An open label signal detection study to evaluate the effects of cariprazine on cognitive functioning in patients with schizophrenia in need of adjustment of oral antipsychotic treatment

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medizinische Universitaet Innsbruck

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

21 Mar 2021 → ongoing

Decision date (initial)

2024-10-29

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Gedeon Richter Plc.

External identifiers

EU CT number

2024-518042-24-00

EudraCT number

2020-005726-29

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The primary objective is to assess changes in cognitive functioning in schizophrenia patients starting treatment with cariprazine

Secondary objectives 2

1. Secondary objectives include the longitudinal assessment of BACS and HFERST scores, symptom severity, personal and social performance, quality of life, as well as extrapyramidal motor symptoms
2. The short- and medium-term effects of cariprazine on working memory/social cognition and on structural and functional cerebral connectivity will be assessed by using functional magnetic resonance imaging (fMRI)

Conditions and MedDRA coding

schizophrenia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Diagnosis of schizophrenia as defined by ICD-10 as determined by the M.I.N.I.
2. Age 18-65 years
3. Without hospitalization due to worsening of psychosis 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

Exclusion criteria 14

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 (PANSS FSNS >24 and PANSS FSPS <19) to avoid pseudospecificity
3. Presence of clinically significant extrapyramidal symptoms, defined a score of ≥ 3 on one of the subscales of the St. Hans Rating Scale (global hyperkinesia subscale, global parkinsonism subscale, dystonia subscale, akathisia subscale) 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)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. To investigate changes in the BACS and HFERST scores and in fMRI data from baseline to week 28

Secondary endpoints 1

1. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medizinische Universitaet Innsbruck

Sponsor organisation

Medizinische Universitaet Innsbruck

Address

Innrain 52

City

Innsbruck

Postcode

6020

Country

Austria

Scientific contact point

Organisation

Medizinische Universitaet Innsbruck

Contact name

University Hospital for Psychiatry I

Public contact point

Organisation

Medizinische Universitaet Innsbruck

Contact name

University Hospital for Psychiatry I

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications