MedTrace Logo

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

NCT04418570 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2020-06-09

No results posted yet for this study

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.

Conditions

  • Psychotic Disorders

Interventions

BEHAVIORAL

cognitive remediation

OTHER

attendance to an Early Intervention Service for Psychosis

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Corporacion Parc Tauli

    lead OTHER

Principal Investigators

  • Javier Labad, M.D., Ph.D. · Parc Taulí Hospital Universitari, Sabadell, Barcelona (Spain).

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2020-03-31
Completion
2020-03-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04418570 on ClinicalTrials.gov