Adjunctive Bright Light Therapy in Patients With Bipolar Depression and Eveningness

Last updated: April 11, 2025
Sponsor: Chinese University of Hong Kong
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Bipolar Disorder

Mood Disorders

Treatment

Bright light therapy

Inactive negative ion generator

Clinical Study ID

NCT05357313
2020.676T
14111502
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 andII disorders) by the Structured Clinical Interview for Diagnostic and StatisticalManual of Mental Disorders, 5th edition (DSM-V), Disorders (SCID-V).

  4. a score 20 or above representing current moderate or severe episode of majordepression and a score of at least 1 on items H1 or H2 on the Structured InterviewGuide 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 representseveningness.

  6. On a stable dose of antimanic treatment for bipolar disorder for at least fourweeks.

Exclusion

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 ManiaRating Scale more than 12 at screening

  3. A current or past history of schizophrenia, mental retardation, organic mentaldisorder; or current substance use disorder.

  4. Presence of psychotic symptoms or substantial suicidal risk as judged by theclinician and/or screening instruments.

  5. Presence of contraindications to bright light therapy: for example, history of lightinduced 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 toincapability 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 ordevice.

  9. Receiving regular psychotherapy.

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: Bright light therapy
Phase:
Study Start date:
June 02, 2022
Estimated Completion Date:
February 28, 2026

Study 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 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.

Connect with a study center

  • The Chinese University of Hong Kong

    Hong Kong,
    Hong Kong

    Active - Recruiting

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