Neuroinflammation, Affective and Cognitive Symptoms in Major Depression and Psoriasis

NCT04423471 | Withdrawn

• 1 other identifier: PI-16-150
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Psoriasis; Neuroinflammation; Major Depressive Disorder; Cognitive Symptom; Immunological Abnormality

Keywords

Neuroinflammation; Depression; Psoriasis

Outcome Measures

Primary Outcomes (2)

• Correlation between immunological markers and affective and cognitive symptoms at baseline.

  To evaluate the relationship of psychiatric symptoms (affective symptoms, fatigue, cognitive deficits) and markers of inflammation, HPA axis, oxidative and nitrosative stress, gliosis and neurogenesis in both groups of psoriasic and depressive patients.

  Baseline

• Changes in immunological markers and affective and cognitive symptoms between baseline and after 4 months of treatment.

  To evaluate the changes of psychiatric symptoms (affective symptoms, fatigue, cognitive deficits) and markers of inflammation, HPA axis, oxidative and nitrosative stress, gliosis and neurogenesis, after treatment for psoriasis with systemic or biological treatment of psoriasis and with antidepressant treatment for major depression.

  Baseline and at 4 months

Secondary Outcomes (2)

• Correlation between immunological markers and the course of psychiatric comorbidity in relation to anti-inflammatory treatments

  Baseline and at 4 months

• Correlation between the course of major depression with antidepressant treatment and biomarkers of inflammation

  Baseline and at 4 months

Study Arms (3)

Group 1

Psoriasis patients who will receive systemic treatment (mainly methotrexate)

Diagnostic Test: Sociodemographic variables

Group 2

Psoriasis patients who will receive a biological treatment

Diagnostic Test: Sociodemographic variables

Group 3

Patients with major depression who will receive an antidepressant treatment

Diagnostic Test: Sociodemographic variables

Interventions

Sociodemographic variables DIAGNOSTIC_TEST

* 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

Also known as: General clinical variables, Clinical psoriasis variables, Clinical depression variables, Psychopathological variables, Immunological and biochemical variables, Result variables

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subjects that will participate in this study will be outpatients treated in the External Dermatology Consultations and the External Psychiatric Consultations of the Germans Trias i Pujol University Hospital (Badalona, Spain), clinically diagnosed with psoriasis or major depression.

You may qualify if:

• Age between 18 and 65
• Clinical diagnosis of:
• In the psoriasis group: diagnosis of plaque psoriasis made by a dermatologist, lasting at least 6 months.
• In the major depression group: clinical diagnosis of major depression according to DSM-5 criteria made by a psychiatrist.
• Patients receiving systemic or biological treatment for psoriasis, or antidepressant for major depression.

You may not qualify if:

• Previous treatments for psoriasis
• UVBBE phototherapy in the last 2 weeks
• PUVA phototherapy in the last 4 weeks
• Conventional systemic treatments in the last 4 weeks
• Biological treatments in the last 3 months
• Previous antidepressant treatments in the last 6 weeks
• Antipsychotic or eutimizing treatments in the last 6 weeks
• The presence of concurrent psychotic symptoms
• Alcohol or drug use disorders, with active consumption during the last 3 months
• Pregnant women
• Serious and / or unstable medical disorders, Addison or Cushing's disease, Rheumatoid arthritis or systemic lupus erythematosus.

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead

Study Sites (1)

Hospital Universitari Germans Trias i Pujol

Badalona, Catalonia, 08916, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

A blood collection will be performed to collect serum and PBMC (peripheral blood mononuclear cells). Serum samples will be centrifuged at 1750 rpm for 10 minutes, the supernatant will be collected and frozen at -20 ° C. For PBMC, Ficoll gradient centrifugation of blood samples with anticoagulant will be carried out. Once the PBMCs are separated, they will be frozen with 20% DMSO in RPMI culture doctor with 20% fetal calf serum (FCS) and stored in liquid nitrogen. Blood samples will also be obtained for the total extraction of RNA with 3 ml of Paxgene® tubes, processed and frozen at -80 ° C

MeSH Terms

Conditions

Psoriasis; Neuroinflammatory Diseases; Depressive Disorder, Major; Neurobehavioral Manifestations; Depression

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Crisanto Díez-Quevedo, MD, PhD

  Germans Trias i Pujol Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: June 9, 2020
• Study Start: February 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 28, 2022

Record last verified: 2022-01

Locations

ES (1)