2024-519778-38-00RecruitingPhase 2/3
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.
Cognitive effects of adjuntive Vortioxetine in early Schizophrenia
Source: EU CTIS (euclinicaltrials.eu) · Last updated 6 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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]
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 37 (estimated)
- First submitted
- 26 Nov 2024
- Start date
- 2 Dec 2024
- Lead sponsor
- Fundacion Para La Gestion De La Investigacion En Salud De Sevilla
- Diseases
- Schizophrenia
- EU CT number
- 2024-519778-38-00
- EudraCT number
- 2021-001333-38
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 37
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adult outpatients with a recent diagnosis of a schizophrenia spectrum disorder who are on stable antipsychotic medicine. It tests whether adding vortioxetine helps thinking skills.
- Age
- Over 18 up to 50 years old (the registry also lists a maximum age of 64 years).
- Sex
- All sexes. Women must agree not to try to become pregnant and must use highly effective contraception.
- Disease stage
- Schizophrenia spectrum disorder confirmed by a structured interview (DSM - SCID). Negative symptom score above 14 on the PANSS scale, with at least two items at level 4 or more. Positive symptom score of 14 or less, with no more than one item at level 4 or more. Depression score (HAMD-17) of 12 or less. Must be an outpatient.
- Earlier treatment
- Stable dose of a second generation antipsychotic (not clozapine) for at least 4 weeks. No antidepressant for at least 8 weeks before randomization.
Main reasons for not taking part
- Taking an antidepressant that cannot be stopped at least 8 weeks before randomization
- Brain structure disease, organic mental disorder, or neurological disorder
- Intellectual disability with an estimated IQ below 70
- Current substance abuse or dependence, or serious risk of suicide
- Pregnant or breastfeeding, thyroid conditions, or past intolerance or failure of vortioxetine
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Virgen Del Rocio S.L. | Sevilla | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.