The Role of Inflammatory Processes in Development and Treatment of Depression
Condition: Depressive Disorder; Depression; Inflammation
MeSH terms: Inflammation; Depression; Depressive Disorder
Study type: Observational

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).
    

Detailed description: 
      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).
    

Intervention name(s): Sertraline or venlafaxine; Immune parameters
Intervention type(s): Drug; Diagnostic Test
Intervention description(s): 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.; Serum was taken before, during an after treatment for measurement of different immune parameters.
Intervention MeSH terms: Sertraline; Venlafaxine Hydrochloride
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with pharmacological treatment of depressive symptoms (out- or inpatient
        treatment).
      
Biospecimen description: 
      whole blood, serum, edta, RNA-pax tubes