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

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

Conditions

• Schizophrenia

Interventions

GENETIC

(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 according to local guidelines. 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.

OTHER

(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.

OTHER

(3) Control

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

Sponsors & Collaborators

• Bispebjerg Hospital

  collaborator OTHER

• Research Unit, Psyciatric Centre Bispebjerg

  collaborator UNKNOWN

• Research Institute of Biological Psychiatry,Psychiatric Centre Sct. Hans

  collaborator UNKNOWN

• Danish Centre for Health Technology Assessment

  collaborator OTHER

• The Ministry of Health and Prevention, Denmark

  collaborator OTHER_GOV

• TrygFonden, Denmark

  collaborator INDUSTRY

• Gesche Jurgens

  lead OTHER

Principal Investigators

• Gesche Jürgens, MD, phd · Department of Clinical Pharmacology, Bispebjerg University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-02-29

Primary Completion

2011-12-31

Completion

2011-12-31

Countries

• Denmark

Study Locations