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Adjunctive Bright Light Therapy for Patients With Depression

Primary Purpose

Depressive Disorder, Light Therapy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
adjunctive bright white light therapy in the morning
adjunctive bright white light therapy in the afternoon
adjunctive dim red light therapy in the afternoon
Sponsored by
Guangzhou Psychiatric Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring Depression, Bright Light Therapy, Time Period

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 12-75 years old
  • Diagnosed using DSM-5 criteria based on the Structured Clinical Interview for Patient Edition (SCID-P) for adults or Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (Kiddie-SADS-PL) for adolescents for the diagnosis of bipolar I or II disorder or major depressive disorder
  • 24-items Hamilton Depression Rating Scale score ≥ 20, Young Mania Rating Scale score < 6
  • Participants with bipolar disorder taking at least one mood stabilizer, and the types of drugs have not changed in one week;
  • Antidepressants can be taken, and the types of antidepressants have not changed in one week
  • Low-dose benzodiazepines can be used, with a maximum of 2 mg of lorazepam equivalent per day
  • Right-handed
  • Primary school education or above
  • Sign informed consents after a full explanation of this study.

Exclusion Criteria:

  • A history of brain organic disease or severe traumatic brain injury and severe physical disease;
  • Drug, alcohol or other psychoactive substance abusers
  • Severe suicide risk;
  • Received modified electric convulsion therapy (MECT) in the past three months
  • Comorbid with ophthalmic diseases (cataract, macular degeneration, glaucoma, retinitis pigmentosa, etc.) and diseases affecting the retina (retinopathy, diabetes, herpes, etc.)
  • Taking photosensitive drugs (phenothiazines, antimalarials, propranolol, melatonin, hypericum, stimulants or NSAIDs)

Sites / Locations

  • Guangzhou Brain Hospital (Guangzhou Huiai Hospital)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Adjunctive morning BLT group

Adjunctive afternoon BLT group

Adjunctive placebo therapy group

Arm Description

treat participants with adjunctive BLT in the morning

treat participants with adjunctive BLT in the afternoon

treat participants with adjunctive dim red light in the afternoon

Outcomes

Primary Outcome Measures

response rate
Participants with a decrease in 24-items Hamilton Depression Scale (HDRS) score of 50% or more from baseline. HDRS is used to measure the depressive severity；its measured time range is within the past week. In this study, version of 24-items is used. The patients are depressed when the total score are greater than 19 points, and there are no depression when the total scores are less than points.

Secondary Outcome Measures

manic/hypomanic conversion rate
The Young Mania Rating Scale (YMRS) is used to assess manic/hypomanic symptoms and their severity; its measured time range is within the past week. The higher the score, the more severe the symptom. If the total score is greater than or equal to 20, manic episode is considered; if the total score is less than 6, it means there is no manic/hypomanic symptoms.
side effect
record the possible adverse reactions
sleep quality
Pittsburgh Sleep Quality Index (PSQI) is used to evaluate sleep quality for last month. It's made of 7 items; every item is scored 1-4 point. Total score is obtained by adding up the points of 7 items. Total score range is 0~21 point. The sleep quality is worse when the total score is higher.

Full Information

First Posted
November 12, 2020
Last Updated
March 21, 2021
Sponsor
Guangzhou Psychiatric Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04633707
Brief Title
Adjunctive Bright Light Therapy for Patients With Depression
Official Title
Adjunctive Bright Light Therapy for Patients With Depression at Different Time Period: A Randomized Double-Blind, Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Psychiatric Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study would enroll depressed adolescents and adults with bipolar I or II disorder or major depressive disorder who are receiving stable psychiatric medication (excluding patients with hypomania or mania, mixed symptoms, or rapid cycling). Participants would be randomly assigned to treatment with either 1,0000-lux bright white light therapy in the morning or 1,0000-lux bright white light therapy in the afternoon, or <100-lux dim red placebo light therapy in the afternoon (N=59 for each group). Participants would be treated for 6 weeks. Symptoms would be assessed every two weeks with the 24-items Hamilton Depression Scale, the Young Mania Rating Scale, and the Pittsburgh Sleep Quality Index; salivary melatonin and cortisol concentrations will be also measured.
Detailed Description
The investigators would divide the participants enrolled into three groups: adjunctive morning bright light therapy (BLT) group (light intensity: 10000lux, color: white light, duration of each intervention session: 30min, time period of intervention: 7:00~9:00 a.m.), adjunctive afternoon BLT group (light intensity: 10000lux, color: white light, duration of each intervention session: 30min, time period of intervention: 12:00~14:00 p.m.), adjunctive placebo therapy group (light intensity: <100lux, color: dark red, duration of each intervention session: 30min, time period of intervention: 12:00~14:00 p.m.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Light Therapy
Keywords
Depression, Bright Light Therapy, Time Period

