NCT05839613Toborzás még nem indult
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2023. máj. 3. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 400 (tervezett)
- Első benyújtás
- 2023. ápr. 20.
- Kezdés
- 2023. máj.
- Elsődleges befejezés
- 2027. máj.
- Fő szponzor
- Assistance Publique Hopitaux De Marseille
- Betegségek
- Skizofrénia
- NCT-szám
- NCT05839613
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 400
- 2023. máj. és az elsődleges befejezés (2027. máj.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Korábbi kezelés
- Previous PG testing used for drug therapy adjustment.
Egyéb
- 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.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – 60 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.