Effect of Genotyping for CYP450 Polymorphisms Versus Intense Clinical Monitoring on Antipsychotic Drug Treatment
February 9, 2012 updated by: Gesche Jurgens
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
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
311
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen, Denmark, 2400
- Department of Clinical Pharmacology, Bispebjerg Hospital and Research Unit, Psychiatric Centre Bispebjerg
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosed with schizophrenia
- Able to give written informed consent
Exclusion Criteria:
- Genotyped prior to inclusion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: 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.
|
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.
|
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.
|
In this studyarm (3), (Control) treatment followed usual local practice.
The genotype information was not revealed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time to discontinuation of initial antipsychotic treatment
Time Frame: one year
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one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Compliance
Time Frame: one year
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one year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Gesche Jürgens, MD, phd, Department of Clinical Pharmacology, Bispebjerg University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
June 26, 2008
First Submitted That Met QC Criteria
June 27, 2008
First Posted (Estimate)
June 30, 2008
Study Record Updates
Last Update Posted (Estimate)
February 10, 2012
Last Update Submitted That Met QC Criteria
February 9, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-D-2007-0056
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.