First episode of early onset schizophrenia spectrum disorders MedDRA version: 14.1 Level: LLT Classification code 10040705 Term: Simple schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: INVEGA® 3 mg COMPRIMIDOS LIBERACIÓN PROLONGADA
Pharmaceutical Form: Tablet
CAS Number: 144598-75-4
Other descriptive name: PALIPERIDONE
Concentration unit: mg milligram(s)
Concentration ty
Sponsors
FUNDACIÓN SANT JOAN DE DEU
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of paliperidone, aripiprazole and haloperidol for episodes of Early Onset Schizophrenia Spectrum (EOSS) disorders, as reflected by treatment response at the end of the acute stage of the trial (first 8 weeks) and all cause treatment discontinuation during the 28 weeks of the study.;Secondary Objective: 1. To compare the therapeutic efficacy of the three antipsychotic agents on other clinically relevant outcomes, including psychotic symptoms and adaptive and neurocognitive functioning. 2. To compare the safety and tolerability of these three agents. 3. To examine the relationship between the steady-state plasma drug levels and clinical response and/or adverse events at weeks 4, 8, and 28.;Primary end point(s): The therapeutic benefits of the three study drugs will be assessed by the Positive and Negative Symptom Scale (PANSS, Kay et al, 1987) and the Clinical Global Impressions-Improvement (CGI-I) scale (NIMH, 1985) at the end of the acute stage (first 8 weeks). Treatment response will be considered as a 20% reduction in the baseline PANSS score plus a CGI-I score of < 2 at the end of the 8-week acute stage (a score of 1 being very much improved and 2 much improved). This definition captures both overall and specific symptom improvement and is similar to the response criteria used by Sikich et al. (2004), which were used as preliminary data for this Project. The responder status of the subjects who withdrew from the study before 8 weeks were determined at the time of withdrawal. Kaplan-Meier survival curves will be used to estimate the rates of all cause treatment discontinuation during the 28 study weeks;Timepoint(s) of evaluation of this end point: End of trial week 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Psychiatric symptoms will be assessed using the PANSS (Kay et al., 1987) and the BPRS-C (Overall and Pfefferbaum, 1982). The CGI scale (Guy, 1976) will assess the severity of illness (CGI-SI) and improvement of the clinical symptoms (CGI-I). 2. To compare the safety and tolerability of the three agents, the following were assessed: - potential adverse events using the Monitoring of Side Effects Scale ? Kalachnik, 2001; - extrapyramidal side effects (EPSEs), using the Simpson Angus Extrapyramidal Symptom Scale (Simpson and Angus, 1970), the Barnes Akathisia Scales (Barnes, 1989) and the Abnormal Involuntary Movement Scale (National Institute of Mental Health, 1985). - weight gain, metabolic parameters (fasting biochemistry, blood count, glucose, free fatty acids, leptin, insulin, haemoglobin A1c, C-peptide, C-reactive protein, total cholesterol, HDL and LDL cholesterol, triglycerides, and prolactin), cardiac functioning (ECG ? corrected QT), hepatic functioning (AST,ALT) and renal functioning (urinary ionogram, microalbumin in urine). 3.To examine the relationship between steady-state drug blood levels and clinical response (CGI-I, PANSS, BPRS-C) and adverse events at weeks 4, 8, and 28.;Timepoint(s) of evaluation of this end point: End of trial week 28 | — |
Countries
Spain
Contacts
Public ContactDña. Rosa María Morales
Fundació Sant Joan de Deu
Outcome results
None listed