Depressive Episodes of Bipolar Disorder
Conditions
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.
Interventions
DEVICEBright Light therapy
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.
DEVICEdim 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.
Sponsors
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reducing rate of HAMD | Change from baselin to 2 weeks after | We used HAMD to evaluate the major state of depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reducing rate of CGI | Change from baseline to 2 week after | We use CGI to evaluate the state of depression. |
Countries
China
Outcome results
None listed