Status:
COMPLETED
The Efficacy and Safety of AChE Inhibitor Donepezil As Adjunctive Treatment to Mood Stabilizers in Acute Mania
Lead Sponsor:
Shanghai Mental Health Center
Collaborating Sponsors:
The Davis Foundations
Conditions:
Bipolar Disorder
Mania
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
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 stabi...
Detailed Description
Bipolar disorder is a chronic mental illness that affects 1-2% of the general population. Lithium and valproate are effective for treatment of acute mania for many patients. However up to half of pati...
Eligibility Criteria
Inclusion
- Patients have DSM-IV diagnosis of bipolar disorder with acute manic episode who are admitted as inpatient
- Young Mania Rating Scale (YMRS) total score \>20 (based on mean scores of two ratings after admission)
- Physical examination, laboratory results (eg.EKG) from screening visit normal, or abnormal clinically insignificant
Exclusion
- Having history of allergy to donepezil or Lithium.
- Having active suicide or homicide attempt or intent
- Having severe medical conditions or taking multiple medications for medical conditions
- Investigational drug treatment within past 30 days
- Having a drug screen positive for any drug of abuse at screening
- Self-report of active substance abuse in the past 2 weeks or substance dependence in the past 2 months
- Diagnosis of schizophrenia, dementia, delirium, seizure disorder, obsessive compulsive disorder, or unstable medical condition
- Administration of any investigational drug within 30 days of screening
- Pregnancy or lactation
- Asthma requiring chronic medication treatment or ongoing use of anticholinergic medications or cholinomimetics
- Other factors that investigator consider not suitable for the study
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01191918
Start Date
May 1 2005
End Date
April 1 2008
Last Update
August 31 2010
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