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

Study Overview
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Brief Summary
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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.

Conditions
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Depressive Episodes of Bipolar Disorder

Intervention / Treatment
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* Device: Bright Light therapy
* Device: dim Red Light therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Light therapy<br>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. | Device: Bright Light therapy<br>* In this group, participants will be exposed to the LED treatment device (lightbox) which delivers bright light and meanwhile medicated with just one particular antipsychotics drug(a mood stabilizer or an atypical antipsychotic drug)except of antidepressants.<br>|
| Placebo Comparator: Control group<br>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. | Device: dim Red Light therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reducing rate of HAMD | We used HAMD to evaluate the major state of depression. | Change from baselin to 2 weeks after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reducing rate of CGI | We use CGI to evaluate the state of depression. | Change from baseline to 2 week after |