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COMPLETED
NCT04418570
NA

Hormonal and Inflammatory Biomarkers and Response to Cognitive Remediation in Recent-onset Psychosis

Sponsor: Corporacion Parc Tauli

View on ClinicalTrials.gov

Summary

This study aims to explore whether hormones or inflammatory markers are associated with cognitive changes following cognitive remediation therapy (CRT) in people with a recent-onset psychotic disorder. The following biomarkers for treatment response will be considered: hormones related to the hypothalamic-pituitary-adrenal (HPA) axis (plasma cortisol, cortisol awakening response, diurnal cortisol slope, salivary cortisol at assessment), free thyroxine (F-T4), prolactin, or inflammatory markers. This study was designed as a pilot clinical trial in order to know the feasibility of the intervention and to calculate the effect sizes of different hormonal and inflammatory variables on cognition. This approach would allow the design of future larger clinical trials to test specific hypotheses generated with this study.

Official title: Hormonal and Inflammatory Biomarkers and Response to a Cognitive Remediation Therapy in Recent-onset Psychosis: Randomized, Cross-over, Single-blind, Pilot Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2016-07

Completion Date

2020-03

Last Updated

2026-10-19

Healthy Volunteers

No

Interventions

BEHAVIORAL

cognitive remediation

OTHER

attendance to an Early Intervention Service for Psychosis