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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01253993
Other study ID # 05-271
Secondary ID ZonMw 31100001NI
Status Completed
Phase Phase 0
First received March 2, 2007
Last updated December 3, 2010
Start date April 2006
Est. completion date September 2007

Study information

Verified date December 2010
Source UMC Utrecht
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Observational

Clinical Trial Summary

There is clear evidence that aggressive behavior and disruptive behavior disorders (DBD) in middle childhood are associated with an increased risk for substance abuse in adolescence. However, the exact underlying mechanism of this increased risk is unknown. It is likely that a biopsychological vulnerability in some aggressive children and children with DBD makes them liable to substance use and abuse. The investigators hypothesize that deficient decision making is such a biopsychological factor. In this study the investigators aim to test the latter hypothesis by investigating the decision making ability in a group of adolescents with DBD with and without substance use disorders. Decision-making is assessed with the IOWA Gambling Task (GT). This task mimics real-life situations in the way it factors uncertainty, reward and punishment. The GT is specifically designed to assess impaired decision-making in individuals who are unable to learn from their mistakes and make decisions that repeatedly lead to negative consequences. This characteristic may be common to individuals with externalizing disorders such as DBD, psychopathy, and substance use disorders.


Description:

This study consists of two substudies with adolescents in the age of 14-21 years. The first study group consist of adolescents with DBD with (n=30) and without (n=30) substance use disorders. These adolescents are recruited from orthopsychiatric, forensic psychiatric, and judicial institutions.

The second study group consists of a) ex-patients of the Utrecht Coping Power Program (UCPP)who previously participated to a follow-up study, and b) ex-patients who were treated as a child at an outpatient clinic of the UMC Utrecht. These latter groups were taken together and subdivided into a group with (n=30) and without (n=30) substance use problems.

For both studies healthy controls (n=80) are recruited. The investigators will start with healthy controls from earlier studies, and those are extented and will serve as control group for both studies.


Recruitment information / eligibility

Status Completed
Enrollment 152
Est. completion date September 2007
Est. primary completion date June 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 14 Years to 21 Years
Eligibility Inclusion Criteria:

- Having a DISC diagnosis DBD

Exclusion Criteria:

- Having the DISC diagnosis Schizophrenia

Study Design

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


Locations

Country Name City State
Netherlands University Medical Center Utrecht Utrecht

Sponsors (3)

Lead Sponsor Collaborator
UMC Utrecht National Institute on Drug Abuse (NIDA), ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Ernst M, Grant SJ, London ED, Contoreggi CS, Kimes AS, Spurgeon L. Decision making in adolescents with behavior disorders and adults with substance abuse. Am J Psychiatry. 2003 Jan;160(1):33-40. — View Citation

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