Schizophrenia
Conditions
Interventions
Trade Name: Reagila
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Cariprazine
CAS Number: 1083076-69-0
Other descriptive name: CARIPRAZINE HYDROCHLORIDE
Concentration unit: mg milligram(s)
C
Sponsors
Medical University Innsbruck
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of schizophrenia as defined by ICD-10 as determined by the M.I.N.I. 2. Age 18-65 years 3. Clinically stable without hospitalization and without any modification in psychopharmacological treatment for at least 8 weeks 4. In need of adjustment of the current oral antipsychotic treatment as judged by the treating psychiatrist 5. CGI-S baseline score = 4 6. Capable of providing written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. A score of = 5 on the PANSS items related to delusions (P1), conceptual disorganization (P2), and hallucinatory behavior (P3) 2. Presence of predominant negative symptoms (moderate to severe negative symptoms of greater relative severity than co-occurring positive symptoms, i.e., PANSS scores greater for negative than positive symptoms) to avoid pseudospecificity 3. Presence of clinically significant extrapyramidal symptoms, defined as a total score of = 3 on the St. Hans Rating Scale and/or the use of anticholinergics for the treatment of extrapyramidal motor symptoms 4. Presence of clinically significant symptoms of depression, defined as a total score of = 11 on the CDSS 5. Active suicidal ideation as measured through the C-SSRS, defined as an answer of ‘Yes’ to items 4 and/or 5 6. A diagnosis of alcohol and/or drug abuse or dependence as assessed through the M.I.N.I. or a positive UDS 7. IQ of 70 or less as assessed through the MWT-B 8. Patients who are currently treated with cariprazine or have shown insufficient response or intolerance to cariprazine in the past 9. Current treatment with clozapine 10. Patients who participated in another trial with an investigational drug or cognitive-enhancing intervention within 90 days prior to screening 11. Patients who are not fluent in the language of the cognitive batteries and questionnaires 12. Pregnancy or breast-feeding 13. Regularly taking centrally active medications except antipsychotics (mood stabilizers, antidepressants, etc.) 14. Patients with contraindications to MRI (e.g. claustrophobia, pacemaker, non-MRI-compatible implants)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: End of clinical trial;Main Objective: The primary objectives of this study are to investigate changes in the BACS and HFERST scores and in fMRI data from baseline to week 28.;Secondary Objective: Longitudinal changes in the following measures: 1.PANSS 2.NSA-4 3.CGI 4.CDRS 5.SHRS/SMARTS 6.MARS 7.PSP 8.EQ-5D ;Primary end point(s): The primary objectives of this study are to investigate changes in the BACS and HFERST scores and in fMRI data from baseline to week 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Longitudinal changes in the following measures: 1. PANSS 2. NSA-4 3. CGI 4. CDRS 5. SHRS/SMARTS 6. MARS 7. PSP 8. EQ-5D;Timepoint(s) of evaluation of this end point: End of clinical trial | — |
Countries
Austria
Contacts
Public ContactKompetenzzentrum Klinische Studien
Medical University
Outcome results
None listed