SchizophreniaPhase 4NCT00465283
Donepezil Double Blind Trial for ECT Memory Disfunction
A Phase 4 study testing Donepezil in people with Schizophrenia and Schizoaffective Disorder, run by BeerYaakov Mental Health Center at 1 site in Israel.
Trial summary
This is a double blind randomized investigation of donepezil for patients suffering from schizophrenia, undergoing ECT. Patients will be randomized to receive either donezepil or plasebo, in order to gauge whether donezepil has a protective effect on memory disfunction, while patients are treated with ECT. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
- What is being tested?
- Donepezil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- May 2007to Jan 2010
- 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
- Schizophrenia, Schizoaffective disorder, schizophreniform disorder patients who meet criteria for diagnoses by DSM-IV criteria and evaluated by the Structured Clinical Interview for DSM-IV (SCID)
Who cannot join
- History of serious neurological disorders including neurodegenerative deseases, mental retardation, substance and/or alcohol dependence.
- Pregnant women
- Patients who recieved ECT within 6 month
- Patients whith contraindication to Donepezil treatment.
- Patients with Lithium treatment
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Beer Yaakov MHC
Beer Yaacov, 70350
Tali Nachshoni, M.D., 972-8-9258372, bynachshoni@beer-ness.health.gov.il
Tali Nachshoni, MD
About this study
This is a double blind randomized investigation of donepezil for patients suffering from schizophrenia, undergoing ECT.
Patients will be randomized to receive either donezepil or plasebo, in order to gauge whether donezepil has a protective effect on memory disfunction, while patients are treated with ECT. Several parameters will be invistigated at baseline: general psychopathological measures, memory function scales, side effects scales. The same measurements will be taken throughout the trial and one month after ending the ECT.
- Being tested
- Donepezil
- Keywords
- Donepezil, ECT, Memory Disfunction
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Epilepsy, Rolandic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
Also called Donepezil - Memorit
Tab.Donepezil 5 mg once daily during ECT treatment and the month after the last ECT treatment
| Study group | Role | What they receive |
|---|---|---|
| Donepezil | Active comparator | Not described Receives: Drug: Donepezil |
| placebo | Placebo comparator | Not described Receives: Drug: Donepezil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data will be analyzed using SPSS for Windows.
Measured: after 5 ECT treatments
Results of the memory and neurocognitive measures will be examined
Measured: after 8 ECT treatments
using repeated MANOVA with before, within and after ECT treatment.
Measured: 1 month after the last ECT treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2007 (estimated)
- Study startMay 2007
- Primary completionJan 2010 (estimated)
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeerYaakov Mental Health Center
- Sponsor type
- Other government
- Investigators
- Tali Nachshoni, MD, Principal investigator, Beer Yaakov Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465283
- Sponsor's protocol ID
- Donepezil-180CTIL
- Status last verified
- Jan 2009
- First submitted
- 22 Apr 2007
- Last updated
- 27 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donepezil Double Blind Trial for ECT Memory Disfunction
- ClinicalTrials.gov ID
- NCT00465283
- Acronym / sponsor ID
- Donepezil-180CTIL
- Keywords
- Donepezil, ECT, Memory Disfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- BeerYaakov Mental Health CenterOther government
- Study start
- May 2007
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 24 Apr 2007 (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.
This is a double blind randomized investigation of donepezil for patients suffering from schizophrenia, undergoing ECT.
Patients will be randomized to receive either donezepil or plasebo, in order to gauge whether donezepil has a protective effect on memory disfunction, while patients are treated with ECT. Several parameters will be invistigated at baseline: general psychopathological measures, memory function scales, side effects scales. The same measurements will be taken throughout the trial and one month after ending the ECT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donepezil | Active comparator | Drug: Donepezil |
| placebo | Placebo comparator | Drug: Donepezil |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Schizophrenia, Schizoaffective disorder, schizophreniform disorder patients who meet criteria for diagnoses by DSM-IV criteria and evaluated by the Structured Clinical Interview for DSM-IV (SCID)
Key exclusion criteria (5 listed)
- History of serious neurological disorders including neurodegenerative deseases, mental retardation, substance and/or alcohol dependence.
- Pregnant women
- Patients who recieved ECT within 6 month
- Patients whith contraindication to Donepezil treatment.
- Patients with Lithium treatment
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 |
|---|---|---|
| DonepezilAlso: Donepezil - MemoritTab.Donepezil 5 mg once daily during ECT treatment and the month after the last ECT treatment | Drug | Donepezil, placebo |
Primary outcome
Data will be analyzed using SPSS for Windows.
Time frame: after 5 ECT treatments
Results of the memory and neurocognitive measures will be examined
Time frame: after 8 ECT treatments
using repeated MANOVA with before, within and after ECT treatment.
Time frame: 1 month after the last ECT treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2009.
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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.
Tali Nachshoni, MD principal investigator
Beer Yaakov Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Donepezil in people with Schizophrenia and Schizoaffective Disorder, run by BeerYaakov Mental Health Center at 1 site in Israel.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 27 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tali Nachshoni, MD (972-8-9258372, bynachshoni@beer-ness.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data will be analyzed using SPSS for Windows. (time frame: after 5 ECT treatments). The study lists 3 primary outcomes in all. 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 27 Jan 2009.