NCT05839613Not yet recruiting
PhaRmacOgenetics and Therapeutic Drug Monitoring In SchizophrEnia
How Personalized Medicine Based on Pharmacogenetics and Therapeutic Drug Monitoring Can Reduce Relapse Rate in Patients WITH schizophreniA: An Analytical, Experimental, Prospective, Comparative, Adaptive Randomized, Open-label, Multicenter Clinical Trial
Source: ClinicalTrials.gov · Last updated 3 May 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Schizophrenia is a severe chronic mental disorder with a long-term treatment. Most antipsychotic (AP) drugs are effective for only 30% to 60% of patients and for many drugs, treatment selection remains a "trial-and-error" process.The main result of treatment inefficiency is relapse, the recurrence of acute symptoms after a period of partial or complete remission. Pharmacogenetics (PG) is the study of genetic differences in drug met-abolic pathways which can affect individual responses to drugs, both in terms of therapeutic effect as well as adverse effects. PG testing could therefore identify patients at potentially high risk of relapse allowing the opportunity of an individualized prescription. In this study, PG was shown to improve the safety profile of AP treatments in patients presenting PM or UM CYP variants, by reducing associated side effects. Therapeutic Drug Monitoring (TDM) is the quantification and interpretation of drug concentration in blood to optimize pharmacotherapy . For drugs with established therapeutic reference ranges (TRR) or with a narrow therapeutic index, it makes sense to measure drug concentrations in blood for dose titration after initial prescription or after dose change. Non adherence is a recurrent problem in the management of schizophrenia, leading to reduced quality of life and increased risk of relapse. TDM is recognized as a direct reliable measure for drug adherence and can be an additional support after a therapy adjustment. Additionally, TDM can be useful to educate patients and make them more aware of their treatment. Finally, TDM is likely to ensure a better tolerance and fewer side effects for APs, while allowing a better efficacy. However, evidence on the clinical impact of this tool in schizophrenic population is lacking and randomized clinical trials are needed to confirm it. Finally, relapses occur frequently in schizophrenia and the cost for a relapsing schizophrenic patient is estimate over 4 times higher than for a non-relapsing patient, highlighting the importance of cost-effective care strategies. When separately used PG testing or TDM alone, might not be sufficient to ensure the clinical utility and cost-effectiveness of these tests. We hypothesize that individualized medicine including the association of PG testing with TDM (PG/TDM intervention), on the most commonly prescribed AP drugs, can reduce relapse rate at one year while being cost-effective.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 20 Apr 2023
- Start date
- May 2023
- Primary completion date
- May 2027
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Diseases
- Schizophrenia
- NCT number
- NCT05839613
What you commit to
- Study type: Interventional
- Planned participants: 400
- From May 2023 to the primary completion date, May 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous PG testing used for drug therapy adjustment.
Other
- Patients who do not meet the schizophrenia criteria as defined in the DSM-5.
- Patient with current prescription of clozapine.
- Patient who are in maintenance phase and optimally treated e.g. satisfactory treat- ment regarding symptoms or AEs (Gaebel et al. 2010).
- Pregnant or breastfeeding woman.
- Subject refusing to give written informed consent.
- Adults protected by the law
- Subject non-affiliated to the French health insurance.
Who the study is looking for
- Age ≥18 years and ≤ 60 years.
- Diagnostic of schizophrenia according to DSM-5.
- The clinical situation of the patient justifies a modification of his AP treatment according to the judgment of the attending psychiatrist (relapsing patients or patients in maintenance phase judged clinically stable by the attending psychiatrist but not optimally treated e.g. non- satisfactory treatment regarding symptoms or adverse events (AEs), Gaebel et al. 2010) or non-compliant patient or patient who has stopped the AP treatment.
- The patient is to receive a prescription for at least one of the following molecules in oral or injectable forms: aripiprazole, olanzapine, paliperidone, quetiapine, risperidone, amisulpride
- Women and men of reproductive potential must agree to use highly effective contraception during the study.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.