Adjunctive Bright Light Therapy in Patients With Bipolar Depression and Eveningness

A Randomized Placebo-controlled Trial for Adjunctive Bright Light Therapy in Patients With Bipolar Depression and Eveningness

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.

Study Overview

• Status: Recruiting
• Conditions: Bipolar Depression
• Intervention / Treatment: Device: Bright light therapy; Device: Inactive negative ion generator

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joey WY Chan; Phone Number: +852 39197647; Email: joeywychan@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • The Chinese University of Hong Kong
    • Contact: Joey WY Chan, FHKAM(Psych); Phone Number: +862 39197647; Email: joeywychan@cuhk.edu.hk
    • Contact: Jessie Tsang; Phone Number: +852 39197792; Email: jessietsang@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bright light therapy group; 10,000lux bright light	Device: Bright light therapy; Exposure to 10,000lux bright light for 30minutes a day for six weeks
Placebo Comparator: Placebo group; inactive negative ion generator	Device: Inactive negative ion generator; Exposure to an inactive negative ion generator for 30 minutes a day for six weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of insomnia symptoms	The change in the score of the Insomnia Severity Index (ISI), which ranges from 0-28, higher score indicates higher severity of insomnia	at the end of treatment

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Bipolar depression; Bright light therapy; Eveningness
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Bipolar and Related Disorders; Depression; Depressive Disorder; Bipolar Disorder
• Other Study ID Numbers: 2020.676T; 14111502 (Other Grant/Funding Number: General Research Fund (GRF), Research Grants Council, University Grant Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No