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

Gesche Jurgens

Status: Completed

Conditions: Schizophrenia

Treatments: Other: (2) Intense clinical monitoring; Other: (3) Control; Genetic: (1) Genotyping for CYP4502D6 and 2C19 polymorphisms

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00707382

H-D-2007-0056

Details and patient eligibility

About

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

Enrollment: 311 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with schizophrenia
• Able to give written informed consent

Exclusion criteria

• Genotyped prior to inclusion

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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311 participants in 3 patient groups

Genotyping for CYP4502D6 and 2C19 polymorphisms

Other group

Description:

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.

Treatment:

Genetic: (1) Genotyping for CYP4502D6 and 2C19 polymorphisms

(2) Intense clinical monitoring

Other group

Description:

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.

Treatment:

Other: (2) Intense clinical monitoring

(3) Control

No Intervention group

Description:

In this studyarm (3), (Control) treatment followed usual local practice. The genotype information was not revealed.

Treatment:

Other: (3) Control