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Cognitive Effects of Adjuvant Vortioxetine in Early Schizophrenia (CAVES)

Primary Purpose

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

Status
Not yet recruiting
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Vortioxetine
Usual Antipsychotic Treatment
Sponsored by
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Impairment With Primary Psychotic Disorder

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario Virgen del Rocío

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: Vortioxetine+Usual antipsychotic treatment (TAU)

Arm B: Usual antipsychotic treatment (TAU)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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.

Full Information

First Posted
May 17, 2021
Last Updated
October 15, 2021
Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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1. Study Identification

Unique Protocol Identification Number
NCT04895488
Brief Title
Cognitive Effects of Adjuvant Vortioxetine in Early Schizophrenia
Acronym
CAVES
Official Title
Cognitive Effects of Adjuvant Vortioxetine in Early Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 15, 2021 (Anticipated)
Primary Completion Date
November 15, 2025 (Anticipated)
Study Completion Date
December 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment With Primary Psychotic Disorder, Negative Symptoms With Primary Psychotic Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Model Description
A two arm, Open-label, randomized, Cross-over Design and single-center clinical trial Phase II b /Phase III.
Masking
None (Open Label)
Masking Description
None (Open Label)
Allocation
Randomized
Enrollment
37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Vortioxetine+Usual antipsychotic treatment (TAU)
Arm Type
Experimental
Arm Description
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
Arm Title
Arm B: Usual antipsychotic treatment (TAU)
Arm Type
Active Comparator
Arm Description
Second treatment phase: Usual antipsychotic treatment: Allows for whatever medication, routine support, or referral to other services was felt appropriate by the clinician.
Intervention Type
Drug
Intervention Name(s)
Vortioxetine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Usual Antipsychotic Treatment
Other Intervention Name(s)
TAU
Intervention Description
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.
Primary Outcome Measure Information:
Title
To assess the effectiveness of Vortioxetine vs. TAU measured by the change in Brief Assessment of Cognition in Schizophrenia (BACS App) scores
Description
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
Time Frame
Baseline, week 24, week 26 and week 50
Secondary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Baseline, week 4, week 12, week 24, week 26, week 30, week 38 and week 50
Other Pre-specified Outcome Measures:
Title
To assess the effectiveness of Vortioxetine vs. TAU measured by the change in general functioning
Description
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)
Time Frame
baseline, week 12, week 24, week 26, week 38 and week 50
Title
To assess the safety of Vortioxetine measured through the communication of any serious adverse event.
Description
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).
Time Frame
from informed consent form (ICF) signature to 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clara M. Rosso Fernández, PhD
Phone
+34 955 013414
Email
claram.rosso.sspa@juntadeandalucia.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benedicto Crespo Facorro, Professor
Organizational Affiliation
benedicto.crespo.sspa@juntadeandalucia.es
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benedicto Crespo Facorro, Professor
Phone
+34671596675
Email
benedicto.crespo.sspa@juntadeandalucia.es
First Name & Middle Initial & Last Name & Degree
Idalino Rocha, MSc
Phone
+34689366067
Email
idalino.rocha@juntadeandalucia.es
First Name & Middle Initial & Last Name & Degree
Benedicto Crespo Facorro, Professor
First Name & Middle Initial & Last Name & Degree
Miguel Ruiz Veguilla, PhD

12. IPD Sharing Statement

Learn more about this trial

Cognitive Effects of Adjuvant Vortioxetine in Early Schizophrenia

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