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

Not Applicable

Completed

• Conditions: Depressive Episodes of Bipolar Disorder
• Interventions: Device: Bright Light therapy; Device: dim Red Light therapy

• Registration Number: NCT02009371
• Lead Sponsor: Peking University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-05-22
• Study First Submitted QC: 2013-12-08
• Study First Posted: 2013-12-12
• Primary Completion: 2015-03
• Status Verified: 2015-06
• Study Completion: 2015-07
• Last Update Submitted: 2015-10-19
• Last Update Posted: 2015-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Light therapy	Bright Light therapy	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.
Control group	dim Red Light therapy	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.

Primary Outcome Measures

Name	Time	Method
Reducing rate of HAMD	Change from baselin to 2 weeks after	We used HAMD to evaluate the major state of depression.

Secondary Outcome Measures

Name	Time	Method
Reducing rate of CGI	Change from baseline to 2 week after	We use CGI to evaluate the state of depression.

Trial Locations

Locations (1)

Mental Health Institute of Peking University; 🇨🇳 Beijing, Beijing, China