NCT04895488

Cognitive Effects of Adjuvant Vortioxetine in Early Schizophrenia

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-20
• Primary completion: 2024-12-20
• Completion: 2025-12-20
• First posted: 2021-05-20
• Last updated: 2024-02-26

Locations

1 site across 1 country: Spain