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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).)

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).)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-005716-64-AT
Enrollment
Unknown
Registered
2008-08-25
Start date
2008-08-28
Completion date
Unknown
Last updated
2013-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.-).

Interventions

Trade Name: Seroquel Product Name: Seroquel Pharmaceutical Form: Tablet INN or Proposed INN: Seroquel Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade

Sponsors

Universitätsklinik für Psychiatrie des Kindes- und Jugendalters, AKH Wien, Medizinische Universität
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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. 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. ;Secondary Objective: ;Primary end point(s):—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026