SchizophreniaNCT00707382
Effect of Genotyping for CYP450 Polymorphisms Versus Intense Clinical Monitoring on Antipsychotic Drug Treatment
A study testing (1) Genotyping for CYP4502D6 and 2C19 polymorphisms and (2) Intense clinical monitoring in people with Schizophrenia, run by Gesche Jurgens at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- (1) Genotyping for CYP4502D6 and 2C19 polymorphisms and (2) Intense clinical monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2008to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with schizophrenia
- Able to give written informed consent
Who cannot join
- Genotyped prior to inclusion
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Clinical Pharmacology, Bispebjerg Hospital and Research Unit, Psychiatric Centre Bispebjerg
Copenhagen, 2400
About this study
Official title: 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
- Conditions
- Schizophrenia
- Being tested
- (1) Genotyping for CYP4502D6 and 2C19 polymorphisms, (2) Intense clinical monitoring, (3) Control
- Keywords
- Pharmacogenetics, Compliance, Antipsychotic drugs, Schizophrenia
- Medical subject headings
- Schizophrenia, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(1) Genotyping for CYP4502D6 and 2C19 polymorphismsGenetic
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 monitoringOther
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.
(3) ControlOther
In this studyarm (3), (Control) treatment followed usual local practice. The genotype information was not revealed.
| Study group | Role | What they receive |
|---|---|---|
| Genotyping for CYP4502D6 and 2C19 polymorphisms | Other | 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. Receives: Genetic: (1) Genotyping for CYP4502D6 and 2C19 polymorphisms |
| (2) Intense clinical monitoring | Other | 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. Receives: Other: (2) Intense clinical monitoring |
| (3) Control | No intervention | In this studyarm (3), (Control) treatment followed usual local practice. The genotype information was not revealed. Receives: Other: (3) Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to discontinuation of initial antipsychotic treatment
Measured: one year
Secondary outcomes (1)
Compliance
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gesche Jurgens
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor-investigator, Gesche Jurgens, Bispebjerg Hospital
- Investigators
- Gesche Jürgens, MD, phd, Principal investigator, Department of Clinical Pharmacology, Bispebjerg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707382
- Sponsor's protocol ID
- H-D-2007-0056
- Status last verified
- Feb 2012
- First submitted
- 26 Jun 2008
- Last updated
- 10 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33284338
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-armed Randomised Controled Trial on the Effect of Genotyping for CYP450 Polymorphisms and Intense Clinical Monitoring on Antipsychotic Drug Treatment.
- ClinicalTrials.gov ID
- NCT00707382
- Acronym / sponsor ID
- H-D-2007-0056
- Conditions
- Schizophrenia
- Keywords
- Pharmacogenetics, Compliance, Antipsychotic drugs, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Gesche JurgensUniversity, hospital or other
- 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
- Study start
- Feb 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Genotyping for CYP4502D6 and 2C19 polymorphisms | Other | Genetic: (1) Genotyping for CYP4502D6 and 2C19 polymorphismsIn 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 | Other | Other: (2) Intense clinical monitoringIn 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 intervention | Other: (3) ControlIn this studyarm (3), (Control) treatment followed usual local practice. The genotype information was not revealed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with schizophrenia
- Able to give written informed consent
Key exclusion criteria (1 listed)
- Genotyped prior to inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (1) Genotyping for CYP4502D6 and 2C19 polymorphismsIn 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. | Genetic | Genotyping for CYP4502D6 and 2C19 polymorphisms |
| (2) Intense clinical monitoringIn 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 |
| (3) ControlIn this studyarm (3), (Control) treatment followed usual local practice. The genotype information was not revealed. | Other | (3) Control |
Primary outcome
Time to discontinuation of initial antipsychotic treatment
Time frame: one year
1 secondary outcome
Compliance
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2012.
- Derived from this study: PubMed 33284338Jurgens 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gesche Jürgens, MD, phd principal investigator
Department of Clinical Pharmacology, Bispebjerg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing (1) Genotyping for CYP4502D6 and 2C19 polymorphisms and (2) Intense clinical monitoring in people with Schizophrenia, run by Gesche Jurgens at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to discontinuation of initial antipsychotic treatment (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00707382, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2012.