1. How is the development of cognition over the time period of one year, assessed by the MATRICS cognitive test battery, in a study population of First Episode Schizophrenia patients and Ultra High Risk subjects?2. What is the potential predictive…
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Source
Brief title
Condition
- Disturbances in thinking and perception
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The most important study parameters are the results of the cognitive test
battery MATRICS with an interval of 1 year. Using the MATRICS the course of
cognitive functioning can be assessed and in the High Risk group, the persons
that make the transition to psychosis can be tested for changes in cognitive
functioning
Secondary outcome
The secundary study parameters are the biological data (MRI, genetics),
behavioral data (Pre Pulse Inhibition) and environmental data (cannabis use)
that are linked to the cognitive data. In this manner potential predisposing
factors for cognitive functioning can be identified.
Background summary
Cognitive deficits (problems with thinking abilities, such as learning, memory
and attention) are core features of schizophrenia and may be major determinants
of social and occupational functioning. Thus far, there has been a lack of
effective treatments for these deficits. TURNS is a NIMH-funded contract to
evaluate new compounds for the treatment of cognitive impairment in
schizophrenia. TURNS is the 2nd part of an initiative (followed by a study
called MATRICS * Measurement and Treatment Research to Improve Cognition in
Schizophrenia) from the NIMH and the FDA to reach a consensus on standards of
measurement for cognition and clinical trials design. In the MATRICS study, a
standardized cognitive test battery was developed for use in the TURNS study.
In the proposed TIP University of Amsterdam project the intention is to assess
cognitive and functional deficits in four groups: subjects running a High Risk
of developing schizophrenia-like psychoses (HR subjects) and First-Episode
patients with schizophrenia-like psychoses who are either cannabis users or
non-users, as well as the potential predictive validity of genetic and other
biomarkers.
Study objective
1. How is the development of cognition over the time period of one year,
assessed by the MATRICS cognitive test battery, in a study population of First
Episode Schizophrenia patients and Ultra High Risk subjects?
2. What is the potential predictive value of biomarkers (genetics, structural
MRI), behavioral (Pre Pulse Inhibiting) and environmental factors (cannabis
use) for cognitive functioning after one year
Study design
This is a case control study with two patient populations and a control group.
Participants will be requested to come to the psychiatry ward of the AMC for 1
day at T0 and half a day at T2
The participants will be subjected to the following tests:
T=O:
- Intake: psychological tests as screening instruments for psychopathology
(PANSS, CASH), somatical history, basic physical examination, time: 1.5 hours
- MATRICS test battery, time: 1.5 hours
- MRI scan, time: 30 minutes
- Pre Pulse Inhibiting research (PPI), time: 15 minutes
- Venal punction 20 ml and testing for cannabis in the urine, time: 20 minutes
T=1:
- MATRICS test battery, time 1.5 hours
- PANSS, time 45 minutes
Timetable:
The study will be performed between august 2007 and july 2010
aug* 07 - dec *07: - translating MATRICS test battery and performing PILOT
study, recruitment of subjects
jan - juli *08: - T0 measurements in patients and healthy controls
aug - dec *08: - training in the molecular genetic laboratory and performing
genetic research
juli *09: - T1 measurements in patients and healthy controls
aug *09 - juli*10 - analysing of data
Study burden and risks
Participating in this study has minimal risks for the participants. The risks
are those related to a venal punction (haematoma or, very rare, vasovagal
collaps) and the making of an MRI scan without the use of any contrast. All
participants will we screened for the presence of metals in the body, pregnancy
and potential fears (claustrofobia) or bad experiences with MRI investigation.
There is no direct benefit in participating for the patients, but participating
will contribute to more knowledge about schizophrenia and High Risk subjects.
There is no group relatedness, all participants receive the same treatment.
Meibergdreef 5
1105 AZ
NL
Meibergdreef 5
1105 AZ
NL
Listed location countries
Age
Inclusion criteria
The First Episode Schizophrenia patients will have to meet the DSM-IV criteria for schizophrenia and this diagnosis should not have been assessed in the past.
The Ultra High Risk patients will be assessed using the Structured Interview of Prodromal Symptoms (SIPS) and
Exclusion criteria
pregnancy,
metals in the body contraindicated in MRI inverstigation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
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CCMO | NL19591.018.07 |