A Clinical Study of Light Therapy on Depressive Episodes of Bipolar Disorder

Peking University

Status: Completed

Conditions: Depressive Episodes of Bipolar Disorder

Treatments: Device: dim Red Light therapy; Device: Bright Light therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02009371

SF2011-4023-03

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy and safety of light-emitting diode(LED) light therapy on Chinese patients with Depressive Episodes of Bipolar Disorder and to gather prime research data and application parameters of LED light source which is not currently available in China.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ages 18 to 65 years
• comply with the DSM-IV diagnosis of Bipolar I or II Disorder and a current depressive episode
• HAMD score ≥17 points
• intake of just one particular psychotropic drug(a mood stabilizer or an atypical antipsychotic drug) except of antidepressants and lasted 2 weeks.

Exclusion criteria

• inability to provide informed consent;
• previous treatment with BLT
• presence of another major psychiatric illness such as schizophrenia, schizoaffective disorder, lifetime alcohol or substance dependence
• diagnosed with a rapid-cycling bipolar disorder or currently in the mixed state or YMRS score>12 points
• use of antidepressants medications
• significant medical illness such as diabetes mellitus,heart failure, renal failure, severe liver function abnormalities,hyperthyroidism or hypothyroidism
• pregnancy;
• received magnified electroconvulsive therapy orRepetitive Transcranial Magnetic Stimulation in the past 3 months
• an eye condition that could be negatively affected by bright light
• suicidal risk or other factor making trial participation clinically inappropriate.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Light therapy

Experimental group

Description:

In this group, participants will be exposed to the LED treatment device (light box) which delivers bright light and meanwhile medicated with just one particular antipsychotics drug(a mood stabilizer or an atypical antipsychotic drug)except of antidepressants.

Treatment:

Device: Bright Light therapy

Control group

Placebo Comparator group

Description:

In this group, participants will be exposed to the same LED treatment device (light box) which delivers dim red light,which is considered to be biologically inactive, and meanwhile medicated with just one particular antipsychotics drug(a mood stabilizer or an atypical antipsychotic drug)except of antidepressants.

Treatment:

Device: dim Red Light therapy