Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00161135
Other study ID # WOM 98/261
Secondary ID
Status Completed
Phase N/A
First received September 8, 2005
Last updated April 19, 2007
Start date January 1999

Study information

Verified date April 2007
Source UMC Utrecht
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Observational

Clinical 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. We hypothesize that subjects with autism will have larger brains than controls, whereas subjects with MCDD will have smaller brains.


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 7 Years to 24 Years
Eligibility Inclusion Criteria:

- Diagnosis of autism according to ADI-interview or diagnosis of MCDD according to the MCDD-checklist or no psychiatric diagnosis (controls)

Exclusion Criteria:

- 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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands Dept. of Child and Adolescent Psychiatry, UMC Utrecht Utrecht

Sponsors (1)

Lead Sponsor Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View Citation

Palmen 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. — View Citation

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05302167 - Molehill Mountain Feasibility Study. N/A
Completed NCT04167839 - Effects of Sensory Diets on Children's Sensory Processing Skills, Psychosocial Skills, and Classroom Engagement N/A
Terminated NCT04049981 - Investigation of Mechanisms of Action in Superpower Glass Phase 1/Phase 2
Active, not recruiting NCT06080087 - Implementation Toolkit to Enhance EBP Among Marginalized Families N/A
Recruiting NCT04107064 - Achieving Steady Work Among Adults With Autism Through Specialized Employment Program N/A
Completed NCT03206996 - Exposure Therapy for Auditory Sensitivity in Autism N/A
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Completed NCT05588570 - Coaching Children With Anxiety and Autism Through Telehealth N/A
Enrolling by invitation NCT06058104 - Evaluating Efficacy of a Digital Game Therapeutic for Children With Autism N/A
Completed NCT02847182 - Cord Blood Infusion for Children With Autism Spectrum Disorder Phase 2
Completed NCT03002363 - The Effects of Video Modeling of Audiological Testing on Pediatric Patient Compliance Phase 1
Completed NCT02911194 - a2 Milk for Autism and Attention-deficit Hyperactivity Disorder (ADHD) N/A
Withdrawn NCT02414451 - Trial of Propranolol in Adults and Adolescents With ASD and Predictors of Response N/A
Completed NCT02708290 - Mental Imagery Therapy for Autism (MITA) - an Early Intervention Computerized Language Training Program for Children With ASD
Completed NCT02536365 - Sensory Integration Therapy in Autism: Mechanisms and Effectiveness N/A
Completed NCT02508922 - Trial of Vitamin D3 Supplementation in Paediatric Autism N/A
Completed NCT02720900 - Prebiotic Intervention for Autism Spectrum Disorders N/A
Recruiting NCT01836562 - A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Autism Phase 1/Phase 2
Recruiting NCT02255565 - Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study Phase 4
Completed NCT02154828 - Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)