The Role of Inflammatory Processes in Development and Treatment of Depression

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

Interventions

DRUG

Sertraline or venlafaxine

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.

DIAGNOSTIC_TEST

Immune parameters

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

Sponsors & Collaborators

• University of Bordeaux

  collaborator OTHER

• IRCCS Centro San Giovanni di Dio Fatebenefratelli

  collaborator OTHER

• Ruhr University of Bochum

  collaborator OTHER

• National Research Agency, France

  collaborator OTHER

• Créteil Hospital

  collaborator OTHER

• German Federal Ministry of Education and Research

  collaborator OTHER_GOV

• Ministry of Health, Italy

  collaborator OTHER_GOV

• Kliniken Essen-Mitte

  lead OTHER

Principal Investigators

• Martin Schäfer · Kliniken Essen-Mitte

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-08-05

Primary Completion

2018-03-06

Completion

2018-03-06