AutismNCT00161135
Magnetic Resonance Imaging in Children and Adolescents With Autism and Multiple Complex Developmental Disorders
An observational study of Autism and Developmental Disabilities, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
This study aims to investigate the overlap and differences between autism and MCDD as neuropsychiatric childhood disorders. MRI scans are acquired from subjects with autism, subjects with a diagnosis of MCDD and typically developing controls. Volumetric measure of various brain regions are compared between groups. Read more about this study
- Who is it for?
- Ages 7 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism, Developmental Disabilities
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 1999to 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 7 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Diagnosis of autism according to ADI-interview or diagnosis of MCDD according to the MCDD-checklist or no psychiatric diagnosis (controls)
Who cannot join
- Some medical and neurological diseases (if there are influences on the brain structures)
- Alcohol or drug abuse
- IQ < 70
- Focal abnormalities on the MRI scan
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Dept. of Child and Adolescent Psychiatry, UMC Utrecht
Utrecht, 3584CX
About this study
This study aims to investigate the overlap and differences between autism and MCDD as neuropsychiatric childhood disorders. MRI scans are acquired from subjects with autism, subjects with a diagnosis of MCDD and typically developing controls. Volumetric measure of various brain regions are compared between groups. We hypothesize that subjects with autism will have larger brains than controls, whereas subjects with MCDD will have smaller brains.
Read the detailed description
Autism and Childhood-onset Schizophrenia have been clearly defined as neuropsychiatric disorders since the studies of Kolvin and Rutter. In the early seventies the discussion on a possible overlap between the two types of disorders vanished, but nowadays this issue revives. Amongst all the advances of the DSM diagnostic criteria, the omission of developmental information appears to be a disadvantage. The Pervasive Developmental Spectrum is a broad spectrum, that with exceptions for Autism and some other characteristic disorders, to a large extent consists of an ill-defined restcategory. Most patients actually belong to this last category , the so-called PDD-NOS group. In recent years more has been published about the subgroups within this large group. One of these subgroups, the Multiple Complex Developmental Disorder (MCDD), appears to be a well defined category of patients whose validity has been confirmed by research. In adulthood, a large percentage of this MCDD group seems to develop Schizophrenia or a Schizophrenia related disorder. This again does arise the question of a possible overlap. This discussion is even emphasized by reports notably on -mostly retrospective- studies of premorbid autistic features in patients with Schizophrenia.
In the present day studies on neurodevelopmental psychiatric disorders, there is a search for biological markers or discriminating factors. One of the applied methods is structural imaging. Question marks can be placed on the differing study set-ups and protocols which seriously hinder their inter alia comparison. However one can still conclude that the results of studies on subjects with Autism and Childhood-onset Schizophrenia reveal major differences. However, structural abnormalities do not tell anything about possible functional abnormalities. But detecting structural abnormalities can be helpful in forming hypothesis about the origin of these neurodevelopmental disorders.
In this study brain structures will be measured by magnetic resonance imaging. Structural deviances will be interpreted as a reflection of functional abnormalities. It is hypothesized that the abnormalities on structural imaging in MCDD patients will more resemble the abnormalities found in the literature for (Childhood-onset) Schizophrenia instead of the deviances revealed in subjects with Autism.
In this study patients with Autism and MCDD will be divided in two groups: before and after puberty. Each group will behold 15-40 subjects. They each will be compared with two groups of 20-25 age, sex and IQ matched controls. They will participate in carrying out a MRI scan, filling in some questionnaires and if necessary an IQ test and a general physical examination.The MRI scans will be measured, and compared with each other in order to find 'disorder-specific' abnormalities.
- Conditions
- Autism, Developmental Disabilities
- Keywords
- MRI, PDD-NOS, MCDD
- Medical subject headings
- Autistic Disorder, Developmental Disabilities
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 startJan 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Investigators
- Bertine E Lahuis, M.D., Principal investigator, Rudolf Magnus Institute of Neuroscience, University Medical Center UtrechtSarah Durston, Ph.D., Study director, Rudolf Magnust Institute of Neuroscience, UMC UtrechtHerman van Engeland, M.D. Ph.D., Study chair, Rudolf Magnus Institute of Neuroscience, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161135
- Sponsor's protocol ID
- WOM 98/261
- Status last verified
- Apr 2007
- First submitted
- 8 Sep 2005
- Last updated
- 20 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Palmen SJ, Hulshoff Pol HE, Kemner C, Schnack HG, Durston S, Lahuis BE, Kahn RS, Van Engeland H. Increased gray-matter volume in medication-naive high-functioning children with autism spectrum disorder. Psychol Med. 2005 Apr;35(4):561-70. doi: 10.1017/s0033291704003496.
