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

Primary Purpose

Depressive Episodes of Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Bright Light therapy
dim Red Light therapy
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Episodes of Bipolar Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mental Health Institute of Peking University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Light therapy

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Reducing rate of HAMD
We used HAMD to evaluate the major state of depression.

Secondary Outcome Measures

Reducing rate of CGI
We use CGI to evaluate the state of depression.

Full Information

First Posted
May 22, 2013
Last Updated
October 19, 2015
Sponsor
Peking University
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1. Study Identification

Unique Protocol Identification Number
NCT02009371
Brief Title
A Clinical Study of Light Therapy on Depressive Episodes of Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Episodes of Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Light therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Bright Light therapy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
dim Red Light therapy
Intervention Description
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 Outcome Measure Information:
Title
Reducing rate of HAMD
Description
We used HAMD to evaluate the major state of depression.
Time Frame
Change from baselin to 2 weeks after
Secondary Outcome Measure Information:
Title
Reducing rate of CGI
Description
We use CGI to evaluate the state of depression.
Time Frame
Change from baseline to 2 week after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Yu, professor
Organizational Affiliation
Peking University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mental Health Institute of Peking University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
background
PubMed Identifier
29053981
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.
Results Reference
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A Clinical Study of Light Therapy on Depressive Episodes of Bipolar Disorder

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