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.

Study Overview

• Status: Completed
• Conditions: Depressive Episodes of Bipolar Disorder
• Intervention / Treatment: Device: Bright Light therapy; Device: dim Red Light therapy

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Mental Health Institute of Peking University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Bright 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.
Placebo Comparator: Control group; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University
• Investigators: Principal Investigator: Xin Yu, professor, Peking University

Publications and helpful links

General Publications

• LOOH,HALE A,D'HAENEN H. Detemination of the does of agomelatine,a melatoninergic agonist and selective 5-HT(2C) anlagonist,in the treatment of major depressive disorder:a placebo-controlled does range study[J].Int Clin Psychopharmacol,2002,17(5):239-247. OLIE JP,KASPER S. Efficacy of agomelatine,a MT1/MT2 receptor agonist with 5-HT(2C) antagonisitic properties, in major depressive disorder[J]. Int J Neuropsychopharmacol,2007,10(5):661-673. GUILLEMINAULT C. Efficacy of agomelatine versus venlafaxine on subjective sleep of patients with major depressive disorder [J]. Eur Neuropsychopharmacol,2005,15 Suppl3:S419-S420. LOPES MC.QUEPA-SALVAMA,GUILLEMINAULT C,Non-REM sleep instability in patinents with major depressive disorder;subjective improvement and improvement of non-REM sleep in stability with treatment(agomelatine)[J].Sleep Med,2007,9(1):33-41. Daniela Eser,Thomas C Baghai,etc.Agomelatine: The evidence for its place in the treatment of depression[J].Core Evidence 2009:3 171-179 Michele Fornaro, Davide Prestia,etc.A Systematic, Updated Review on the Antidepressant Agomelatine Focusing on its Melatonergic Modulation[J].Current Neuropharmacology, 2010, Vol. 8, No. 3:287-304 Chang-Ho Sohn,Raymond W. Lam.Update on the Biology of Seasonal Affective Disorder[J].CNS Spectr. 2005;10(8):635-646 Michael Terman,Jiuan Su Terman.Light Therapy for Seasonal and Nonseasonal Depression: Efficacy, Protocol, Safety, and Side Effects[J]CNS Spectr. 2005;10(8):647-663 Robert D. Levitan.Psychopharmacology for the Clinician Psychopharmacologie pratique[J].Rev Psychiatr Neurosci 2005;30(1)
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: May 22, 2013
• First Submitted That Met QC Criteria: December 8, 2013
• First Posted (Estimate): December 12, 2013

Study Record Updates

• Last Update Posted (Estimate): October 20, 2015
• Last Update Submitted That Met QC Criteria: October 19, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Bipolar and Related Disorders; Depression; Depressive Disorder; Bipolar Disorder
• Other Study ID Numbers: SF2011-4023-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No