Adjunctive Bright Light Therapy for Patients With Depression

NCT04633707 | Unknown

• 1 other identifier: Guangzhou Brain Hospital BLT
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder; Light Therapy

Keywords

Depression; Bright Light Therapy; Time Period

Outcome Measures

Primary Outcomes (1)

• 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.

  up to week 6

Secondary Outcomes (3)

• manic/hypomanic conversion rate

  week 2; week 4; week 6

• side effect

  week 2; week 4;week 6

• sleep quality

  week 2; week 4;week 6

Study Arms (3)

Adjunctive morning BLT group

EXPERIMENTAL

treat participants with adjunctive BLT in the morning

Device: adjunctive bright white light therapy in the morning

Adjunctive afternoon BLT group

EXPERIMENTAL

treat participants with adjunctive BLT in the afternoon

Device: adjunctive bright white light therapy in the afternoon

Adjunctive placebo therapy group

PLACEBO COMPARATOR

treat participants with adjunctive dim red light in the afternoon

Device: adjunctive dim red light therapy in the afternoon

Interventions

adjunctive bright white light therapy in the morning DEVICE

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.

Adjunctive morning BLT group

adjunctive bright white light therapy in the afternoon DEVICE

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.

Adjunctive afternoon BLT group

adjunctive dim red light therapy in the afternoon DEVICE

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.

Adjunctive placebo therapy group

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Guangzhou Psychiatric Hospital: lead

Study Sites (1)

Guangzhou Brain Hospital (Guangzhou Huiai Hospital)

Guanzhou, Guangdong, 510370, China

Location

MeSH Terms

Conditions

Depressive Disorder; Depression

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Lin Kangguang, MD;PHD

  Guangzhou Psychiatric Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Kangguang, MD;PHD

CONTACT

13560360144; linkangguang@163.com

Liu Tao, MD

CONTACT

15017554527; liutaolp@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 18, 2020
• Study Start: March 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: July 1, 2022
• Last Updated: March 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)