Back to results

Adjunctive Bright Light Therapy in Patients With Bipolar Depression and Eveningness

Primary Purpose

Bipolar Depression

Status

Recruiting

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

Bright light therapy

Inactive negative ion generator

About this trial

This is an interventional treatment trial for Bipolar Depression focused on measuring Bipolar depression, Eveningness, Bright light therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bright light therapy group

Placebo group

Arm Description

10,000lux bright light

inactive negative ion generator

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05357313

First Posted

April 27, 2022

Last Updated

January 9, 2023

Sponsor

Chinese University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT05357313

Brief Title

Adjunctive Bright Light Therapy in Patients With Bipolar Depression and Eveningness

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 2, 2022 (Actual)

Primary Completion Date

August 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Depression

Keywords

Bipolar depression, Eveningness, Bright light therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized placebo-controlled trial

Masking

ParticipantOutcomes 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.

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bright light therapy group

Arm Type

Experimental

Arm Description

10,000lux bright light

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

inactive negative ion generator

Intervention Type

Device

Intervention Name(s)

Bright light therapy

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Inactive negative ion generator

Intervention Description

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

Primary Outcome Measure Information:

Title

Change of depressive symptoms score

Description

Time Frame

at the end of treatment

Secondary Outcome Measure Information:

Title

Change of insomnia symptoms

Description

The change in the score of the Insomnia Severity Index (ISI), which ranges from 0-28, higher score indicates higher severity of insomnia

Time Frame

at the end of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Joey WY Chan

Phone

+852 39197647

joeywychan@cuhk.edu.hk

Facility Information:

Facility Name

The Chinese University of Hong Kong

City

Hong Kong

Country

Hong Kong

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joey WY Chan, FHKAM(Psych)

Phone

+862 39197647

joeywychan@cuhk.edu.hk

First Name & Middle Initial & Last Name & Degree

Jessie Tsang

Phone

+852 39197792

jessietsang@cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Adjunctive Bright Light Therapy in Patients With Bipolar Depression and Eveningness

We'll reach out to this number within 24 hrs