Bipolar Disorder Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled Evaluation of The Efficacy and Safety of AChE Inhibitor Donepezil As Adjunctive Treatment to Mood Stabilizers in Acute Mania
Verified date | August 2010 |
Source | Shanghai Mental Health Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ministry of Health |
Study type | Interventional |
There is a high rate of partial response to standard thymoleptic medication. In this study the investigators want to evaluate the safety and efficacy of donepezil as adjunctive treatment to mood stabilizers in bipolar disorder with acute mania. The investigators hypotheses were that there would be greater mean reduction in manic symptoms with donepezil augmentation of lithium compared with placebo.
Status | Completed |
Enrollment | 40 |
Est. completion date | April 2008 |
Est. primary completion date | April 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. Patients have DSM-IV diagnosis of bipolar disorder with acute manic episode who are admitted as inpatient 2. Young Mania Rating Scale (YMRS) total score >20 (based on mean scores of two ratings after admission) 3. Physical examination, laboratory results (eg.EKG) from screening visit normal, or abnormal clinically insignificant Exclusion Criteria: 1. Having history of allergy to donepezil or Lithium. 2. Having active suicide or homicide attempt or intent 3. Having severe medical conditions or taking multiple medications for medical conditions 4. Investigational drug treatment within past 30 days 5. Having a drug screen positive for any drug of abuse at screening 6. Self-report of active substance abuse in the past 2 weeks or substance dependence in the past 2 months 7. Diagnosis of schizophrenia, dementia, delirium, seizure disorder, obsessive compulsive disorder, or unstable medical condition 8. Administration of any investigational drug within 30 days of screening 9. Pregnancy or lactation 10. Asthma requiring chronic medication treatment or ongoing use of anticholinergic medications or cholinomimetics 11. Other factors that investigator consider not suitable for the study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Shanghai Mental Health Center | The Davis Foundations |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total score change of Young Mania Rating Scale | Patients were assessed by outcomes assessores at 0 hour(h), 2h,4h,6h,8h,10h,12h,24h,1 week (w), 2w, 4w | from baseline to week 4 | No |
Secondary | Treatment Emergent Symptom Scale | assessed at day 1, week1, week 2, week4 | from baseline to week4 | Yes |
Secondary | Clinical Global Impression | assessed at 0h, 2h,4h,6h,8h,10h,12h,24h,week1, week2, week4 | frome baseline to week 4 | No |
Secondary | Brief Psychiatric Rating Scale | assessed at 0h, 2h,4h,6h,8h,10h,12h,24h,week1, week2, week4 | frome baseline to week 4 | No |
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