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

NCT01191918 | Completed Phase 4 DMC

• 1 other identifier: Zlu001
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bipolar Disorder; Mania

Keywords

acetylcholinesterase inhibitor; donepezil; bipolar disorder; mania; lithium

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Treatment Emergent Symptom Scale

  from baseline to week4

• Clinical Global Impression

  frome baseline to week 4

• Brief Psychiatric Rating Scale

  frome baseline to week 4

Study Arms (2)

donepezil

EXPERIMENTAL

donepezil plus Lithium

Drug: Donepezil and Lithium

Control

PLACEBO COMPARATOR

Placebo plus Lithium

Drug: Placebo plus Lithium

Interventions

Donepezil and Lithium DRUG

Donepezil dose will be started at 5mg/d and increased to 10 mg/d in 1 week.

Also known as: Aricept

donepezil

Placebo plus Lithium DRUG

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• The Davis Foundations: collaborator

MeSH Terms

Conditions

Bipolar Disorder; Mania

Interventions

Donepezil; Lithium

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• Zhen Lu, MD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 29, 2010
• First Posted: August 31, 2010
• Study Start: May 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: August 31, 2010

Record last verified: 2010-08