Overview

The Efficacy and Safety of AChE Inhibitor Donepezil As Adjunctive Treatment to Mood Stabilizers in Acute Mania

Status:
Completed
Trial end date:
2008-04-01
Target enrollment:
0
Participant gender:
All
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 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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shanghai Mental Health Center
Collaborator:
The Davis Foundations
Treatments:
Donepezil
Lithium Carbonate
Criteria
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