An open label signal detection pilot study to evaluate the effects of cariprazine on cognitive functioning in patients with schizophrenia in need of adjustment of oral antipsychotic treatment
- Conditions
- SchizophreniaTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2020-005726-29-AT
- Lead Sponsor
- Medical University Innsbruck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 20
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
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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br>1.PANSS<br>2.NSA-4<br>3.CGI<br>4.CDRS<br>5.SHRS/SMARTS<br>6.MARS<br>7.PSP<br>8.EQ-5D<br>;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;Timepoint(s) of evaluation of this end point: End of clinical trial
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Longitudinal changes in the following measures:<br>1. PANSS<br>2. NSA-4<br>3. CGI<br>4. CDRS<br>5. SHRS/SMARTS<br>6. MARS<br>7. PSP<br>8. EQ-5D;Timepoint(s) of evaluation of this end point: End of clinical trial