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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00707382
• Other study ID #: H-D-2007-0056
• Status: Completed
• Phase: N/A
• First received: June 26, 2008
• Last updated: February 9, 2012
• Start date: February 2008
• Est. completion date: December 2011

Study information

• Verified date: February 2012
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with schizophrenia

• Able to give written informed consent

Exclusion Criteria:

• Genotyped prior to inclusion

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Clinical Pharmacology, Bispebjerg Hospital and Research Unit, Psychiatric Centre Bispebjerg	Copenhagen

Sponsors (7)

Lead Sponsor	Collaborator
Gesche Jurgens	Bispebjerg Hospital, Danish Centre for Health Technology Assessment, Ministry of Health and Prevention; Denmark, Research Institute of Biological Psychiatry,Psychiatric Centre Sct. Hans, Research Unit, Psyciatric Centre Bispebjerg, TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to discontinuation of initial antipsychotic treatment		one year	No
Secondary	Compliance		one year	No