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

This study has been completed.
Sponsor:
Collaborators:
Bispebjerg Hospital
Research Unit, Psyciatric Centre Bispebjerg
Research Institute of Biological Psychiatry,Psychiatric Centre Sct. Hans
Danish Centre for Health Technology Assessment
Ministry of Health and Prevention; Denmark
TrygFonden, Denmark
Information provided by (Responsible Party):
Gesche Jurgens, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00707382
First received: June 26, 2008
Last updated: February 9, 2012
Last verified: February 2012

June 26, 2008
February 9, 2012
February 2008
December 2011   (final data collection date for primary outcome measure)
Time to discontinuation of initial antipsychotic treatment [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00707382 on ClinicalTrials.gov Archive Site
Compliance [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Genotyping for CYP450 Polymorphisms Versus Intense Clinical Monitoring on Antipsychotic Drug Treatment
A Three-armed Randomised Controled Trial on the Effect of Genotyping for CYP450 Polymorphisms and 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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Schizophrenia
  • 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.
  • 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.
    Intervention: Genetic: (1) Genotyping for CYP4502D6 and 2C19 polymorphisms
  • (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.
    Intervention: Other: (2) Intense clinical monitoring
  • No Intervention: (3) Control
    In this studyarm (3), (Control) treatment followed usual local practice. The genotype information was not revealed.
    Intervention: Other: (3) Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
311
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosed with schizophrenia
  • Able to give written informed consent

Exclusion Criteria:

  • Genotyped prior to inclusion
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00707382
H-D-2007-0056
No
Gesche Jurgens, Bispebjerg Hospital
Gesche Jurgens
  • Bispebjerg Hospital
  • Research Unit, Psyciatric Centre Bispebjerg
  • Research Institute of Biological Psychiatry,Psychiatric Centre Sct. Hans
  • Danish Centre for Health Technology Assessment
  • Ministry of Health and Prevention; Denmark
  • TrygFonden, Denmark
Principal Investigator: Gesche Jürgens, MD, phd Department of Clinical Pharmacology, Bispebjerg University Hospital
Bispebjerg Hospital
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP