Effects and Cost-Effectiveness of Pharmacogenetic Screening among Elderly Starters with Antidepressants: A Pragmatic Randomized Controlled Trial

Effects and Cost-Effectiveness of Pharmacogenetic Screening among Elderly Starters with Antidepressants: A Pragmatic Randomized Controlled Trial - Cytochrome P450-2D6 screening in elderly using antidepressants

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40010

Enrollment

750

Registered

2012-07-10

Start date

2013-02-12

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

depression

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: *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

Exclusion criteria

Exclusion criteria: *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

Design outcomes

Primary

Measure	Time frame
Main study parameter/endpoint Time to reach adequate serum drug levels according to the guidelines (nortriptyline 50- 150 µg/L; venlafaxine + desmethylvenlafaxine: 250- 750 µg/L).	—

Secondary

Measure	Time frame
Secondary study parameters/endpoints o Adverse events by using an abbreviated self-reported Antidepressant Side Effect Checklist (ASEC), self-reported functional health status and general and disease-specific quality of life by means of EQ5D (including VAS). o Incremental cost-effectiveness ratio for intervention versus control strategy from a societal perspective including uncertainty analysis (bootstrapping, Fieller*s estimates), discounting, scenario analysis, (probabilistic) sensitivity analysis and presentation in cost-effectiveness acceptability curves. Other study parameters At each visit to the physician, data on health care associated resource use will be collected (e.g. visits to the specific specialists including diagnoses; drug use including exact dosing and durations of prescriptions; hospitalizations, inclusive exact intensities of care; and lab values if relevant) and effects on productivity will be investigated. To control for the influence of severity of depression on primary and secondary parameters, severity of depression will be measured by means of the QIDS-SR	—

Measure

Time frame

Secondary study parameters/endpoints o Adverse events by using an abbreviated self-reported Antidepressant Side Effect Checklist (ASEC), self-reported functional health status and general and disease-specific quality of life by means of EQ5D (including VAS). o Incremental cost-effectiveness ratio for intervention versus control strategy from a societal perspective including uncertainty analysis (bootstrapping, Fieller*s estimates), discounting, scenario analysis, (probabilistic) sensitivity analysis and presentation in cost-effectiveness acceptability curves. Other study parameters At each visit to the physician, data on health care associated resource use will be collected (e.g. visits to the specific specialists including diagnoses; drug use including exact dosing and durations of prescriptions; hospitalizations, inclusive exact intensities of care; and lab values if relevant) and effects on productivity will be investigated. To control for the influence of severity of depression on primary and secondary parameters, severity of depression will be measured by means of the QIDS-SR

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Countries

Netherlands

Outcome results