Cognitive Effects of Adjuvant Vortioxetine in Early Schizophrenia (CAVES)

February 22, 2024 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Clinical trial to assess the efficacy of Vortioxetine compared with treatment as usual in early schizophrenia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

37

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen Del Rocio
        • Contact:
        • Principal Investigator:
          • Benedicto Crespo Facorro, Professor
        • Sub-Investigator:
          • Miguel Ruiz Veguilla, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: Vortioxetine+Usual antipsychotic treatment (TAU)

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

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

Drug: Usual Antipsychotic Treatment
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.
Other Names:
  • TAU
Active Comparator: Arm B: Usual antipsychotic treatment (TAU)
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

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

Drug: Usual Antipsychotic Treatment
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.
Other Names:
  • TAU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the effectiveness of Vortioxetine vs. TAU measured by the change in Brief Assessment of Cognition in Schizophrenia (BACS App) scores
Time Frame: Baseline, week 24, week 26 and week 50
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: Baseline, week 4, week 12, week 24, week 26, week 30, week 38 and week 50
To assess the effectiveness of Vortioxetine vs. TAU in the treatment of negative symptoms in early psychosis, measured by the change in Negative Symptoms severity (SANS, NSA-4 total scores) from baseline to end of trial.
Baseline, week 4, week 12, week 24, week 26, week 30, week 38 and week 50

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the effectiveness of Vortioxetine vs. TAU measured by the change in general functioning
Time Frame: baseline, week 12, week 24, week 26, week 38 and week 50
To assess the effectiveness of Vortioxetine vs. TAU in the treatment of cognitive impairments in early psychosis, measured by the change in general functioning (Global Assessment of Functioning (GAF) total score)
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.
Time Frame: from informed consent form (ICF) signature to 52 weeks
To assess the safety of Vortioxetine in patients with early psychosis measured through the communication of any serious adverse event evaluated for relationship with the Investigational Medicinal Product (IMP).
from informed consent form (ICF) signature to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Investigators

  • Principal Investigator: Benedicto Crespo Facorro, Professor, benedicto.crespo.sspa@juntadeandalucia.es

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2022

Primary Completion (Estimated)

December 20, 2024

Study Completion (Estimated)

December 20, 2025

Study Registration Dates

First Submitted

May 17, 2021

First Submitted That Met QC Criteria

May 17, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Estimated)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAVES
  • 2021-001333-38 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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