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.
1 other identifier
interventional
311
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started Feb 2008
Typical duration for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 26, 2008
CompletedFirst Posted
Study publicly available on registry
June 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFebruary 10, 2012
February 1, 2012
3.8 years
June 26, 2008
February 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to discontinuation of initial antipsychotic treatment
one year
Secondary Outcomes (1)
Compliance
one year
Study Arms (3)
Genotyping for CYP4502D6 and 2C19 polymorphisms
OTHERIn 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.
(2) Intense clinical monitoring
OTHERIn 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
NO INTERVENTIONIn this studyarm (3), (Control) treatment followed usual local practice. The genotype information was not revealed.
Interventions
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.
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.
In this studyarm (3), (Control) treatment followed usual local practice. The genotype information was not revealed.
Eligibility Criteria
You may qualify if:
- Diagnosed with schizophrenia
- Able to give written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gesche Jurgenslead
- Bispebjerg Hospitalcollaborator
- Research Unit, Psyciatric Centre Bispebjergcollaborator
- Research Institute of Biological Psychiatry,Psychiatric Centre Sct. Hanscollaborator
- Danish Centre for Health Technology Assessmentcollaborator
- The Ministry of Health and Prevention, Denmarkcollaborator
- TrygFonden, Denmarkcollaborator
Study Sites (1)
Department of Clinical Pharmacology, Bispebjerg Hospital and Research Unit, Psychiatric Centre Bispebjerg
Copenhagen, 2400, Denmark
Related Publications (1)
Jurgens G, Andersen SE, Rasmussen HB, Werge T, Jensen HD, Kaas-Hansen BS, Nordentoft M. Effect of Routine Cytochrome P450 2D6 and 2C19 Genotyping on Antipsychotic Drug Persistence in Patients With Schizophrenia: A Randomized Clinical Trial. JAMA Netw Open. 2020 Dec 1;3(12):e2027909. doi: 10.1001/jamanetworkopen.2020.27909.
PMID: 33284338DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gesche Jürgens, MD, phd
Department of Clinical Pharmacology, Bispebjerg University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
June 26, 2008
First Posted
June 30, 2008
Study Start
February 1, 2008
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
February 10, 2012
Record last verified: 2012-02