Cytochrome P450-2D6 Screening Among Elderly Using Antidepressants (CYSCE) (CYSCE)
Depression, Depressive Disorder, Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant
About this trial
This is an interventional screening trial for Depression focused on measuring Pharmacogenetics, Depression, Depressive Disorder, Cytochrome P-450 CYP2D6, Antidepressive Agents, Tricyclic, Antidepressive Agents, Second-Generation, Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant, Intermediate Metabolizer Due to Cytochrome P450 CYP2D6 Variant, Ultrarapid Metabolizer Due to Cytochrome P450 CYP2D6 Variant, Multicenter studies
Eligibility Criteria
Inclusion Criteria:
- Major depression according to DSM-IV (296.2x, 296.3x) criteria for which the treating psychiatrist decided to start drug treatment with either nortriptyline or venlafaxine.
- Competent to understand the informed consent procedure
Exclusion Criteria:
- Use of clinically relevant CYP2D6 inhibitors
- Use of clinically relevant CYP2D6 inducers
- Use of other drugs that affect plasma levels as co-medication
- Serious hepatic failure
- Patients for which drug treatment with venlafaxine is started and a GFR < 30 ml/min.
- Patients with the very rare genotype: Intermediate Metabolizer with duplications (IMDUP).
Sites / Locations
- GGZ WNB
- Jeroen Bosch Ziekenhuis
- Reinier van Arkel groep
- GGz inGeest
- Parnassia
- GGZ Centraal
- Lentis
- University Medical Centre Groningen
- GGZ-NHN
- GGZ Friesland
- Isala Klinieken
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
No Intervention
Experimental
Normal genotype- control (NG-C)
Deviating genotype -control (DG-C)
Deviating genotype (DG-I)
In the external control group, an advice for dose adaptation based on patients serum drug levels will be given to the physician according to current daily practice. Allocation to this arm is not based on randomization.
In the internal control group, an advice for dose adaptation based on patients serum drug levels will be given to the physician according to current daily practice
In the intervention group, genotype information accompanied by a drug dosing advice will be given to the treating physician. Blood level of the drug will be communicated by a dedicated research team to the treating physician according to daily practice.