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
159 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adjunctive morning BLT group
Arm Type
Experimental
Arm Description
treat participants with adjunctive BLT in the morning
Arm Title
Adjunctive afternoon BLT group
Arm Type
Experimental
Arm Description
treat participants with adjunctive BLT in the afternoon
Arm Title
Adjunctive placebo therapy group
Arm Type
Placebo Comparator
Arm Description
treat participants with adjunctive dim red light in the afternoon
Intervention Type
Device
Intervention Name(s)
adjunctive bright white light therapy in the morning
Intervention Description
the participants would receive adjunctive bright white light therapy in the morning (light intensity: 10000lux, color: white light, duration of each intervention session: 30min, time period: 7:00~9:00) for 6 weeks.
Intervention Type
Device
Intervention Name(s)
adjunctive bright white light therapy in the afternoon
Intervention Description
the participants would receive adjunctive bright white light therapy in the afternoon (light intensity: 10000lux, color: white light, duration of each intervention session: 30min, time period: 12:00~14:00) for 6 weeks.
Intervention Type
Device
Intervention Name(s)
adjunctive dim red light therapy in the afternoon
Intervention Description
the participants received dim red light therapy (light intensity: <100lux, color: dark red, duration of each intervention session: 30min, time period: 12:00~14:00) for 6 weeks.
Primary Outcome Measure Information:
Title
response rate
Description
Participants with a decrease in 24-items Hamilton Depression Scale (HDRS) score of 50% or more from baseline. HDRS is used to measure the depressive severity；its measured time range is within the past week. In this study, version of 24-items is used. The patients are depressed when the total score are greater than 19 points, and there are no depression when the total scores are less than points.
Time Frame
up to week 6
Secondary Outcome Measure Information:
Title
manic/hypomanic conversion rate
Description
The Young Mania Rating Scale (YMRS) is used to assess manic/hypomanic symptoms and their severity; its measured time range is within the past week. The higher the score, the more severe the symptom. If the total score is greater than or equal to 20, manic episode is considered; if the total score is less than 6, it means there is no manic/hypomanic symptoms.
Time Frame
week 2; week 4; week 6
Title
side effect
Description
record the possible adverse reactions
Time Frame
week 2; week 4;week 6
Title
sleep quality
Description
Pittsburgh Sleep Quality Index (PSQI) is used to evaluate sleep quality for last month. It's made of 7 items; every item is scored 1-4 point. Total score is obtained by adding up the points of 7 items. Total score range is 0~21 point. The sleep quality is worse when the total score is higher.
Time Frame
week 2; week 4;week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 12-75 years old Diagnosed using DSM-5 criteria based on the Structured Clinical Interview for Patient Edition (SCID-P) for adults or Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (Kiddie-SADS-PL) for adolescents for the diagnosis of bipolar I or II disorder or major depressive disorder 24-items Hamilton Depression Rating Scale score ≥ 20, Young Mania Rating Scale score < 6 Participants with bipolar disorder taking at least one mood stabilizer, and the types of drugs have not changed in one week; Antidepressants can be taken, and the types of antidepressants have not changed in one week Low-dose benzodiazepines can be used, with a maximum of 2 mg of lorazepam equivalent per day Right-handed Primary school education or above Sign informed consents after a full explanation of this study. Exclusion Criteria: A history of brain organic disease or severe traumatic brain injury and severe physical disease; Drug, alcohol or other psychoactive substance abusers Severe suicide risk; Received modified electric convulsion therapy (MECT) in the past three months Comorbid with ophthalmic diseases (cataract, macular degeneration, glaucoma, retinitis pigmentosa, etc.) and diseases affecting the retina (retinopathy, diabetes, herpes, etc.) Taking photosensitive drugs (phenothiazines, antimalarials, propranolol, melatonin, hypericum, stimulants or NSAIDs)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Kangguang, MD;PHD
Phone
13560360144
Ext
18028619981
Email
linkangguang@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liu Tao, MD
Phone
15017554527
Email
liutaolp@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Kangguang, MD;PHD
Organizational Affiliation
Guangzhou Psychiatric Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou Brain Hospital (Guangzhou Huiai Hospital)
City
Guanzhou
State/Province
Guangdong
ZIP/Postal Code
510370
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Adjunctive Bright Light Therapy for Patients With Depression

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