Depressive Episodes of Bipolar Disorder Clinical Trial
| Verified date | June 2015 |
| Source | Peking University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Ministry of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | July 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Mental Health Institute of Peking University | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Peking University |
China,
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)
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Reducing rate of HAMD | We used HAMD to evaluate the major state of depression. | Change from baselin to 2 weeks after | No |
| Secondary | Reducing rate of CGI | We use CGI to evaluate the state of depression. | Change from baseline to 2 week after | No |