Clinical trial to study the effect of an already authorized drug on other pathologies by administering it to people with a recent diagnosis of schizophrenia.

Phase 2/3

Not yet recruiting

Lead Sponsor: Fundacion Para La Gestion De La Investigacion En Salud De Sevilla

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]

Recruitment & Eligibility

Inclusion Criteria

Outpatient 2. Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (DSM - SCID) diagnosis of Schizophrenia spectrum disorders. 3. Age >18-50 years old 4. Stable antipsychotic medication doses during at least 4 weeks ( all second generation antipsychotics excluding clozapine). 5. No antidepressant treatment for at least 8 weeks prior to randomization. 6. PANSS Negative subscore >14 with at least two of the items at a level >/=4 (moderate) 7. PANSS Positive subscore </=14 with not more than one of the items at a level >/=4 (moderate) 8. Hamilton Depression Rating Scale (HAMD-17) total score </=12 9. Simpson Angus Score of any item <2 10. Behaviorally Anchored Rating Scale (BARS) of any item </= 1 11. Competent and willing to sign informed consent 12. The patient, if a woman, must: agree not to try to become pregnant during the study and use adequate, highly effective contraception

Exclusion Criteria

Patients taking any antidepressant and its use cannot be discontinued at least 8 weeks prior to randomization. 2. Structural brain disease (based on previous medical records) 3. Cognitive disability by history and estimated intelligence quotient (IQ) <70 (ID DSM-5 diagnosis). 4. 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. 5. Organic mental disorders, or mental disorders due to a general medical condition. Any neurological or neurodegenerative disorders. 6. Any current diagnosis of substance abuse or dependence. 7. Serious risk of suicide. 8. Patients with thyroid conditions. 9. Intolerance to or inefficacy of vortioxetine in the past. Patients who had failed treatment with vortioxetine were also excluded. 10. Pregnant or breastfeeding female.

Primary Outcome Measures

Name	Time	Method
Primary outcome measures: Cognitive functioning improvement assessed by the change in BACS App scores.		Primary outcome measures: Cognitive functioning improvement assessed by the change in BACS App scores.

Secondary Outcome Measures

Name	Time	Method

Locations (1): University Hospital Virgen Del Rocio S.L.
🇪🇸
Sevilla, Spain
University Hospital Virgen Del Rocio S.L.
🇪🇸Sevilla, Spain
Benedicto Crespo Facorro
Site contact
606785632
benedicto.crespo.sspa@juntadeandalucia.es