR

Inactive negative ion generator

Intervention Type DEVICE

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

Intervention Type DEVICE

Inactive negative ion generator

Exposure to an inactive negative ion generator for 30 minutes a day for six weeks

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Aged 18-65 years.
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

1. Major Depressive Disorder fulfilling the Seasonal Pattern Specifier of the DSM-V (Seasonal Affective Disorder).
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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Joey WY Chan

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Joey WY Chan

Role: CONTACT

+852 39197647

Facility Contacts

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Joey WY Chan, FHKAM(Psych)

Role: primary

+862 39197647

Jessie Tsang

Role: backup

+852 39197792

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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