PubMed 15856726Palmen SJ, Hulshoff Pol HE, Kemner C, Schnack HG, Janssen J, Kahn RS, van Engeland H. Larger brains in medication naive high-functioning subjects with pervasive developmental disorder. J Autism Dev Disord. 2004 Dec;34(6):603-13. doi: 10.1007/s10803-004-5282-2.
PubMed 15679181
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging in Children and Adolescents With Autism and Multiple Complex Developmental Disorders
- ClinicalTrials.gov ID
- NCT00161135
- Acronym / sponsor ID
- WOM 98/261
- Conditions
- Autism, Developmental Disabilities
- Keywords
- MRI, PDD-NOS, MCDD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Jan 1999
- 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.
This study aims to investigate the overlap and differences between autism and MCDD as neuropsychiatric childhood disorders. MRI scans are acquired from subjects with autism, subjects with a diagnosis of MCDD and typically developing controls. Volumetric measure of various brain regions are compared between groups. We hypothesize that subjects with autism will have larger brains than controls, whereas subjects with MCDD will have smaller brains.
Detailed description
Autism and Childhood-onset Schizophrenia have been clearly defined as neuropsychiatric disorders since the studies of Kolvin and Rutter. In the early seventies the discussion on a possible overlap between the two types of disorders vanished, but nowadays this issue revives. Amongst all the advances of the DSM diagnostic criteria, the omission of developmental information appears to be a disadvantage. The Pervasive Developmental Spectrum is a broad spectrum, that with exceptions for Autism and some other characteristic disorders, to a large extent consists of an ill-defined restcategory. Most patients actually belong to this last category , the so-called PDD-NOS group. In recent years more has been published about the subgroups within this large group. One of these subgroups, the Multiple Complex Developmental Disorder (MCDD), appears to be a well defined category of patients whose validity has been confirmed by research. In adulthood, a large percentage of this MCDD group seems to develop Schizophrenia or a Schizophrenia related disorder. This again does arise the question of a possible overlap. This discussion is even emphasized by reports notably on -mostly retrospective- studies of premorbid autistic features in patients with Schizophrenia.
In the present day studies on neurodevelopmental psychiatric disorders, there is a search for biological markers or discriminating factors. One of the applied methods is structural imaging. Question marks can be placed on the differing study set-ups and protocols which seriously hinder their inter alia comparison. However one can still conclude that the results of studies on subjects with Autism and Childhood-onset Schizophrenia reveal major differences. However, structural abnormalities do not tell anything about possible functional abnormalities. But detecting structural abnormalities can be helpful in forming hypothesis about the origin of these neurodevelopmental disorders.
In this study brain structures will be measured by magnetic resonance imaging. Structural deviances will be interpreted as a reflection of functional abnormalities. It is hypothesized that the abnormalities on structural imaging in MCDD patients will more resemble the abnormalities found in the literature for (Childhood-onset) Schizophrenia instead of the deviances revealed in subjects with Autism.
In this study patients with Autism and MCDD will be divided in two groups: before and after puberty. Each group will behold 15-40 subjects. They each will be compared with two groups of 20-25 age, sex and IQ matched controls. They will participate in carrying out a MRI scan, filling in some questionnaires and if necessary an IQ test and a general physical examination.The MRI scans will be measured, and compared with each other in order to find 'disorder-specific' abnormalities.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 7 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Diagnosis of autism according to ADI-interview or diagnosis of MCDD according to the MCDD-checklist or no psychiatric diagnosis (controls)
Key exclusion criteria (4 listed)
- Some medical and neurological diseases (if there are influences on the brain structures)
- Alcohol or drug abuse
- IQ < 70
- Focal abnormalities on the MRI scan
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 20 Apr 2007.
- Results publication: PubMed 15856726Palmen SJ, Hulshoff Pol HE, Kemner C, Schnack HG, Durston S, Lahuis BE, Kahn RS, Van Engeland H. Increased gray-matter volume in medication-naive high-functioning children with autism spectrum disorder. Psychol Med. 2005 Apr;35(4):561-70. doi: 10.1017/s0033291704003496.
- Results publication: PubMed 15679181Palmen SJ, Hulshoff Pol HE, Kemner C, Schnack HG, Janssen J, Kahn RS, van Engeland H. Larger brains in medication naive high-functioning subjects with pervasive developmental disorder. J Autism Dev Disord. 2004 Dec;34(6):603-13. doi: 10.1007/s10803-004-5282-2.
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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.
Bertine E Lahuis, M.D. principal investigator
Rudolf Magnus Institute of Neuroscience, University Medical Center Utrecht
Sarah Durston, Ph.D. study director
Rudolf Magnust Institute of Neuroscience, UMC Utrecht
Herman van Engeland, M.D. Ph.D. study chair
Rudolf Magnus Institute of Neuroscience, 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 Autism and Developmental Disabilities, 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 1 inclusion and 4 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 20 Apr 2007. 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?
On the ClinicalTrials.gov record for NCT00161135, which also lists 2 linked publications.
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 20 Apr 2007.