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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
(1) Genotyping for CYP4502D6 and 2C19 polymorphisms
(2) Intense clinical monitoring
(3) Control
Sponsored by
Gesche Jurgens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Schizophrenia focused on measuring Pharmacogenetics, Compliance, Antipsychotic drugs, Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with schizophrenia
  • Able to give written informed consent

Exclusion Criteria:

  • Genotyped prior to inclusion

Sites / Locations

  • Department of Clinical Pharmacology, Bispebjerg Hospital and Research Unit, Psychiatric Centre Bispebjerg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

No Intervention

Arm Label

Genotyping for CYP4502D6 and 2C19 polymorphisms

(2) Intense clinical monitoring

(3) Control

Arm Description

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 (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.

Outcomes

Primary Outcome Measures

Time to discontinuation of initial antipsychotic treatment

Secondary Outcome Measures

Compliance

Full Information

First Posted
June 26, 2008
Last Updated
February 9, 2012
Sponsor
Gesche Jurgens
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
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1. Study Identification

Unique Protocol Identification Number
NCT00707382
Brief Title
Effect of Genotyping for CYP450 Polymorphisms Versus Intense Clinical Monitoring on Antipsychotic Drug Treatment
Official Title
A Three-armed Randomised Controled Trial on the Effect of Genotyping for CYP450 Polymorphisms and Intense Clinical Monitoring on Antipsychotic Drug Treatment.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gesche Jurgens
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Pharmacogenetics, Compliance, Antipsychotic drugs, Schizophrenia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
311 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Genotyping for CYP4502D6 and 2C19 polymorphisms
Arm Type
Other
Arm Description
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.
Arm Title
(2) Intense clinical monitoring
Arm Type
Other
Arm Description
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.
Arm Title
(3) Control
Arm Type
No Intervention
Arm Description
In this studyarm (3), (Control) treatment followed usual local practice. The genotype information was not revealed.
Intervention Type
Genetic
Intervention Name(s)
(1) Genotyping for CYP4502D6 and 2C19 polymorphisms
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
(2) Intense clinical monitoring
Intervention Description
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 Type
Other
Intervention Name(s)
(3) Control
Intervention Description
In this studyarm (3), (Control) treatment followed usual local practice. The genotype information was not revealed.
Primary Outcome Measure Information:
Title
Time to discontinuation of initial antipsychotic treatment
Time Frame
one year
Secondary Outcome Measure Information:
Title
Compliance
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with schizophrenia Able to give written informed consent Exclusion Criteria: Genotyped prior to inclusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gesche Jürgens, MD, phd
Organizational Affiliation
Department of Clinical Pharmacology, Bispebjerg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Pharmacology, Bispebjerg Hospital and Research Unit, Psychiatric Centre Bispebjerg
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
33284338
Citation
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.
Results Reference
derived

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

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