Clinical Trials Logo

Clinical Trial 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, with genotypes associated with deviant CYP450 metabolizer status are randomized over two strategies: dosing based both on CYP450-genotype and blood level measurements and dosing as usual (standard doses plus blood levels). A third arm of 100 patients with normal CYP450-activity serves as a reference group (standard dosing and blood levels). We hypothesize that for patients with genotypes reflecting deviant CYP450 enzyme activity, 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03548675
Study type Interventional
Source Radboud University
Contact Joost Janzing, MD PhD
Phone +31-(0)243613489
Email Joost.Janzing@radboudumc.nl
Status Not yet recruiting
Phase Phase 4
Start date June 2018
Completion date May 2021

See also
  Status Clinical Trial Phase
Completed NCT02919501 - Study of the Efficacy and Safety of Initial Administration of 17 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder Phase 2
Completed NCT00976560 - Clinical Study to Test a New Drug to Treat Major Depression Phase 2
Recruiting NCT03283670 - Inhaled Nitrous Oxide for Treatment-Resistant Depression: Optimizing Dosing Strategies Phase 2
Suspended NCT02546024 - Predictors of Treatment Response in Late-onset Major Depressive Disorder N/A
Completed NCT02452892 - Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD) N/A
Completed NCT01407575 - Buprenorphine for Treatment Resistant Depression Phase 3
Completed NCT01583400 - Enhanced Collaborative Depression Treatment in Primary Care: The RESPECT-D-E Trial N/A
Completed NCT01152996 - Safety and Tolerability of Vortioxetine (LuAA21004) - Open Label Extension Study Phase 3
Enrolling by invitation NCT00762866 - Psychiatric Genotype/Phenotype Project Repository N/A
Completed NCT00384033 - Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder Phase 3
Completed NCT00369343 - Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women Phase 3
Completed NCT00366652 - Study Evaluating the Effects of DVS SR and Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects Phase 3
Completed NCT00149643 - Effectiveness of Fluoxetine in Young People for the Treatment of Major Depression and Marijuana Dependence Phase 2
Completed NCT00316160 - Sexual Functioning Study With Antidepressants Phase 4
Terminated NCT00569062 - A Study of GW856553X For the Treatment of Depression Phase 2
Completed NCT03001440 - A 7-year Assessment on Subject Understanding of ZYBAN/ WELLBUTRIN Associated Risks N/A
Recruiting NCT03185819 - Study to Evaluate the Efficacy and Safety of 3 Fixed Doses of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Participants Assessed to be at Imminent Risk for Suicide Phase 2
Recruiting NCT03288675 - Stepped Care aiTBS 2 Depression Study (Ghent) N/A
Recruiting NCT03014544 - Study to Evaluate the Performance Validity and Test-Retest Reliability of a Computer-Administered Cognitive Test Battery in Participants With Major Depressive Disorder (MDD)
Not yet recruiting NCT03051256 - Safety, Tolerability, PK, and Symptom Response of REL-1017 (d-Methadone) in Major Depressive Disorder Phase 2