Cognitive effects of adjuntive Vortioxetine in early Schizophrenia

Fundacion Para La Gestion De La Investigacion En Salud De Sevilla1 site in 1 country37 target enrollmentDecember 2, 2024

Drugs3-[2-[4-(6-FLUORO-1,2-BENZOXAZOL-3-YL)PIPERIDIN-1-YL]ETHYL]-2-METHYL-6,7,8,9-TETRAHYDROPYRIDO[2,1-B]PYRIMIDIN-4-ONE PIMOZIDE HALOPERIDOL ZIPRASIDONE AMINAZINE VORTIOXETINE THIORIDAZINE LU21004 HBR RISPERIDONE N-METHYL-3-PHENYL-3-[4-(TRIFLUOROMETHYL)PHENOXY]PROPAN-1-AMINE HYDROCHLORIDE CHLORPROMAZINE ARIPIPRAZOLE OLANZAPINE QUETIAPINE

Overview

Phase: Phase 2/3
Intervention: Not specified
Conditions: Not specified
Sponsor: Fundacion Para La Gestion De La Investigacion En Salud De Sevilla
Enrollment: 37
Locations: 1
Primary Endpoint: Primary outcome measures: Cognitive functioning improvement assessed by the change in BACS App scores.
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Primary objective: To assess the effectiveness of Vortioxetine vs. TAU in the treatment of cognitive impairments in early psychosis, measured by the change From Baseline to Week 24 in Brief Assessment of Cognition in Schizophrenia (BACS App) scores using the Composite Z-score Defined as the Weighted Sum of the Individual Patient Z-scores. [Time Frame: Baseline, week 24, week 26 and week 50]

Registry

euclinicaltrials.eu

Start Date

December 2, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Fundacion Para La Gestion De La Investigacion En Salud De Sevilla

Responsible Party

Principal Investigator

UICEC-HUVR (Clinical Trial Unit)

Scientific

Fundacion Para La Gestion De La Investigacion En Salud De Sevilla

Eligibility Criteria

Inclusion Criteria

•Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (DSM - SCID) diagnosis of Schizophrenia spectrum disorders.
•Age >18-50 years old
•Stable antipsychotic medication doses during at least 4 weeks ( all second generation antipsychotics excluding clozapine).
•No antidepressant treatment for at least 8 weeks prior to randomization.
•PANSS Negative subscore >14 with at least two of the items at a level >/=4 (moderate)
•PANSS Positive subscore </=14 with not more than one of the items at a level >/=4 (moderate)
•Hamilton Depression Rating Scale (HAMD-17) total score </=12
•Simpson Angus Score of any item <2
•Behaviorally Anchored Rating Scale (BARS) of any item </= 1
•Competent and willing to sign informed consent

Exclusion Criteria

•Patients taking any antidepressant and its use cannot be discontinued at least 8 weeks prior to randomization.
•Structural brain disease (based on previous medical records)
•Cognitive disability by history and estimated intelligence quotient (IQ) <70 (ID DSM-5 diagnosis).
•Any serious chronic medical illnesses that may interfere with the patient's ability to comply with the study procedures or that will interfere with cognition.
•Organic mental disorders, or mental disorders due to a general medical condition. Any neurological or neurodegenerative disorders.
•Any current diagnosis of substance abuse or dependence.
•Serious risk of suicide.
•Patients with thyroid conditions.
•Intolerance to or inefficacy of vortioxetine in the past. Patients who had failed treatment with vortioxetine were also excluded.
•Pregnant or breastfeeding female.