SchizophreniaNCT00161057
Functional Brain Activation Patterns in Schizophrenia, Measured Before and After Treatment
An observational study of Schizophrenia and Schizophreniform Disorders, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
In this study we, the investigators at UMC Utrecht, intend to investigate changes in brain activation patterns using functional magnetic resonance imaging (MRI), in patients suffering from schizophrenia who are medication naive or off medication, before using medication and after 8 weeks of medication. Read more about this study
- Who is it for?
- Ages 16 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Schizophreniform Disorders
- How many people
- 78 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2001to Sep 2008
- 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 16 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: first episode schizophrenia patients, medication naive (or medication-free) and matched healthy controls.
Who may be able to join
- Diagnoses of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS, confirmed on the basis of Comprehensive Assessment of Symptoms and History (CASH) or a Structured Clinical Interview for DSM-IV Disorders (SCID) interview
- Ages between 16 and 50 years
- CGI of at least 4
- Patients are neuroleptic-naive or medication-free for at least 2 weeks
- No psychiatric disorders (according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition [DSM-IV], Axis I)
- No psychiatric disorders in first degree relatives.
- Ages: between 18 and 50 years old
Who cannot join
- Ferrous objects in or around the body
- Neurological or medical illness, including closed head injury.
- Mental retardation.
- Diagnosis of substance dependence within the previous 3 months.
- Pregnancy
- Treatment with antidepressants or mood stabilizers within 3 weeks of inclusion.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Dept. of Psychiatry, UMC Utrecht
Utrecht, Utrecht, 3584 CX
About this study
In this study we, the investigators at UMC Utrecht, intend to investigate changes in brain activation patterns using functional magnetic resonance imaging (MRI), in patients suffering from schizophrenia who are medication naive or off medication, before using medication and after 8 weeks of medication. Patients will perform a working memory task, a language task and a motor task while lying in the scanner. We hypothesize that the efficiency of the working memory system is reduced and that the lateralization of language is diminished in these patients, and that these functions will normalize after treatment.
Read the detailed description
Schizophrenia is a heterogeneous disorder with a wide range of symptoms and signs including hallucinations, delusions, disorganisation, negative symptoms and cognitive deficits. Investigation of the neural substrates of the cognitive deficits in schizophrenia has revealed abnormalities in brain activity patterns. Particularly, earlier studies using functional FMRI conducted at the UMCU, revealed diminished language laterality, deficits in working memory and a reduced ability to automate cognitive processes. The aim of this project is to study the relationship between these brain activation patterns and neuroleptic treatment. More insight into psychopharmacological effects on brain physiology, may eventually enable us to better predict what effect treatment will have on patients.
Patients with a confirmed diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder not otherwise specified (NOS), who are medication naive or medication free for a period of at least 2 weeks will be included. Patients will be tested before and after 8 weeks of treatment with an atypical antipsychotic. In the scanner patients will perform a working memory task, a language task and a visual-motor task. At study entry and after 8 weeks the PANSS, Clinical Global Impressions (CGI) and CDSS (Calgary Depression Scale of Schizophrenia) will be performed. Besides these patients, we will also include a group of matched healthy controls. We hypothesize that in medication naive or patients of-medication lateralization is reduced, and that efficiency of the working memory system is reduced. Lateralization is expected to correlate negatively with positive functions. We expect that antipsychotic treatment will normalize brain function and that the degree of normalization is correlated with the clinical measures of treatment efficacy.
- Conditions
- Schizophrenia, Schizophreniform Disorders
- Keywords
- Schizophrenia, Medication-naive, Functional MRI, Working memory, Language lateralization, schizoaffective disorder, psychotic disorder Not Otherwise Specified
- Medical subject headings
- Schizophrenia, Psychotic Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startDec 2001
- Study completionSep 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Investigators
- Nicoletta V Veelen, Principal investigator, UMC UtrechtRene Kahn, M.D. Ph.D., Study chair, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161057
- Sponsor's protocol ID
- METC 01/134
- Status last verified
- Apr 2009
- First submitted
- 8 Sep 2005
- Last updated
- 23 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Brain Activation Patterns in Schizophrenia, Measured Before and After Treatment
- ClinicalTrials.gov ID
- NCT00161057
- Acronym / sponsor ID
- METC 01/134
- Conditions
- Schizophrenia, Schizophreniform Disorders
- Keywords
- Schizophrenia, Medication-naive, Functional MRI, Working memory, Language lateralization, schizoaffective disorder, psychotic disorder Not Otherwise Specified
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Dec 2001
- Study completion
- Sep 2008 (actual)
- First posted
- 12 Sep 2005 (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.
In this study we, the investigators at UMC Utrecht, intend to investigate changes in brain activation patterns using functional magnetic resonance imaging (MRI), in patients suffering from schizophrenia who are medication naive or off medication, before using medication and after 8 weeks of medication. Patients will perform a working memory task, a language task and a motor task while lying in the scanner. We hypothesize that the efficiency of the working memory system is reduced and that the lateralization of language is diminished in these patients, and that these functions will normalize after treatment.
Detailed description
Schizophrenia is a heterogeneous disorder with a wide range of symptoms and signs including hallucinations, delusions, disorganisation, negative symptoms and cognitive deficits. Investigation of the neural substrates of the cognitive deficits in schizophrenia has revealed abnormalities in brain activity patterns. Particularly, earlier studies using functional FMRI conducted at the UMCU, revealed diminished language laterality, deficits in working memory and a reduced ability to automate cognitive processes. The aim of this project is to study the relationship between these brain activation patterns and neuroleptic treatment. More insight into psychopharmacological effects on brain physiology, may eventually enable us to better predict what effect treatment will have on patients.
Patients with a confirmed diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder not otherwise specified (NOS), who are medication naive or medication free for a period of at least 2 weeks will be included. Patients will be tested before and after 8 weeks of treatment with an atypical antipsychotic. In the scanner patients will perform a working memory task, a language task and a visual-motor task. At study entry and after 8 weeks the PANSS, Clinical Global Impressions (CGI) and CDSS (Calgary Depression Scale of Schizophrenia) will be performed. Besides these patients, we will also include a group of matched healthy controls. We hypothesize that in medication naive or patients of-medication lateralization is reduced, and that efficiency of the working memory system is reduced. Lateralization is expected to correlate negatively with positive functions. We expect that antipsychotic treatment will normalize brain function and that the degree of normalization is correlated with the clinical measures of treatment efficacy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- first episode schizophrenia patients, medication naive (or medication-free) and matched healthy controls.
Key inclusion criteria (7 listed)
- Diagnoses of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS, confirmed on the basis of Comprehensive Assessment of Symptoms and History (CASH) or a Structured Clinical Interview for DSM-IV Disorders (SCID) interview
- Ages between 16 and 50 years
- CGI of at least 4
- Patients are neuroleptic-naive or medication-free for at least 2 weeks
- No psychiatric disorders (according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition [DSM-IV], Axis I)
Key exclusion criteria (6 listed)
- Ferrous objects in or around the body
- Neurological or medical illness, including closed head injury.
- Mental retardation.
- Diagnosis of substance dependence within the previous 3 months.
- Pregnancy
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
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 23 Apr 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.
Nicoletta V Veelen principal investigator
UMC Utrecht
Rene Kahn, M.D. Ph.D. study chair
UMC Utrecht
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 and Schizophreniform Disorders, run by UMC Utrecht at 1 site in Netherlands.
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 7 inclusion and 6 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 23 Apr 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 Netherlands. 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?
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.
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 23 Apr 2009.