Bipolar DisorderPhase 4NCT01191918
The Efficacy and Safety of AChE Inhibitor Donepezil As Adjunctive Treatment to Mood Stabilizers in Acute Mania
A Phase 4 study testing Donepezil and Lithium in people with Bipolar Disorder and Mania, run by Shanghai Mental Health Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bipolar Disorder, Mania
- What is being tested?
- Donepezil and Lithium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Apr 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
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
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.
Read the 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.
- Conditions
- Bipolar Disorder, Mania
- Being tested
- Donepezil and Lithium, Placebo plus Lithium
- Keywords
- acetylcholinesterase inhibitor, donepezil, bipolar disorder, mania, lithium
- Medical subject headings
- Bipolar Disorder, Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donepezil and LithiumDrug
Also called Aricept
Donepezil dose will be started at 5mg/d and increased to 10 mg/d in 1 week.
Placebo plus LithiumDrug
| Study group | Role | What they receive |
|---|---|---|
| donepezil | Experimental | donepezil plus Lithium Receives: Drug: Donepezil and Lithium |
| Control | Placebo comparator | Placebo plus Lithium Receives: Drug: Placebo plus Lithium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from baseline to week 4
Secondary outcomes (3)
Treatment Emergent Symptom Scale
assessed at day 1, week1, week 2, week4
Measured: from baseline to week4
Clinical Global Impression
assessed at 0h, 2h,4h,6h,8h,10h,12h,24h,week1, week2, week4
Measured: frome baseline to week 4
Brief Psychiatric Rating Scale
assessed at 0h, 2h,4h,6h,8h,10h,12h,24h,week1, week2, week4
Measured: frome baseline to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2010 (estimated)
- Study startMay 2005
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Davis Foundations
- Investigators
- Zhen Lu, MD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191918
- Sponsor's protocol ID
- Zlu001
- Status last verified
- Aug 2010
- First submitted
- 29 Aug 2010
- Last updated
- 31 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01191918
- Acronym / sponsor ID
- Zlu001
- Conditions
- Bipolar Disorder, Mania
- Keywords
- acetylcholinesterase inhibitor, donepezil, bipolar disorder, mania, lithium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- The Davis Foundations
- Study start
- May 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 31 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| donepezil | Experimental | Drug: Donepezil and Lithiumdonepezil plus Lithium |
| Control | Placebo comparator | Drug: Placebo plus LithiumPlacebo plus Lithium |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donepezil and LithiumAlso: AriceptDonepezil dose will be started at 5mg/d and increased to 10 mg/d in 1 week. | Drug | donepezil |
| Placebo plus Lithium | Drug | Control |
Primary outcome
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
3 secondary outcomes
Treatment Emergent Symptom Scale
Time frame: from baseline to week4
Clinical Global Impression
Time frame: frome baseline to week 4
Brief Psychiatric Rating Scale
Time frame: frome baseline to week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhen Lu, MD principal investigator
Shanghai Mental Health Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Donepezil and Lithium in people with Bipolar Disorder and Mania, run by Shanghai Mental Health Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total score change of Young Mania Rating Scale (time frame: from baseline to week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2010.