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Completed

NCT Number: NCT00707382

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

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

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Key information

Conditions

Schizophrenia Behavior Health Behavior Mental Disorders Patient Acceptance of Health Care Patient Compliance Schizophrenia Spectrum and Other Psychotic Disorders Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Pharmacology, Bispebjerg Hospital and Research Unit, Psychiatric Centre Bispebjerg

Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with schizophrenia
  • Able to give written informed consent

Exclusion criteria

  • Genotyped prior to inclusion

Treatment and study plan

(1) Genotyping for CYP4502D6 and 2C19 polymorphisms

Genetic

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.

(2) Intense clinical monitoring

Other

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

Other

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

Primary outcomes

  1. Time to discontinuation of initial antipsychotic treatment

    Time frame: one year

Secondary outcomes

  1. Compliance

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Gesche Jurgens

Other

Collaborators

  • Bispebjerg Hospital
  • Danish Centre for Health Technology Assessment
  • Research Institute of Biological Psychiatry,Psychiatric Centre Sct. Hans
  • Research Unit, Psyciatric Centre Bispebjerg
  • The Ministry of Health and Prevention, Denmark
  • TrygFonden, Denmark

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jun 30, 2008
Registry last updated
Feb 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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