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Cost-effectiveness of CYP2D6 and CYP2C19 Genotyping in Psychiatric Patients in Curacao

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02713672
Recruitment Status : Completed
First Posted : March 21, 2016
Last Update Posted : March 21, 2016
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Parnassia
Klinika Capriles
Psychiaters Maatschap Antillen
Information provided by (Responsible Party):
GGZ Centraal

Brief Summary:

The cytochrome P450 (CYP) is a group of metabolic enzymes, from which the 2D6 and CYP2C19 polymorphisms are specifically related to the metabolism of psychiatric drugs. The prevalence of CYP2D6 and CYP2C19 polymorphisms differs among ethnicities. Depending on the number of functional alleles, individuals are classified as Poor Metabolizer (PM), Intermediate Metabolizer (IM), Extensive Metabolizer (EM) or Ultra Rapid Metabolizer (UM).

Research has suggested that PM genotype is a predisposing factor for antipsychotic-induced side-effects. Besides susceptibility for side effects and lower quality of life, also, a relationship between phenotype and costs of care has been shown.

Guidelines recommend that PM, IM and UM genotypes need dose adjustment, to optimize the effectiveness of the drug and/or to reduce side effects. No research has been done to investigate cost-effectiveness of implementation of genotyping in daily clinical psychiatric practice.

This study investigates the effectiveness of implementation of CYP2D6 and CYP2C19 genotyping in psychiatric patients in Curacao and analyzes the costs of genotyping versus health benefits.


Condition or disease Intervention/treatment Phase
CYP2D6, Psychiatric Patients Other: Dose adjustment according to genotype Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cost-effectiveness of CYP2D6 and CYP2C19 Genotyping in Psychiatric Patients in Curacao
Study Start Date : October 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Experimental: Intervention group
Psychiatric patients with a CYP2D6 or CYP2C19 PM or IM genotype, using antidepressants or antipsychotics metabolized by CYP2D6 or CYP2C19
Other: Dose adjustment according to genotype
Patients in the intervention group received a dose adjustment according to their CYP2D6 or CYP2C19 genotype based on guidelines of the KNMP

No Intervention: Control group
Psychiatric patients with a CYP2D6 or CYP2C19 EM genotype using antidepressants or antipsychotics



Primary Outcome Measures :
  1. St Hans Rating Scale [ Time Frame: 4 months ]
    Improvement on movement disorders

  2. BPRS [ Time Frame: 4 months ]
    Improvement on psychiatric symptoms

  3. WHODAS 2.0 [ Time Frame: 4 months ]
    Improvement on global functioning


Secondary Outcome Measures :
  1. BMI [ Time Frame: 4 months ]
    improvement in metabolic parameters

  2. EQ 5D [ Time Frame: 4 months ]
    Improvement in quality of life

  3. SWN-20 [ Time Frame: 4 months ]
    Improvement in subjective well-being under neuroleptics

  4. blood pressure [ Time Frame: 4 months ]
    Lowering of blood pressure

  5. cholesterol spectrum [ Time Frame: 4 months ]
    lowering of serum cholesterol



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Antillean ethnicity, defined in line with the Dutch Central Bureau of Statistics as birth on the former Dutch Antilles and birth of at least one parent on the former Dutch Antilles
  2. age 18 years or older
  3. use of an antipsychotic or antidepressant drug
  4. written informed consent.

Exclusion Criteria:

1) no informed consent


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02713672


Locations
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Netherlands
Zon en Schild
Amersfoort, Utrecht, Netherlands, 3818EW
Sponsors and Collaborators
GGZ Centraal
ZonMw: The Netherlands Organisation for Health Research and Development
Parnassia
Klinika Capriles
Psychiaters Maatschap Antillen
Investigators
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Study Chair: Peter van Harten, Professor GGZ Centraal
Study Chair: Wijbrand Hoek, Professor Parnassia
Study Chair: David Vinkers, PhD Maastricht University
Principal Investigator: Anne Koopmans, MD Maastricht University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GGZ Centraal
ClinicalTrials.gov Identifier: NCT02713672    
Other Study ID Numbers: 70-72600-98-005
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: March 21, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data about the individual CYP profiles is handed to involved clinicians after the research has finished