Effect of Genotyping for CYP450 Polymorphisms Versus Intense Clinical Monitoring on Antipsychotic Drug Treatment

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Genetic: (1) Genotyping for CYP4502D6 and 2C19 polymorphisms; Other: (2) Intense clinical monitoring; Other: (3) Control

• Registration Number: NCT00707382
• Lead Sponsor: Gesche Jurgens

Brief Summary

The purpose of this study is to determine whether genotyping for CYP2D6 and 2C19 polymorphisms or intense clinical monitoring of treatment and adverse effects improves the antipsychotic treatment in patients with schizophrenia. This study is designed as a three-armed prospective randomized controlled clinical trial and includes 300 patients with schizophrenia. Patients are followed for a period of one year.

During the study period the following effect measures are registered:

* Time to discontinuation of all antipsychotic medications

* Number of changes in medication dose

* Number of changes in medication

* Compliance (patients´ adherence to medical treatment)

* Clinical symptoms

* Adverse effects

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-06-26
• Study First Submitted QC: 2008-06-27
• Study First Posted: 2008-06-30
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-09
• Last Update Posted: 2012-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 311

Inclusion Criteria

• Diagnosed with schizophrenia
• Able to give written informed consent

Exclusion Criteria

• Genotyped prior to inclusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Genotyping for CYP4502D6 and 2C19 polymorphisms	(1) Genotyping for CYP4502D6 and 2C19 polymorphisms	In this study arm (1) the genotype information is given to the physician in charge of treatment and can be used to direct the pharmacological treatment in accordance with the current guidelines from Sct. Hans hospital. In the guidelines the genotype is translated to the clinical designation "normal", "slow" or "fast" metabolizer of CYP2D6 or "normal" or "slow" metabolizer of CYP2C19. Different treatment options for the different genotypes are described in the clinical guidelines.
(2) Intense clinical monitoring	(2) Intense clinical monitoring	In this study arm (2) the genotype information is not revealed. The intervention consists of an intensified clinical monitoring of treatment effect, side effects and patient perspective. Staffpersonnel is trained in the use of a clinical manual that builds on a selection of validated questions from the Scale for the Assessment of Positive Symptoms (SAPS), Side effect score (Udvalg af Kliniske Undersøgelser (UKU) and Rating of Medical Influences (ROMI). The manual has to be used at least once in a quarter (every third month), which is monitored by the study personnel. Data registered by the patients primary contact person are not used as outcome measures in the study but only as intervention tool for the optimisation of the medical antipsychotic treatment.
(3) Control	(3) Control	In this studyarm (3), (Control) treatment followed usual local practice. The genotype information was not revealed.

Primary Outcome Measures

Name	Time	Method
Time to discontinuation of initial antipsychotic treatment	one year

Secondary Outcome Measures

Name	Time	Method
Compliance	one year

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Bispebjerg Hospital and Research Unit, Psychiatric Centre Bispebjerg; 🇩🇰 Copenhagen, Denmark