INFLAME-D
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.
Sponsor study identifier
observational
104
0 countries
N/A
Study Start
August 5, 2015
Actual (reported)Primary Completion
March 6, 2018
Actual (reported)Study Completion
March 6, 2018
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 6, 2018
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 5, 2015
Actual (reported)March 6, 2018
Actual (reported)March 6, 2018
Actual (reported)April 16, 2019
Actual (reported)April 19, 2019
Actual (reported)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
Changes in serum-concentration of inflammatory proteins
4 and 8 weeks after enrollment in the stuy
Patients with depression, meeting inclusion criteria, who needed antidepressant treatment and received either 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.
Serum was taken before, during an after treatment for measurement of different immune parameters.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Sertraline or venlafaxine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordPatients with pharmacological treatment of depressive symptoms (out- or inpatient treatment).
whole blood, serum, edta, RNA-pax tubes
Martin Schäfer
Kliniken Essen-Mitte
104 participants (actual enrollment reported by the registry).
First Submitted
April 16, 2019
First Posted
April 19, 2019
Study Start
August 5, 2015
Actual (reported)Manual-based Art Therapy for Adolescents With Depression
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 6, 2018
Actual (reported)Study Completion
March 6, 2018
Actual (reported)Last Updated
February 12, 2020
Record last verified: 2020-02
Individual patient data (IPD) completely anonymized
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Source: ClinicalTrials.gov.
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