Clinical trial NCT04895488: Cognitive Effects of Adjuvant Vortioxetine in Early Schizophrenia
Official title: Cognitive Effects of Adjuvant Vortioxetine in Early Schizophrenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Cognitive Impairment With Primary Psychotic Disorder
Negative Symptoms With Primary Psychotic Disorder
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A two arm, Open-label, randomized, Cross-over Design and single-center clinical trial Phase II b /Phase III.
Primary purpose: TREATMENT

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 symptoms severity in early schizophrenia.

Eligibility 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.

Primary outcomes:
measure: To assess the effectiveness of Vortioxetine vs. TAU measured by the change in Brief Assessment of Cognition in Schizophrenia (BACS App) scores
timeFrame: Baseline, week 24, week 26 and week 50
Secondary outcomes:
measure: To assess the effectiveness of Vortioxetine vs. TAU measured by the change in Negative Symptoms severity (Scale for Assessment of Negative Symptoms (SANS) and Negative Symptom Assessment-4 (NSA-4) total scores)
timeFrame: Baseline, week 4, week 12, week 24, week 26, week 30, week 38 and week 50
Other outcomes:
measure: To assess the effectiveness of Vortioxetine vs. TAU measured by the change in general functioning
timeFrame: baseline, week 12, week 24, week 26, week 38 and week 50
measure: To assess the safety of Vortioxetine measured through the communication of any serious adverse event.
timeFrame: from informed consent form (ICF) signature to 52 weeks
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
affiliation: benedicto.crespo.sspa@juntadeandalucia.es
name: Benedicto Crespo Facorro, Professor
role: PRINCIPAL_INVESTIGATOR
References: