Back to resultsThe Efficacy and Safety of AChE Inhibitor Donepezil As Adjunctive Treatment to Mood Stabilizers in Acute Mania
Primary Purpose
Bipolar Disorder, Mania
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Donepezil and Lithium
Placebo plus Lithium
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring acetylcholinesterase inhibitor, donepezil, bipolar disorder, mania, lithium
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
donepezil
Control
Arm Description
donepezil plus Lithium
Placebo plus Lithium
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Treatment Emergent Symptom Scale
assessed at day 1, week1, week 2, week4
Clinical Global Impression
assessed at 0h, 2h,4h,6h,8h,10h,12h,24h,week1, week2, week4
Brief Psychiatric Rating Scale
assessed at 0h, 2h,4h,6h,8h,10h,12h,24h,week1, week2, week4
Full Information
NCT ID
NCT01191918
First Posted
August 29, 2010
Last Updated
August 30, 2010
Sponsor
Shanghai Mental Health Center
Collaborators
The Davis Foundations
1. Study Identification
Unique Protocol Identification Number
NCT01191918
Brief Title
The Efficacy and Safety of AChE Inhibitor Donepezil As Adjunctive Treatment to Mood Stabilizers in Acute Mania
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shanghai Mental Health Center
Collaborators
The Davis Foundations
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
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 patients do not respond adequately to currently approved treatments in the acute phase of mania. More effective treatment for mania are need. Imbalance in cholinergic and adrenergic tone has long been postulated in the pathophysiology of bipolar disorder. In the pathophysiology of mania,relative cholinergic hypoactivity was being implicated. Donepezil is a centrally acting reversible acetylcholinesterase inhibitor. It is approved for the treatment of Alzheimer's disease. In an open case series with standardized ratings, addition of donepezil 5-10 mg/day to ongoing mood-stabilizer treatment was associated with marked improvement in treatment-resistant mania. We want to conduct a 4-week randomized, double-blind, placebo-controlled trial of donepezil as augmentation of lithium in patients with acute manic episode to evaluate the safety and efficacy of donepezil as adjunctive treatment to mood stabilizers in bipolar disorder with acute mania.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Mania
Keywords
acetylcholinesterase inhibitor, donepezil, bipolar disorder, mania, lithium
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
donepezil
Arm Type
Experimental
Arm Description
donepezil plus Lithium
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo plus Lithium
Intervention Type
Drug
Intervention Name(s)
Donepezil and Lithium
Other Intervention Name(s)
Aricept
Intervention Description
Donepezil dose will be started at 5mg/d and increased to 10 mg/d in 1 week.
Intervention Type
Drug
Intervention Name(s)
Placebo plus Lithium
Primary Outcome Measure Information:
Title
Total score change of Young Mania Rating Scale
Description
Patients were assessed by outcomes assessores at 0 hour(h), 2h,4h,6h,8h,10h,12h,24h,1 week (w), 2w, 4w
Time Frame
from baseline to week 4
Secondary Outcome Measure Information:
Title
Treatment Emergent Symptom Scale
Description
assessed at day 1, week1, week 2, week4
Time Frame
from baseline to week4
Title
Clinical Global Impression
Description
assessed at 0h, 2h,4h,6h,8h,10h,12h,24h,week1, week2, week4
Time Frame
frome baseline to week 4
Title
Brief Psychiatric Rating Scale
Description
assessed at 0h, 2h,4h,6h,8h,10h,12h,24h,week1, week2, week4
Time Frame
frome baseline to week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhen Lu, MD
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Efficacy and Safety of AChE Inhibitor Donepezil As Adjunctive Treatment to Mood Stabilizers in Acute Mania
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