NCT03114098 (M4P) is a NA clinical trial of gene abnormalities in Drug Resistance, sponsored by Fondation Lenval.

Who is sponsoring NCT03114098?

NCT03114098 is sponsored by Fondation Lenval.

What drugs are being tested in NCT03114098?

Interventions in NCT03114098: gene abnormalities.

What condition does NCT03114098 study?

NCT03114098 studies Drug Resistance, Psychotropic Drugs.

Is NCT03114098 still recruiting?

NCT03114098 is currently completed. Last updated 26 February 2019.

Last reviewed 2019-02-26 · How we verify

NCT03114098: M4P

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pharmacogenetics Anomaly Research in Children and Adolescents With Pharmacological Resistance to Psychotropic Drugs

Completed NA Last updated 26 February 2019

What this trial tests

NA trial testing gene abnormalities in Drug Resistance in 22 participants. Completed in 31 January 2019.

Timeline

7 December 2016

Primary endpoint
12 December 2018

31 January 2019

Quick facts

Lead sponsor	Fondation Lenval
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	22
Start date	7 December 2016
Primary completion	12 December 2018
Estimated completion	31 January 2019
Sites	1 location across France

Drugs / interventions tested

gene abnormalities

Conditions studied

Drug Resistance — all drugs for Drug Resistance →
Psychotropic Drugs — all drugs for Psychotropic Drugs →

Sponsor

Fondation Lenval — full company profile →

Who can join

Under 18, any sex, with Drug Resistance or Psychotropic Drugs. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Psychotropic drugs are frequently used in children and adolescents in France with a prescription rate of 2.5%. Antipsychotics (PA) and antidepressants (AD), each concern 0.3% of the pediatric population (Kovess et al., 2015). Despite appropriate pharmacological treatment, some patients are drug-resistant and have persisting symptoms and ineffective psychotropic treatments. These children and adolescents are generally exposed to many psychotropic molecules and often to poly-therapy. Most psychotropic treatments, especially AP and AD, are metabolised at the hepatic level by cytochrome P450 and in particular by CYP2D6. Duplication / multiplication of the CYP2D6 gene induces too rapid metabolism of drugs. Demonstration of a CYP2D6 abnormality has a direct impact on the management of the patient and on the clinical decisions of the clinician. Thus, knowledge of individual metabolism will decrease the failure of treatment, improve quality of life and therapeutic compliance.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Drug Resistance

Currently open trials in the same condition.

NCT07071103 — Intestinal Low Dose Radiotherapy Combined With Immunotherapy in Immune-resistant Metastatic Malignant Solid Tumors · Phase 2 · recruiting
NCT07073755 — Real-World Study of Post-Resistance Treatment Strategies in Advanced Breast Cancer Following CDK4/6i, PIK3CA Inhibitors, · recruiting

Other Fondation Lenval trials

Trials by the same sponsor.

NCT06968546 — Sufentanil Versus Ketamine Intranasally in the Management of Severe Acute Trauma-related Pain in Children. · Phase 2 · not yet recruiting
NCT07383844 — Analysis of Barriers and Facilitators to Adapted Physical Activity for Pediatric Patients With Chronic Inflammatory Bowe · recruiting
NCT07299006 — Evaluation of Paro, a Therapeutic Assistance Robot in Analgesic Management During the Placement of a Peripheral Intraven · NA · not yet recruiting
NCT07068945 — Study of the Transition From Child Psychiatry to Adult Psychiatry in Nice Within a Population of 17-year-old Adolescents · not yet recruiting
NCT06231654 — Evaluation of Remote Photoplethysmography to Assist Vital Signs Measure in Pediatrics · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03114098 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fondation Lenval
Last refreshed: 26 February 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03114098.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing