Exploring Psychosis in Children and Adolescents
Dimensional and Developmental Approach to Psychotic Episodes in Children and Adolescents: Impact on Clinical Management
This study is testing how children and teens with psychosis respond to antipsychotic medications over five years to better understand their conditions and treatment outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 7 Years to 20 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 6 sites (Gentilly and 5 other locations) |
| Trial ID | NCT04370730 on ClinicalTrials.gov |
What this trial studies
This study investigates the spectrum of schizophrenia and related psychotic disorders in children and adolescents across five sites in France. It involves comprehensive assessments including diagnostic interviews, cognitive evaluations, neuroimaging, and genetic analyses to understand the clinical subgroups and their responses to antipsychotic medications. Patients with at least one psychotic episode will be included, and their treatment responses will be monitored over a period of up to five years. The goal is to clarify the relationship between developmental profiles and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are children and young adults aged 7-20 with a diagnosed psychotic disorder and a history of psychotic episodes.
Not a fit: Patients without a diagnosis of a psychotic disorder or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for young patients with psychotic disorders.
How similar studies have performed: Other studies have shown promise in understanding psychotic disorders in youth, but this approach combines multiple assessment modalities, making it a novel endeavor.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for the Patient: 1. Children and young adults ages 7-20 years with age of onset of psychotic disorder between 7-17 years. 2. Hospitalized or seen for out-patient treatment for a psychotic episode, acute or chronic. 3. DSM-V diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder not otherwise specified, or major depressive episode with psychotic features. 4. Written informed consent signed by the parents or the individual(s) with legal parental authority, and by the minor patient if his/her condition permits. 5. Written informed consent signed by the patient if he/she is a major, after clinical stabilization (not delusional). 6. Has health insurance coverage from Social Security (France) (not AME coverage). Inclusion Criteria for parents or siblings wishing to participate in the genetic part of the study : 1. Parents : no specific criteria. 2. Siblings : siblings are eligible to participate if there are at least two first-degree relatives with psychotic disorders (including the patient) in the family. 3. Written informed consent for the genetic part of the study signed by any participating parents and siblings. 4. Has health insurance coverage from Social Security (France) (not AME coverage). Exclusion Criteria: 1. Moderate or severe intellectual deficiency (IQ \< 50). 2. Psychoses judged to be secondary to medical illness, medication effects or drugs of abuse. 3. Diagnosis of bipolar disorder. 4. Patients who are under legal guardianship. 5. For the neuroimaging part of the study only : any contraindications to Magnetic Resonance Imaging.
Where this trial is running
Gentilly and 5 other locations
- Fondation Vallée, Gentilly — Gentilly, France (Not_yet_recruiting)
- CHRU de Lille — Lille, France (Not_yet_recruiting)
- CHU de Nice — Nice, France (Not_yet_recruiting)
- Pitié Salpétrière — Paris, France (Recruiting)
- CHU de Rouen — Rouen, France (Not_yet_recruiting)
- CHU de Rouvray — Rouen, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Claudine LAURENT-LEVINSON, M.D., Ph.D.
- Email: claudine.laurent@aphp.fr
- Phone: 1 42 16 23 44
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.