Overview

Cognitive Effects of Adjuvant Vortioxetine in Early Schizophrenia

Status:
Not yet recruiting
Trial end date:
2025-12-15
Target enrollment:
0
Participant gender:
All
Summary
Clinical trial to assess the efficacy of Vortioxetine compared with treatment as usual in early schizophrenia.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Treatments:
Antipsychotic Agents
Vortioxetine
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 /=4
(moderate)

8. Hamilton Depression Rating Scale (HAMD-17) total score
9. Simpson Angus Score of any item <2

10. Behaviorally Anchored Rating Scale (BARS) of any item
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.