Clinical and neuropsychological factors associated with second generation antipsychotic response in patients diagnosed with first episode of early onset schizophrenia spectrum disorders

FUNDACIÓN SANT JOAN DE DE0 sites0 target enrollmentNovember 17, 2009

Overview

No summary available.

Registry

who.int

Start Date

November 17, 2009

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

FUNDACIÓN SANT JOAN DE DE

•1\. Patients of both sexes, aged 8 to 19 years, both inclusive.
•2\. Score of at least moderate severity on one of the positive psychotic symptom ratings of the PANSS or BPRS\-C.
•3\. Meet DSM\-IV criteria for first episode of schizophrenia, schizophreniform, schizoaffective disorder.
•4\. Patients with reproductive potential will use an effective birth control method during the entire duration of the trial. Women of reproductive age will be included after a negative pregnancy test result.
•5\. Informed consent of parents or legal guardian and informed assent of a mature minor.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 70
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 30
•F.1\.3 Elderly (\>\=65 years) no

•1\. History of appropriate treatment with paliperidone, aripiprazole or haloperidol (defined as at least 8 weeks of treatment with doses of paliperidone 12 mg/d, aripiprazole 30 mg/d, haloperidol 8 mg/d during the final 2 weeks of treatment) during current psychotic episode.
•2\. History of appropriate antipsychotic treatment (8\-16 weeks) with the study drugs during a previous episode.
•3\. Hypersensitivity to paliperidone, aripiprazole or haloperidol or presence of any contraindications to start any of these treatments depending on technical data sheet.
•4\. Bipolar disorder, primary posttraumatic stress disorder, primary personality disorder, diagnosed by a doctor and confirmed by KID\-SCID
•5\. Current major depressive disorder that is clearly defined and therefore excludes diagnosis of EOSS.
•6\. Premorbid diagnosis of mental retardation
•7\. Endocrinological or neurological conditions that confound the diagnosis or are a contraindication to treatment (concurrent organic disease that is clearly defined and therefore excludes diagnosis of EOSS).
•8\. Pregnant or breastfeeding