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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00707382
First Posted: June 30, 2008
Last Update Posted: February 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Bispebjerg Hospital
Research Unit, Psyciatric Centre Bispebjerg
Research Institute of Biological Psychiatry,Psychiatric Centre Sct. Hans
Danish Centre for Health Technology Assessment
The Ministry of Health and Prevention, Denmark
TrygFonden, Denmark
Information provided by (Responsible Party):
Gesche Jurgens, Bispebjerg Hospital
  Purpose

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

Condition Intervention
Schizophrenia Genetic: (1) Genotyping for CYP4502D6 and 2C19 polymorphisms Other: (2) Intense clinical monitoring Other: (3) Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Three-armed Randomised Controled Trial on the Effect of Genotyping for CYP450 Polymorphisms and Intense Clinical Monitoring on Antipsychotic Drug Treatment.

Resource links provided by NLM:


Further study details as provided by Gesche Jurgens, Bispebjerg Hospital:

Primary Outcome Measures:
  • Time to discontinuation of initial antipsychotic treatment [ Time Frame: one year ]

Secondary Outcome Measures:
  • Compliance [ Time Frame: one year ]

Enrollment: 311
Study Start Date: February 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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
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
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
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.
No Intervention: (3) Control
In this studyarm (3), (Control) treatment followed usual local practice. The genotype information was not revealed.
Other: (3) Control
In this studyarm (3), (Control) treatment followed usual local practice. The genotype information was not revealed.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with schizophrenia
  • Able to give written informed consent

Exclusion Criteria:

  • Genotyped prior to inclusion
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00707382


Locations
Denmark
Department of Clinical Pharmacology, Bispebjerg Hospital and Research Unit, Psychiatric Centre Bispebjerg
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Gesche Jurgens
Bispebjerg Hospital
Research Unit, Psyciatric Centre Bispebjerg
Research Institute of Biological Psychiatry,Psychiatric Centre Sct. Hans
Danish Centre for Health Technology Assessment
The Ministry of Health and Prevention, Denmark
TrygFonden, Denmark
Investigators
Principal Investigator: Gesche Jürgens, MD, phd Department of Clinical Pharmacology, Bispebjerg University Hospital
  More Information

Responsible Party: Gesche Jurgens, MD, PhD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT00707382     History of Changes
Other Study ID Numbers: H-D-2007-0056
First Submitted: June 26, 2008
First Posted: June 30, 2008
Last Update Posted: February 10, 2012
Last Verified: February 2012

Keywords provided by Gesche Jurgens, Bispebjerg Hospital:
Pharmacogenetics
Compliance
Antipsychotic drugs
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs