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| Name | Class |
|---|---|
| Bispebjerg Hospital | OTHER |
| Research Unit, Psyciatric Centre Bispebjerg | UNKNOWN |
| Research Institute of Biological Psychiatry,Psychiatric Centre Sct. Hans | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| (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. |
|
| (3) Control | No Intervention | In this studyarm (3), (Control) treatment followed usual local practice. The genotype information was not revealed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (1) Genotyping for CYP4502D6 and 2C19 polymorphisms | Genetic | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to discontinuation of initial antipsychotic treatment | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gesche Jürgens, MD, phd | Department of Clinical Pharmacology, Bispebjerg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Pharmacology, Bispebjerg Hospital and Research Unit, Psychiatric Centre Bispebjerg | Copenhagen | 2400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33284338 | Derived | 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. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
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| ID | Term |
|---|---|
| D005838 | Genotype |
| ID | Term |
|---|---|
| D055614 | Genetic Phenomena |
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| Danish Centre for Health Technology Assessment |
| OTHER |
| The Ministry of Health and Prevention, Denmark | OTHER_GOV |
| TrygFonden, Denmark | INDUSTRY |
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| (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. |
|
| (3) Control | Other | In this studyarm (3), (Control) treatment followed usual local practice. The genotype information was not revealed. |
|
| D015438 | Health Behavior |
| D001519 | Behavior |