Pharmacogenetics Informed Tricyclic Antidepressant Dosing (PITA) (PITA)
Depressive Disorder, Major
About this trial
This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Pharmacogenetics, Antidepressive Agents
Eligibility Criteria
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 18-65 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.
Sites / Locations
- Radboudumc Dept of Psychiatry
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Genotype-guided TCA treatment
Standard TCA treatment
Genotype guided dosing of the TCAs in patients with a PM,IM,EM or UM phenotype based on pharmacogenetic test.
Standard dosing of TCA in patients with a PM,IM, EM or UM phenotype based on pharmacogenetic test