NCT03920475 (INFLAME-D) is a clinical trial of Sertraline or venlafaxine in Depressive Disorder, sponsored by Kliniken Essen-Mitte.

Who is sponsoring NCT03920475?

NCT03920475 is sponsored by Kliniken Essen-Mitte.

What drugs are being tested in NCT03920475?

Interventions in NCT03920475: Sertraline or venlafaxine, Immune parameters.

What condition does NCT03920475 study?

NCT03920475 studies Depressive Disorder, Depression, Inflammation.

Is NCT03920475 still recruiting?

NCT03920475 is currently completed. Last updated 12 February 2020.

Last reviewed 2020-02-12 · How we verify

NCT03920475: INFLAME-D

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The Role of Inflammatory Processes in Development and Treatment of Depression

Completed Last updated 12 February 2020

What this trial tests

trial testing Sertraline or venlafaxine in Depressive Disorder in 104 participants. Completed in 6 March 2018.

Timeline

5 August 2015

Primary endpoint
6 March 2018

6 March 2018

Quick facts

Lead sponsor	Kliniken Essen-Mitte
Status	Completed
Study type	OBSERVATIONAL
Enrollment	104
Start date	5 August 2015
Primary completion	6 March 2018
Estimated completion	6 March 2018

Drugs / interventions tested

Sertraline or venlafaxine — full drug profile →
Immune parameters

Conditions studied

Depressive Disorder — all drugs for Depressive Disorder →
Depression — all drugs for Depression →
Inflammation — all drugs for Inflammation →

Sponsor

Kliniken Essen-Mitte — full company profile →

Who can join

Adults 18 to 65, any sex, with Depressive Disorder or Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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. 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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other Kliniken Essen-Mitte trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03920475 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Kliniken Essen-Mitte
Last refreshed: 12 February 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03920475.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing