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.
Key facts
- Where
- Sevilla, SpanyolországSee the site
- Phase
- 2/3. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Spanyolország
- University Hospital Virgen Del Rocio S.L.Sevilla, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundacion Para La Gestion De La Investigacion En Salud De Sevilla
- Trial code
- EU 2024-519778-38-00
- Record updated
- 2025. március 6.
- Original description
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]Read full original descriptionShow less
Cognitive effects of adjuntive Vortioxetine in early Schizophrenia
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]
Inclusion: 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: 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.