Elevated elimination rates of quetiapine in adolescent patients with schizophrenia (ICD 10: F 20.-), bipolar affective disorder (ICD 10: F 31.-), disorders in impulse control with current PTSD (ICD 10: F 43.1) or personality disorder (ICD 10: F 60.-):clinical trial for genotypying of two metabolizing enzymes (CYP2D6 und CYP3A5*3).(Erhöhte Eliminationsraten von Quetiapin bei jugendlichen Patienten mit Schizophrenie (ICD 10: F 20.-), bipolar affektiver Störung (ICD 10: F 31.-) bzw. Störung der Impulskontrolle bei vorliegender PTBS (ICD 10: F 43.1) oder Persönlichkeitsstörung (ICD 10: F 60.-):Klinische Studie zur Genotypisierung zweier metabolisierender Enzyme (CYP2D6 und CYP3A5*3).)

• Conditions: schizophrenia (ICD 10: F 20.-), bipolar affective disorder (ICD 10: F 31.-), disorders of impulse control with current PTSD (ICD 10: F 43.1) or personality disorder (ICD 10: F 60.-).

• Registration Number: EUCTR2007-005716-64-AT
• Lead Sponsor: niversitätsklinik für Psychiatrie des Kindes- und Jugendalters, AKH Wien, Medizinische Universität

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-25
• Last Update Posted: 4 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Male and female adolescents between 14 and 20 years of age with schizophrenia (ICD 10: F 20.-), bipolar affective disorder (ICD 10: F 31.-), disorders of impulse control with current PTSD (ICD 10: F 43.1) or personality disorder (ICD 10: F 60.-), who have been admitted to the Department of Child and Adolescent Psychiatry, Medical University Vienna. Although being treated with dosage of Quetiapine within therapeutical levels, the adolescents show drug levels of Quetiapine below the therapeutical range (70-170 ng/ml).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The adolescents will also be inluded in the study if they take co-medication. Nevertheless, the interactions or side effects with the following co-medications will be observed precisely: phenytoine, divalproex, thioridazine, cimetidine, P450 inhibitors (especially ketoconazole), fluoxetine, imipramine, haloperidol und risperidone.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Adolescent patients (at the Department of Child and Adolescent Psychiatry, Medical University Vienna) with schizophrenia (ICD 10: F 20.-), bipolar affective disorder (ICD 10: F 31.-), disorders of impulse control with current PTSD (ICD 10: F 43.1) or personality disorder (ICD 10: F 60.-), who have significantly elevated elimination rates of their medication Seroquel, should be examined.<br>The aim of the study is to find genetic polymorphisms for two metabolizing enzymes -CYP2D6 und CYP3A5*3 - which could be responsible for the elevated elimination rates. Midazolam will be used as a test substance for phenotyping the enzyme system.<br>;Secondary Objective: ;Primary end point(s):