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

NCT02009371 | Completed

• 1 other identifier: SF2011-4023-03
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Episodes of Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Reducing rate of HAMD

  We used HAMD to evaluate the major state of depression.

  Change from baselin to 2 weeks after

Secondary Outcomes (1)

• Reducing rate of CGI

  Change from baseline to 2 week after

Study Arms (2)

Light therapy

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

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.

Light therapy

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.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Mental Health Institute of Peking University

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (2)

• 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)

  BACKGROUND

• 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.

  PMID: 29053981 DERIVED

MeSH Terms

Interventions

Ultraviolet Therapy

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Officials

• Xin Yu, professor

  Peking University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: December 12, 2013
• Study Start: January 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 20, 2015

Record last verified: 2015-06

Locations

CN (1)