Pharmacogenetics Informed Tricyclic Antidepressant Dosing (PITA)

  • STATUS
    Recruiting
  • days left to enroll
    21
  • participants needed
    200
  • sponsor
    Radboud University
Updated on 26 March 2021
remission
antidepressants
scid
suicidal
major depressive disorder

Summary

Tricyclic Antidepressants (TCA's) are the cornerstone of treatment for patients with severe Major Depressive Disorder (sMDD). Current dosing is guided by repeated measurements of blood levels. Compared to patients with a normal metabolization function, for those with increased CYP450 enzyme activity it takes longer to reach a therapeutic drug level. The consequent delay of drug efficacy is associated with a prolonged treatment period, increased risk of suicidal behaviour and eventually lower remission rates. For those with reduced CYP450 activity higher rates of side effects are expected. An innovative TCA dosing strategy, taking the genetic variants of CYP2D6 and CYP2C19 into account may help to reduce the above mentioned problems. Up till now, the current guidelines for CYP450 pharmacogenetics based TCA dosing have not been systematically evaluated for effectiveness and cost-effectiveness in larger groups of patients. Such evaluation is necessary before broad implementation of these guidelines can be advocated. In the present study 200 patients with sMDD who are treated with nortriptyline, clomipramine or imipramine are randomized over two strategies: dosing based both on CYP450-genotype and blood level measurements and dosing as usual (standard doses plus blood levels). We hypothesize that genotype informed dosing results in faster attainment of therapeutic drug levels, lower rates of side effects, earlier symptom relief and lower levels of health- and working related costs.

Details
Condition Major depression, major depressive disorders
Treatment TCA treatment
Clinical Study IdentifierNCT03548675
SponsorRadboud University
Last Modified on26 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients are in- and outpatients, having a primary diagnosis of severe major
depressive disorder (SCID-I diagnosis in agreement with DSM-5 criteria and a
Hamilton Rating Scale for Depression score 19 (HAM-D-17-item version), aged
-65 years, who, according to their physician, are eligible for treatment
with a TCA (Nortriptyline (NOR), Clomipramine (CLOMI) or Imipramine (IMI))
The choice of the specific TCA is at the discretion of the physician in
attendance

Exclusion Criteria

Psychotic depression
Bipolar I or II disorder
Schizophrenia or other primary psychotic disorder
Drug or alcohol dependence in the past 3 months
Mental Retardation (IQ < 80)
For women: pregnancy or possibility for pregnancy without adequate contraceptive measures
Breastfeeding
Serious medical illness affecting the CNS, including but not restricted to M Parkinson, SLE, brain tumour, CVA
Relevant medical illness as contra-indication for TCA use, such as recent myocardial infarction
Other drugs influencing the pharmacokinetics of the TCAs as based on a list of interacting drugs. In case of psychotropic co-medication only a benzodiazepine in a dose equivalent up to 4 mg lorazepam will be allowed
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