EUCTR2012-004546-15-FR
Active, not recruiting
Phase 1
Assessment of incidence of adverse events in a naive pediatric population treated with an antipsychotic drug over 12 months follow-up - Unwanted events in naive pediatric population treated by antipsychotic
Conditionssevere behavioral disorders in mental retardation, autistic syndromesschizophrenia psychosisMedDRA version: 16.0Level: LLTClassification code 10033877Term: Paranoid type schizophreniaSystem Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- severe behavioral disorders in mental retardation, autistic syndromesschizophrenia psychosis
- Sponsor
- CHU de Nice
- Enrollment
- 340
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female patients
- •6 •In whom antipsychotic treatment is indicated
- •Who have never been treated with antipsychotic medication (other than metoclopramide (Primperan®) for pediatric indications).
- •\- Receiving an antipsychotic for less than 15 days
- •\- Without history of exhibition in an antipsychotic or with a history of grip of antipsychotic of less than three consecutive months interrupted for more than six months before the inclusion
- •\- Hospitalized ( e ) in full\-time or day department, or seen ambulatory
- •\- Obtaining of the lit consent, the patient and his parents or the legal person in charge
- •\- Obtaining of the consent lit by the patient become major during the follow\-up
- •\- Membership in a national insurance scheme
- •Are the trial subjects under 18? yes
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified
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