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
  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: Double Blind (Subject, Caregiver, 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 Bispebjerg Hospital:

Primary Outcome Measures:
  • Time to discontinuation of initial antipsychotic treatment [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compliance [ Time Frame: one year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Ministry of Health and Prevention; Denmark
TrygFonden, Denmark
Investigators
Principal Investigator: Gesche Jürgens, MD, phd Department of Clinical Pharmacology, Bispebjerg University Hospital
  More Information

No publications provided

Responsible Party: Gesche Jurgens, MD, PhD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT00707382     History of Changes
Other Study ID Numbers: H-D-2007-0056
Study First Received: June 26, 2008
Last Updated: February 9, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Bispebjerg Hospital:
Pharmacogenetics
Compliance
Antipsychotic drugs
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 20, 2014