Cognitive Effects of Adjuvant Vortioxetine in Early Schizophrenia

NCT ID: NCT04895488

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-20
• Study Completion Date: 2025-12-20

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Vortioxetine

Intervention Type: 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

Usual Antipsychotic Treatment

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Vortioxetine

Intervention Type: 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

Usual Antipsychotic Treatment

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

TAU

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benedicto Crespo Facorro, Professor

Role: PRINCIPAL_INVESTIGATOR

benedicto.crespo.sspa@juntadeandalucia.es

Locations

Hospital Universitario Virgen del Rocío

Seville, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Clara M. Rosso Fernández, PhD

Role: CONTACT

claram.rosso.sspa@juntadeandalucia.es

+34 955 013414

Facility Contacts

Benedicto Crespo Facorro, Professor

Role: primary

benedicto.crespo.sspa@juntadeandalucia.es

+34671596675

Idalino Rocha, MSc

Role: backup

idalino.rocha@juntadeandalucia.es

+34689366067

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2021-001333-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAVES

Identifier Type: -

Identifier Source: org_study_id