Depression Clinical Trial
Official title:
An Investigation of the Role of Inflammatory Processes in the Development and Treatment of Idiopathic Unipolar and Bipolar Depression in Patients With Moderate to Severe Depressive Symptoms.
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).
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. The severity of the symptoms was classified using well-established
clinical rating scales like Montgomery-Asberg Depression Rating Scale (MADRS) and Hamilton
rating scale for depression (HAMD). All enrolled patients were treated according to the
recommendations of the German Association for Psychiatry, Psychotherapy and Psychosomatics
(DGPPN) treatment guidelines.
In order to make drug-induced changes in the serum concentrations of the examined proteins as
comparable as possible, it was determined in advance, that all patients should be treated
with either sertraline (first choice) or venlafaxine (second choice) as an oral
antidepressant. Apart from that, the antidepressive therapy, ie psychotherapy and similar
procedures, had not been standardized. The treatment of study participants did not differ
from the treatment of other patients hospitalized because of depression, who did not
participate in the study. 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).
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