Cognitive Effects of Adjuvant Vortioxetine in Early Schizophrenia

NCT04895488 | Recruiting Phase 2 DMC

• 2 other identifiers: CAVES2021-001333-38
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical trial to assess the efficacy of Vortioxetine compared with treatment as usual in early schizophrenia.

Conditions

Cognitive Impairment With Primary Psychotic Disorder; Negative Symptoms With Primary Psychotic Disorder

Outcome Measures

Primary Outcomes (1)

• To assess the effectiveness of Vortioxetine vs. TAU measured by the change in Brief Assessment of Cognition in Schizophrenia (BACS App) scores

  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 BACS App scores using the Composite Z-score Defined as the Weighted Sum of the Individual Patient Z-scores

  Baseline, week 24, week 26 and week 50

Secondary Outcomes (1)

• 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)

  Baseline, week 4, week 12, week 24, week 26, week 30, week 38 and week 50

Other Outcomes (2)

• To assess the effectiveness of Vortioxetine vs. TAU measured by the change in general functioning

  baseline, week 12, week 24, week 26, week 38 and week 50

• To assess the safety of Vortioxetine measured through the communication of any serious adverse event.

  from informed consent form (ICF) signature to 52 weeks

Study Arms (2)

Arm A: Vortioxetine+Usual antipsychotic treatment (TAU)

EXPERIMENTAL

Drug: First treatment phase: Vortioxetine 10 mg 1 tablet/d for 2 weeks added to Usual antipsychotic treatment, followed by Vortioxetine 20mg 1tablet/d for 22 weeks added to Usual antipsychotic treatment. Wash-out period 2 weeks

Drug: Vortioxetine; Drug: Usual Antipsychotic Treatment

Arm B: Usual antipsychotic treatment (TAU)

ACTIVE COMPARATOR

Second treatment phase: Usual antipsychotic treatment: Allows for whatever medication, routine support, or referral to other services was felt appropriate by the clinician.

Drug: Vortioxetine; Drug: Usual Antipsychotic Treatment

Interventions

Vortioxetine DRUG

First treatment phase: vortioxetine will be initiated at 10 mg / day for 2 weeks, followed by 20 mg /day for 22 weeks. The dose of vortioxetine can be lowered to 5 mg or 10 mg for tolerability reasons at clinician criteria. Wash-out period 2 weeks

Arm A: Vortioxetine+Usual antipsychotic treatment (TAU); Arm B: Usual antipsychotic treatment (TAU)

Usual Antipsychotic Treatment DRUG

Second treatment phase. Usual antipsychotic treatment for 26 weeks: Allows for whatever medication, routine support, or referral to other services was felt appropriate by the clinician.

Also known as: TAU

Arm A: Vortioxetine+Usual antipsychotic treatment (TAU); Arm B: Usual antipsychotic treatment (TAU)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

RECRUITING

MeSH Terms

Interventions

Vortioxetine

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Benedicto Crespo Facorro, Professor

  benedicto.crespo.sspa@juntadeandalucia.es

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clara M. Rosso Fernández, PhD

CONTACT

+34 955 013414; claram.rosso.sspa@juntadeandalucia.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A two arm, Open-label, randomized, Cross-over Design and single-center clinical trial Phase II b /Phase III.

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 20, 2021
• Study Start: January 20, 2022
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2025
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

ES (1)