Dutch Prediction of Psychosis Study

Psychotic Disorders Clinical Trial

Official title:

Dutch Prediction of Psychosis Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00188981
• Other study ID #: CCMOP02.0441C
• Secondary ID: METC02/178
• Status: Active, not recruiting
• Phase: N/A
• First received: September 9, 2005
• Last updated: April 19, 2007
• Start date: June 2003
• Est. completion date: June 2008

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

The Dutch Prediction of Psychosis Study (DUPS) is a prospective study of predictors of the transition to psychosis in help-seeking adolescents at high risk for developing a first psychotic episode. The aim of the project is supplemented by a systematic account of the pathways to care, the disabilities and needs and the therapeutic interventions that are currently used in this population.

Multi-level assessment includes behavioral and cognitive variables as well as structural brain imaging and neurophysiological data. Subjects will be followed up at regular intervals during (at least) two years to monitor the development of their (psychotic) symptoms. This will allow us to analyze the predictive validity of the variables.

Description:

The Dutch Prediction of Psychosis Study (DUPS) is a collaboration of the Academic Medical Center in Amsterdam (AMC) and the University Medical Center in Utrecht (UMC). The main objectives are:

1. Pathways to care: the description of the ways subjects at risk for psychosis get access to the health care system and the detection of obstacles to adequate treatment

2. Prediction: the systematic multi-level assessment of predictors of the transition to a first psychotic episode in subjects at risk for psychosis

3. Disability: the description of disabilities, deficits and needs in prodromal individuals

4. Intervention: the description of the therapeutic and preventive interventions applied to prodromal individuals

While the same fundamental principles (e.g. inclusion criteria) are applied in both centers, additional instruments or paradigms are added in the separate centers according to specific interests, expertise and setting.

Our specific interest is in the social cognition and social functioning of prepsychotic individuals. Therefore, in addition to the subjects that are at high risk for psychosis according to the DUPS inclusion/exclusion criteria we are including another group of subjects that is at elevated risk for psychosis, namely subjects who have a Multiple Complex Developmental Disorder (MCDD) which is a subtype of the pervasive developmental disorders.

The study is a prospective longitudinal field-study with repeated measures to monitor subjects at high risk for psychosis.

The study sample in the UMC consists of adolescents who are already referred to adolescent psychiatric outpatient's clinics because of mental problems. After informed consent they are screened for the following inclusion and exclusion criteria:

1. Age between 12 and 18 years

2. No previous psychotic episode for more than one week

3. Verbal IQ above 75

4. Symptoms are not due to an organic mental disorder or substance abuse

5. Belong to one or more of the following groups:

1. Basic symptoms: presence of self-perceived cognitive thought disturbances

2. Familial risk plus reduced functioning: having a first- or second degree relative with a history of any psychotic disorder in combination with a deterioration of mental state and/or social functioning in the last year

3. Attenuated psychotic symptoms: presence of psychotic symptoms at sub-clinical level

4. Brief, limited or intermittent psychotic symptoms: having a history of psychotic symptoms with a duration of less than one week and spontaneous remission

5. Multiple Complex Developmental Disorder

Assessment includes:

1. basic clinical assessment

2. neuropsychological measures (attention, memory, executive functioning)

3. social cognitive measures (facial emotion recognition, mentalizing, social attribution)

4. measures of social cognition and behavior

5. EEG and Event Related Potentials (including smooth pursuit eye movement, auditory mismatch negativity)

6. structural MRI

Some data will be collected retrospectively upon inclusion into the study, for example symptom history and pathways to care. Outcome is assessed after 9, 18 and 24 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

Inclusion criteria:

Help-seeking adolescents who belong to one or more of the following groups:

• Basic symptoms: presence of self-perceived cognitive thought disturbances

• Familial risk plus reduced functioning: having a first- or second degree relative with a history of any psychotic disorder in combination with a deterioration of mental state and/or social functioning in the last year

• Attenuated psychotic symptoms: presence of psychotic symptoms at sub-clinical level

• Brief, limited or intermittent psychotic symptoms: having a history of psychotic symptoms with a duration of less than one week and spontaneous remission

• Multiple Complex Developmental disorder

Exclusion criteria:

• A previous psychotic episode for more than one week

• Verbal IQ < 75

• Symptoms are due to an organic mental disorder or substance abuse

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht, department of Child and Adolescent Psychiatry	Utrecht

Sponsors (3)

Lead Sponsor	Collaborator
UMC Utrecht	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands,