Adjunctive Bright Light Therapy in Patients With Bipolar Depression and Eveningness

NCT05357313 | Active Not Recruiting

• 2 other identifiers: 2020.676T14111502
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Depression

Keywords

Bipolar depression; Eveningness; Bright light therapy

Outcome Measures

Primary Outcomes (1)

• Change of depressive symptoms score

  Change in the score of the Structural Interview Guide for the Hamilton Depression Rating Scale with atypical depression supplement (SIGH-ADS), SIGH-ADS scores range from 0-79; higher score indicates greater depression severity.

  at the end of treatment

Secondary Outcomes (1)

• Change of insomnia symptoms

  at the end of treatment

Study Arms (2)

Bright light therapy group

EXPERIMENTAL

10,000lux bright light

Device: Bright light therapy

Placebo group

PLACEBO COMPARATOR

inactive negative ion generator

Device: Inactive negative ion generator

Interventions

Bright light therapy DEVICE

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

Bright light therapy group

Inactive negative ion generator DEVICE

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

Placebo group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Randomized placebo-controlled trial

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 2, 2022
• Study Start: June 2, 2022
• Primary Completion: November 28, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)