NCT02713672

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 21, 2016

Completed
Last Updated

March 21, 2016

Status Verified

March 1, 2016

Enrollment Period

8 months

First QC Date

February 23, 2016

Last Update Submit

March 15, 2016

Conditions

CYP2D6, Psychiatric Patients

Outcome Measures

Primary Outcomes (3)

  • St Hans Rating Scale

    Improvement on movement disorders

    4 months

  • BPRS

    Improvement on psychiatric symptoms

    4 months

  • WHODAS 2.0

    Improvement on global functioning

    4 months

Secondary Outcomes (5)

  • BMI

    4 months

  • EQ 5D

    4 months

  • SWN-20

    4 months

  • blood pressure

    4 months

  • cholesterol spectrum

    4 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Psychiatric patients with a CYP2D6 or CYP2C19 EM genotype using antidepressants or antipsychotics

Interventions

Dose adjustment according to genotypeOTHER

Patients in the intervention group received a dose adjustment according to their CYP2D6 or CYP2C19 genotype based on guidelines of the KNMP

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • age 18 years or older
  • use of an antipsychotic or antidepressant drug
  • written informed consent.

You may not qualify if:

  • \) no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zon en Schild

Amersfoort, Utrecht, 3818EW, Netherlands

Location

Related Publications (2)

  • Koopmans AB, van Hoeken D, Clarke DE, Vinkers DJ, van Harten PN, Hoek HW. Proxy WHO Disability Assessment Schedule 2.0 Is Clinically Useful for Assessing Psychosocial Functioning in Severe Mental Illness. Front Psychiatry. 2020 Apr 15;11:303. doi: 10.3389/fpsyt.2020.00303. eCollection 2020.

    PMID: 32351419DERIVED

  • Koopmans AB, Vinkers DJ, Poulina IT, Gelan PJA, van Schaik RHN, Hoek HW, van Harten PN. No Effect of Dose Adjustment to the CYP2D6 Genotype in Patients With Severe Mental Illness. Front Psychiatry. 2018 Aug 7;9:349. doi: 10.3389/fpsyt.2018.00349. eCollection 2018.

    PMID: 30131727DERIVED

Study Officials

  • Peter van Harten, Professor

    GGZ Centraal

    STUDY CHAIR

  • Wijbrand Hoek, Professor

    Parnassia

    STUDY CHAIR

  • David Vinkers, PhD

    Maastricht University

    STUDY CHAIR

  • Anne Koopmans, MD

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2016

First Posted

March 21, 2016

Study Start

October 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

March 21, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will share

Data about the individual CYP profiles is handed to involved clinicians after the research has finished

Locations

NL(1)