The Role of Inflammatory Processes in Development and Treatment of Depression

NCT03920475 | Completed

• 1 other identifier: EssenMitte
• Study Type: observational
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study investigates the influence of inflammatory processes on the development and the course of uni- and bipolar depression. It is assumed, that the concentrations of certain inflammatory proteins have an influence on the development of depression, its clinical severity, the response to treatment and the risk of relapse. To verify this hypothesis, a total of 145 patients, which were hospitalized für treatment of a depressive disorder in the study centers in Germany, Italy and France, were screened according to the criteria set out in the study protocol. Finally, 104 patients with moderate to severe depressive symptoms were included in the study. These patients were treated according to the recommendations of the DGPPN treatment guidelines. All patients received a medication with sertraline or venlafaxine during the study, starting at baseline. The patients were examined for the presence and severity of depressive symptoms at the time of study enrollment, as well as after 4 and 8 weeks, using standardized clinical test procedures. In addition blood was taken. In the serum of the patients, the concentrations of specific inflammatory proteins were measured using Cytometric Bead Array (CBA) and Enzyme-linked Immunosorbent Assay (ELISA) and then correlated with the clinical data. The investigated proteins include high-sensitivity CRP (C-Reactive-Protein), Interleukin 4, Interleukin 6, Interleukin 12, tumor necrosis factor-α, Eotaxin, Intercellular adhesion molecule 1 (CD54), Interferone-gamma and monocyte chemotactic protein 1 (MCP-1).

Conditions

Depressive Disorder; Depression; Inflammation

Outcome Measures

Primary Outcomes (1)

• Change in severity of depressive symptoms

  Measurement of depressive symptoms using the Montgomery-Asberg Depression Rating Scale. The scale measures the severity of depression-associated symptoms. The usual cutoff points are 0 to 6 - depression absent, 7 to 19 - mild depression, 20 to 34 - moderate depression, \>34 severe depression

  4 and 8 weeks after enrollment in the study

Secondary Outcomes (1)

• Changes in serum-concentration of inflammatory proteins

  4 and 8 weeks after enrollment in the stuy

Study Arms (1)

TAU (treatment as usual) group

Patients with depression, meeting inclusion criteria, who needed antidepressant treatment and received either sertraline or venlafaxine.

Drug: Sertraline or venlafaxine; Diagnostic Test: Immune parameters

Interventions

Sertraline or venlafaxine DRUG

Patients were treated as needed with sertraline or venlafaxine following the official guidelines, starting with a dose of 25 mg/d or respectively 37,5 mg/day. The starting dose could be increased during the course of the treatment as clinically needed according to guide lines.

TAU (treatment as usual) group

Immune parameters DIAGNOSTIC_TEST

Serum was taken before, during an after treatment for measurement of different immune parameters.

TAU (treatment as usual) group

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

Patients with pharmacological treatment of depressive symptoms (out- or inpatient treatment).

You may qualify if:

• Patients with uni- or bipolar depression, diagnosed according to the criteria of the Diagnostic and Statistical Manual Version IV (DSM-IV) via Mini-international neuropsychiatric interview Version 6.0 (MINI 6.0) diagnostic tool.

You may not qualify if:

• Patients with severe somatic, rheumatic, endocrine or neurological comorbidities. This includes in particular neurological disorders associated with cognitive disorder, severe liver, kidney and cardiac diseases.
• Patients, who are being treated permanently with anti-inflammatory or immunosuppressive drugs (e.g. corticosteroids or alpha / beta-a(nta)gonists, immuno suppressant drugs).
• Patients with severe psychiatric disorders (Axis I) such as schizophrenia, dementia, attention deficit hyperactivity disorder, obsessive-compulsive disorder, current alcohol, drugs or drug addiction.
• Patients who have already been treated unsuccessfully with sertraline and all alternate medications allowed in the study.
• Pregnant or lactating (breast feeding) women.

Sponsors & Collaborators

• Kliniken Essen-Mitte: lead
• University of Bordeaux: collaborator
• IRCCS Centro San Giovanni di Dio Fatebenefratelli: collaborator
• Ruhr University of Bochum: collaborator
• National Research Agency, France: collaborator
• Créteil Hospital: collaborator
• German Federal Ministry of Education and Research: collaborator
• Ministry of Health, Italy: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, edta, RNA-pax tubes

MeSH Terms

Conditions

Depressive Disorder; Depression; Inflammation

Interventions

Sertraline; Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Phenethylamines; Ethylamines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Lipids

Study Officials

• Martin Schäfer

  Kliniken Essen-Mitte

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 19, 2019
• Study Start: August 5, 2015
• Primary Completion: March 6, 2018
• Study Completion: March 6, 2018
• Last Updated: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: starting 6 months after publication
• Access Criteria: the data will be provided for the purpose of meta-analysis to scientific groups and researchers after personal request via the office of the studies director Prof. Martin Schäfer.