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

NCT03114098 | Completed

• 1 other identifier: 16-HPNCL-02
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Drug Resistance; Psychotropic Drugs

Keywords

Drug Resistance; CYP2D6; cytochrom P450

Outcome Measures

Primary Outcomes (1)

• prevalence of a CYP2D6 duplication or polymorphisms

  study the prevalence of a CYP2D6 duplication or polymorphisms associated with an ultrafast metabolizing phenotype in a population of children and adolescents who are drug-resistant to antipsychotic and antidepressant psychotropic drugs. performed by analysis of salivar sample

  At baseline

Secondary Outcomes (7)

• Psychiatric diagnosis and comorbidities

  At baseline

• Global Severity of illness

  At baseline

• Severity of illness for children

  At baseline

• Current and previous psychotropic treatment

  At baseline

• Side effects in different psychotropic treatments

  At baseline

Study Arms (1)

CYP2D6 gene abnormalities

EXPERIMENTAL

* A salivary sample (2 ml sample) which will allow the investigation of an anomaly of the metabolism of psychotropic drug. * Blood sampling will be performed to assess treatment tolerance (6 ml). A sample (4 ml) will be kept for possible future analyzes in relation to the objectives of this study for the recruiting center of Nice. * Electrocardiogram * Clinical exam * Clinical Global Impression Scale (CGI-S) * Children's Global Assessment Scale (CGAS) * Sheehan Disability Scale (SDS) * Wechsler Preschool and Primary Scale of Intelligence III (WPPSI-III ) * Wechsler Intelligence Scale for Children - 4 (WISC-4) * Wechsler Adult Intelligence Scale 4 (WAIS 4) * Diagnostic and Statistical Manual of Mental Disorders (DSM) * Autism Diagnostic Interview (ADI)

Other: gene abnormalities

Interventions

gene abnormalities OTHER

A salivary sample (2 ml sample) Blood sampling will be performed to assess treatment tolerance (6 ml)

CYP2D6 gene abnormalities

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pharmaco resistance to psychotropic drugs
• Obtaining the informed consent of the patient and his / her parents or legal guardian
• Affiliation to a social security system

You may not qualify if:

• Patient deprived of liberty

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (1)

Fondation Lenval Hôpitaux Pédiatriques de Nice CHU-LENVAL

Nice, 06200, France

Location

Study Officials

• Susanne THÜMMLER, MD

  Fondation Lenval Hôpitaux Pédiatriques de Nice CHU-LENVAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: April 14, 2017
• Study Start: December 7, 2016
• Primary Completion: December 12, 2018
• Study Completion: January 31, 2019
• Last Updated: February 26, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)