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Completed

NCT Number: NCT02009371

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

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.

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Key information

Conditions

Depressive Episodes of Bipolar Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mental Health Institute of Peking University

Beijing, Beijing Municipality, 100191, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bright Light Therapy

Device

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.

dim Red Light therapy

Device

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 outcomes

  1. Reducing rate of HAMD

    Time frame: Change from baselin to 2 weeks after

    We used HAMD to evaluate the major state of depression.

Secondary outcomes

  1. Reducing rate of CGI

    Time frame: Change from baseline to 2 week after

    We use CGI to evaluate the state of depression.

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 12, 2013
Registry last updated
Oct 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.