Effects of Vortioxetine on cognitive function in early schizophrenia
Cognitive Effects of Adjuvant Vortioxetine in Early Schizophrenia
This study is testing if a medication called Vortioxetine can help improve thinking skills and reduce negative symptoms in young adults with early schizophrenia compared to standard treatments.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 37 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla Academic / other |
| Locations | 1 site (Sevilla) |
| Trial ID | NCT04895488 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of Vortioxetine in improving cognitive functioning and reducing negative symptoms in patients with early schizophrenia. Participants will receive either Vortioxetine or standard antipsychotic treatment, with assessments focused on cognitive impairment and symptom severity. The study aims to determine if Vortioxetine offers significant benefits over usual care in this population. It includes outpatient individuals aged 18-50 who meet specific diagnostic criteria and have stable antipsychotic medication.
Who should consider this trial
Good fit: Ideal candidates are outpatients aged 18-50 with a diagnosis of schizophrenia spectrum disorders and specific symptom profiles.
Not a fit: Patients with severe symptoms or those currently on antidepressant treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance cognitive function and alleviate negative symptoms in patients with early schizophrenia.
How similar studies have performed: Other studies have shown promise in using Vortioxetine for cognitive impairment, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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: 1. 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.
Where this trial is running
Sevilla
- Hospital Universitario Virgen del Rocío — Sevilla, Spain (Recruiting)
Study contacts
- Principal investigator: Benedicto Crespo Facorro, Professor — benedicto.crespo.sspa@juntadeandalucia.es
- Study coordinator: Clara M. Rosso Fernández, PhD
- Email: claram.rosso.sspa@juntadeandalucia.es
- Phone: +34 955 013414
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.