Effects and Cost-Effectiveness of Pharmacogenetic Screening among Elderly Starters with Antidepressants: A Pragmatic Randomized Controlled Trial
- Conditions
- depression10027946
- Registration Number
- NL-OMON40010
- Lead Sponsor
- Rijksuniversiteit Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 750
*Age 60 years or older
*Major depression according to DSM-IV criteria for which the treating psychiatrist decided to start drug treatment with either nortriptyline or venlafaxine
*Competent to understand the informed consent procedure
*Use of clinically relevant CYP2D6 inhibitors (e.g. fluoxetine, paroxetine, quinidine, ritonavir, efavirenz)
*Use of clinically relevant CYP2D6 inducers (e.g. dexamethasone, rifampicine)
*Use of other drugs that affect plasma levels as co-medication
*Serious hepatic failure (ASAT/ALAT or gamma-GT * twice the maximal reference value)
*Patients for which drug treatment with venlafaxine is started and a GFR < 30 ml/min.
*Patienst with the very rare genotype: Intermediate Metabolizer with duplications (IMDUP).
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameter/endpoint<br /><br>Time to reach adequate serum drug levels according to the guidelines<br /><br>(nortriptyline<br /><br>50- 150 µg/L; venlafaxine + desmethylvenlafaxine: 250- 750 µg/L).</p><br>
- Secondary Outcome Measures
Name Time Method