Clinical trial NCT02009371: A Clinical Study of Light Therapy on Depressive Episodes of Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Episodes of Bipolar Disorder
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2013-12-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reducing rate of HAMD
timeFrame: Change from baselin to 2 weeks after
Secondary outcomes:
measure: Reducing rate of CGI
timeFrame: Change from baseline to 2 week after
Other outcomes:
Locations:
city: Beijing
country: China
facility: Mental Health Institute of Peking University
state: Beijing
Study officials:
affiliation: Peking University
name: Xin Yu, professor
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Zhou TH, Dang WM, Ma YT, Hu CQ, Wang N, Zhang GY, Wang G, Shi C, Zhang H, Guo B, Zhou SZ, Feng L, Geng SX, Tong YZ, Tang GW, He ZK, Zhen L, Yu X. Clinical efficacy, onset time and safety of bright light therapy in acute bipolar depression as an adjunctive therapy: A randomized controlled trial. J Affect Disord. 2018 Feb;227:90-96. doi: 10.1016/j.jad.2017.09.038. Epub 2017 Sep 25.