SchizophreniaNCT00789906
Development of Population Norms of the Computerized Neuropsychological Assessment for Effectiveness of the Antipsychotic Treatment in Schizophrenia
An observational study of Schizophrenia, run by BeerYaakov Mental Health Center at 1 site in Israel.
Trial summary
Schizophrenia affects cognition, emotion, and behavior. Neuropsychological assessment enables a better understanding of antipsychotic effectiveness and the brain processes, underlying cognitive functioning in schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- How many people
- 700 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2008to not given
- Phase
- Observational
- 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 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 700 healthy adults (350 women and 350 men, aged from 18 to 89)
Who may be able to join
- An IQ, which is within normal range.
Who cannot join
- Psychiatric co-morbidity.
- Physical disability or illness.
- A history of severe head injury.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Beer-Yaacov MHC
Beer Yaacov, 70350
Kertzman, 972-8-9776136, research@beerness.health.gov.il
Semion Kertzman, M.D.
About this study
Schizophrenia affects cognition, emotion, and behavior. Neuropsychological assessment enables a better understanding of antipsychotic effectiveness and the brain processes, underlying cognitive functioning in schizophrenia.
Neurocognitive deficits in schizophrenia patients appears to explain up to 61% of the variance of functional outcome and is an important predictor of social reintegration (Peuskens et al, 2005) and independent living activitiy (Green et al, 2004). Impaired social functioning within schizophrenia population has been associated with increased health-care costs. Since social and occupational disability may generate the largest indirect costs of the illness, treatment of cognitive deficits has an enormous impact on the cost and disability associated with schizophrenia (McGurk and Mueser, 2004).
Read more
However, the gap between cognitive science and clinical practice limits the implementation of cognitive assessment in the routine evaluation of schizophrenia patients. Pharmaceutical industry initiated numerous large scale, multisite studies on the impact of novel antipsychotics on cognitive deficits in schizophrenia patients.
The aim of this research is to develop population norms of the computerized neuropsychological assessment for effectiveness of the antipsychotic treatment in schizophrenia.
- Conditions
- Schizophrenia
- Keywords
- Computerized Neuropsychological Assessment, Development of Population Norms of the Computerized Neuropsychological Assessment
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | 350 healthy women , aged from 18 to 89 | |
| 2 | 350 healthy men, aged from 18 to 89 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startJul 2008
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
- Observational
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeerYaakov Mental Health Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789906
- Sponsor's protocol ID
- 223CTIL
- Status last verified
- Nov 2008
- First submitted
- 11 Nov 2008
- Last updated
- 13 Nov 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Population Norms of the Computerized Neuropsychological Assessment for Effectiveness of the Antipsychotic Treatment in Schizophrenia
- ClinicalTrials.gov ID
- NCT00789906
- Acronym / sponsor ID
- 223CTIL
- Conditions
- Schizophrenia
- Keywords
- Computerized Neuropsychological Assessment, Development of Population Norms of the Computerized Neuropsychological Assessment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- BeerYaakov Mental Health CenterOther government
- Study start
- Jul 2008
- First posted
- 13 Nov 2008 (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.
Schizophrenia affects cognition, emotion, and behavior. Neuropsychological assessment enables a better understanding of antipsychotic effectiveness and the brain processes, underlying cognitive functioning in schizophrenia.
Neurocognitive deficits in schizophrenia patients appears to explain up to 61% of the variance of functional outcome and is an important predictor of social reintegration (Peuskens et al, 2005) and independent living activitiy (Green et al, 2004). Impaired social functioning within schizophrenia population has been associated with increased health-care costs. Since social and occupational disability may generate the largest indirect costs of the illness, treatment of cognitive deficits has an enormous impact on the cost and disability associated with schizophrenia (McGurk and Mueser, 2004).
However, the gap between cognitive science and clinical practice limits the implementation of cognitive assessment in the routine evaluation of schizophrenia patients. Pharmaceutical industry initiated numerous large scale, multisite studies on the impact of novel antipsychotics on cognitive deficits in schizophrenia patients.
The aim of this research is to develop population norms of the computerized neuropsychological assessment for effectiveness of the antipsychotic treatment in schizophrenia.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –350 healthy women , aged from 18 to 89 |
| 2 | – | –350 healthy men, aged from 18 to 89 |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 700 healthy adults (350 women and 350 men, aged from 18 to 89)
Key inclusion criteria (1 listed)
- An IQ, which is within normal range.
Key exclusion criteria (3 listed)
- Psychiatric co-morbidity.
- Physical disability or illness.
- A history of severe head injury.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2008.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, 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 3 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 13 Nov 2008. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Semyon Kertzman, MD (972-8-9776136, research@beerness.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 13 Nov 2008.