Adjunctive Bright Light Therapy for Patients With Depression

NCT ID: NCT04633707

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2022-07-31

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.).

Conditions

Depressive Disorder; Light Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Adjunctive morning BLT group

treat participants with adjunctive BLT in the morning

Group Type: EXPERIMENTAL

adjunctive bright white light therapy in the morning

Intervention Type: 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 afternoon BLT group

treat participants with adjunctive BLT in the afternoon

Group Type: EXPERIMENTAL

adjunctive bright white light therapy in the afternoon

Intervention Type: 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 placebo therapy group

treat participants with adjunctive dim red light in the afternoon

Group Type: PLACEBO_COMPARATOR

adjunctive dim red light therapy in the afternoon

Intervention Type: 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.

Interventions

adjunctive bright white light therapy in the morning

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

adjunctive bright white light therapy in the afternoon

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

adjunctive dim red light therapy in the afternoon

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.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Psychiatric Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Kangguang Lin

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lin Kangguang, MD;PHD

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Psychiatric Hospital

Locations

Guangzhou Brain Hospital (Guangzhou Huiai Hospital)

Guanzhou, Guangdong, China

Countries

China

Central Contacts

Lin Kangguang, MD;PHD

Role: CONTACT

linkangguang@163.com

13560360144 ext. 18028619981

Liu Tao, MD

Role: CONTACT

liutaolp@163.com

15017554527

Other Identifiers

Guangzhou Brain Hospital BLT

Identifier Type: -

Identifier Source: org_study_id