Neuroinflammation, Affective and Cognitive Symptoms in Major Depression and Psoriasis

NCT04423471 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2022-01-28

No results posted yet for this study

Summary

Objectives: To identify peripheral neuroinflammatory markers in patients suffering from major depression or psoriasis in relation to affective symptoms (anxiety, depression, irritability), fatigue and cognitive symptoms; and their change after specific treatments.

Methodology: Observational prospective cohort study in patients diagnosed with major depression and patients with plaque psoriasis, who naturalistically undergo different treatments (systemic or biological for psoriasis, antidepressants for depression). Forty-one patients with major depression attending psychiatric consultations and 82 patients with psoriasis attending dermatology consultations at Hospital Universitari Germans Trias i Pujol aged 18 to 65 years old will be selected for inclusion. All of them will be assessed at baseline and after 4 months treatment through a series of demographic and clinical variables, psychiatric diagnosis, psychopathological scales and immunological and biochemical variables after blood draw for obtaining serum, peripheral blood mononuclear cell (PBMC) and extraction of total RNA. Investigators will analyze the correlation between immunological markers and affective and cognitive symptoms at baseline, as well as their variation after treatment. Subsequently, a bivariate comparative analysis will be carried out, where statistically significant or marginally significant variables associated with psychopathological variables will be used to construct a multivariate model of binary logistic regression.

Conditions

Interventions

DIAGNOSTIC_TEST

Sociodemographic variables

* Sociodemographic variables: Sex / Age / Marital status / Level of studies completed / Employment status. * General clinical variables: Body mass index (BMI), Medical comorbidities and Charlson Comorbidity Index, Active drug treatments * Clinical psoriasis variables: BSA, PASI, ScalpPASI, PPPASI, DLQI, time since the diagnosis of psoriasis, previous treatments for psoriasis. * Clinical depression variables: Psychiatric diagnoses according to clinical interview and DSM-5 criteria, age of onset and time of evolution from the first episode of major depression, time of evolution of the current episode of major depression, previous treatments for depression. * Psychopathological variables: HADS, PHQ-9, MADRS, GAD-7, SHAPS, The Irritability Questionnaire, PSS, FSS, MoCA. * Immunological and biochemical variables: Acute phase biomarkers, Proinflammatory cytokines, Anti-inflammatory cytokines, HPA axis, Microglia activation, Neurogenesis. * Result variables: Changes in PASI or MADRS scores

Sponsors & Collaborators

  • Germans Trias i Pujol Hospital

    lead OTHER

Principal Investigators

  • Crisanto Díez-Quevedo, MD, PhD · Germans Trias i Pujol Hospital

Eligibility

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

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2022-03-31
Completion
2022-12-31

Countries

  • Spain

Study Locations

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Entities

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 NCT04423471 on ClinicalTrials.gov