Adjunctive Bright Light Therapy in Patients With Bipolar Depression and Eveningness

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05357313

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Depression	Device: Bright light therapy Device: Inactive negative ion generator	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized placebo-controlled trialRandomized placebo-controlled trial

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change of depressive symptoms score [at the end of treatment]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.