Cognitive Effects of Adjuvant Vortioxetine in Early Schizophrenia

Negative Symptoms With Primary Psychotic Disorder Clinical Trial

— CAVES  

Official title:

Cognitive Effects of Adjuvant Vortioxetine in Early Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04895488
• Other study ID #: CAVES
• Secondary ID: 2021-001333-38
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 20, 2022
• Est. completion date: December 20, 2025

Study information

• Verified date: February 2024
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: Clara M. Rosso Fernández, PhD
• Phone: +34 955 013414
• Email: claram.rosso.sspa[@]juntadeandalucia.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: December 20, 2025
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Negative Symptoms With Primary Psychotic Disorder
• Psychotic Disorders
• Schizophrenia

Intervention

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
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen del Rocío	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To assess the effectiveness of Vortioxetine vs. TAU measured by the change in general functioning	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
Other	To assess the safety of Vortioxetine measured through the communication of any serious adverse event.	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
Primary	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	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.	Baseline, week 4, week 12, week 24, week 26, week 30, week 38 and week 50