The Role of Inflammatory Processes in Development and Treatment of Depression (INFLAME-D)
|ClinicalTrials.gov Identifier: NCT03920475|
Recruitment Status : Completed
First Posted : April 19, 2019
Last Update Posted : February 12, 2020
|Condition or disease||Intervention/treatment|
|Depressive Disorder Depression Inflammation||Drug: Sertraline or venlafaxine Diagnostic Test: Immune parameters|
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).
|Study Type :||Observational|
|Actual Enrollment :||104 participants|
|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.|
|Actual Study Start Date :||August 5, 2015|
|Actual Primary Completion Date :||March 6, 2018|
|Actual Study Completion Date :||March 6, 2018|
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
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.
- Change in severity of depressive symptoms [ Time Frame: 4 and 8 weeks after enrollment in the study ]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
- Changes in serum-concentration of inflammatory proteins [ Time Frame: 4 and 8 weeks after enrollment in the stuy ]measurement of inflammatory proteins as listed in description of the study: 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). All results are given in the unit pg/ml.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920475
|Study Director:||Martin Schäfer||Kliniken Essen-Mitte|