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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01191918
First Posted: August 31, 2010
Last Update Posted: August 31, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Davis Foundations
Information provided by:
Shanghai Mental Health Center
  Purpose
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.

Condition Intervention Phase
Bipolar Disorder Mania Drug: Donepezil and Lithium Drug: Placebo plus Lithium Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Shanghai Mental Health Center:

Primary Outcome Measures:
  • Total score change of Young Mania Rating Scale [ Time Frame: from baseline to week 4 ]
    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 [ Time Frame: from baseline to week4 ]
    assessed at day 1, week1, week 2, week4

  • Clinical Global Impression [ Time Frame: frome baseline to week 4 ]
    assessed at 0h, 2h,4h,6h,8h,10h,12h,24h,week1, week2, week4

  • Brief Psychiatric Rating Scale [ Time Frame: frome baseline to week 4 ]
    assessed at 0h, 2h,4h,6h,8h,10h,12h,24h,week1, week2, week4


Enrollment: 40
Study Start Date: May 2005
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: donepezil
donepezil plus Lithium
Drug: Donepezil and Lithium
Donepezil dose will be started at 5mg/d and increased to 10 mg/d in 1 week.
Other Name: Aricept
Placebo Comparator: Control
Placebo plus Lithium
Drug: Placebo plus Lithium

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191918


Sponsors and Collaborators
Shanghai Mental Health Center
The Davis Foundations
Investigators
Principal Investigator: Zhen Lu, MD Shanghai Mental Health Center
  More Information

Responsible Party: Zheng Lu, Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine
ClinicalTrials.gov Identifier: NCT01191918     History of Changes
Other Study ID Numbers: Zlu001
First Submitted: August 29, 2010
First Posted: August 31, 2010
Last Update Posted: August 31, 2010
Last Verified: August 2010

Keywords provided by Shanghai Mental Health Center:
acetylcholinesterase inhibitor
donepezil
bipolar disorder
mania
lithium

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Donepezil
Lithium Carbonate
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Antidepressive Agents
Psychotropic Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants