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Completed
NCT04418570
Hormonal and Inflammatory Biomarkers and Response to Cognitive Remediation in Recent-onset Psychosis
Conditions: Psychotic Disorders
Sex: All
Ages: 18 Years – 40 Years
Healthy volunteers: No
Phase: NA
Enrollment: 28
Sponsor: Corporacion Parc Tauli
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.
Eligibility Criteria
Inclusion Criteria:
* Psychotic disorder meeting Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) criteria for any of the following diagnoses: schizophrenia, schizoaffective disorder, bipolar disorder, and psychotic disorder not otherwise specified.
* Recent-onset psychosis (\< 3 years of illness).
* Outpatients with stable illness (\
Source: ClinicalTrials.gov (NCT04418570). StuddyBuddy aggregates publicly available trial information.