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

Study Overview
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Brief Summary
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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

Official Title
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A Three-armed Randomised Controled Trial on the Effect of Genotyping for CYP450 Polymorphisms and Intense Clinical Monitoring on Antipsychotic Drug Treatment.

Conditions
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Schizophrenia

Intervention / Treatment
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* Genetic: (1) Genotyping for CYP4502D6 and 2C19 polymorphisms
* Other: (2) Intense clinical monitoring
* Other: (3) Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with schizophrenia Able to give written informed consent Exclusion Criteria: Genotyped prior to inclusion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Genotyping for CYP4502D6 and 2C19 polymorphisms<br>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. | Genetic: (1) Genotyping for CYP4502D6 and 2C19 polymorphisms<br>* 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.<br>|
| Other: (2) Intense clinical monitoring<br>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: (2) Intense clinical monitoring<br>* 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.<br>|
| No Intervention: (3) Control<br>In this studyarm (3), (Control) treatment followed usual local practice. The genotype information was not revealed. | Other: (3) Control<br>* In this studyarm (3), (Control) treatment followed usual local practice. The genotype information was not revealed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to discontinuation of initial antipsychotic treatment |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacogenetics, Compliance, Antipsychotic drugs, Schizophrenia