Dimensional and Developmental Profiles of Psychosis in Children and Adolescents (NCT04370730) | Clinical Trial Compass
RecruitingNot Applicable
Dimensional and Developmental Profiles of Psychosis in Children and Adolescents
France200 participantsStarted 2021-06-02
Plain-language summary
Five collaborating sites in France will study the broad spectrum of schizophrenia in children and adolescents. Patients will be studied with diagnostic interviews, developmental histories, dimensional clinical ratings, comprehensive cognitive assessments, neuroimaging and DNA (copy number variant) analyses (in families and patients who agree), and follow-up of course of illness, cognitive status and treatment response to specific antipsychotic drugs. The goal of the study is to test a prior hypothesis about clinical subgroups in this population and to test whether these subgroups predict antipsychotic medication response.
Who can participate
Age range
7 Years – 20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Children and young adults ages 7-20 years with age of onset of psychotic disorder between 7-17 years.
. Hospitalized or seen for out-patient treatment for a psychotic episode, acute or chronic.
. DSM-V diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder not otherwise specified, or major depressive episode with psychotic features.
. 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.
. Written informed consent signed by the patient if he/she is a major, after clinical stabilization (not delusional).
. Has health insurance coverage from Social Security (France) (not AME coverage).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Lifetime Dimensions of Psychosis Scale-Child and Adolescent Version
. Siblings : siblings are eligible to participate if there are at least two first-degree relatives with psychotic disorders (including the patient) in the family.
Exclusion criteria
. Moderate or severe intellectual deficiency (IQ \< 50).
. Psychoses judged to be secondary to medical illness, medication effects or drugs of abuse.
. Diagnosis of bipolar disorder.
. Patients who are under legal guardianship.
. For the neuroimaging part of the study only : any contraindications to Magnetic Resonance Imaging.