Status:
RECRUITING
Cognitive Effects of Adjuvant Vortioxetine in Early Schizophrenia
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Conditions:
Cognitive Impairment With Primary Psychotic Disorder
Negative Symptoms With Primary Psychotic Disorder
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
PHASE3
Brief Summary
Clinical trial to assess the efficacy of Vortioxetine compared with treatment as usual in early schizophrenia.
Detailed Description
Clinical trial to assess the efficacy of Vortioxetine, compared with treatment as usual in early schizophrenia. Propose: To investigate the effect of Vortioxetine in cognitive functioning and negative...
Eligibility Criteria
Inclusion
- Outpatient
- 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
- 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.
- 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.
Key Trial Info
Start Date :
January 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2025
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04895488
Start Date
January 20 2022
End Date
December 20 2025
Last Update
February 26 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario Virgen del Rocío
Seville, Spain, 41013