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Trial record 13 of 2657 for:    "Depressive Disorder" [DISEASE] AND depressive symptoms

The Role of Inflammatory Processes in Development and Treatment of Depression (INFLAME-D)

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ClinicalTrials.gov Identifier: NCT03920475
Recruitment Status : Completed
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Collaborators:
University of Bordeaux
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Ruhr University of Bochum
National Research Agency, France
Créteil Hospital
German Federal Ministry of Education and Research
Ministry of Health, Italy
Information provided by (Responsible Party):
Kliniken Essen-Mitte

Brief 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 and ELISA and then correlated with the clinical data. The investigated proteins include high-sensitivity CRP, Interleukin 4, Interleukin 6, Interleukin 12, TNF-α, Eotaxin, CD54, Interferone-gamma and MCP-1.

Condition or disease Intervention/treatment
Depressive Disorder Depression Inflammation Drug: Sertraline or venlafaxine Diagnostic Test: Immune parameters

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 MADRS and HAMD17. All enrolled patients were treated according to the recommendations of the 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 and ELISA and then correlated with the clinical data. The investigated proteins include high-sensitivity CRP, Interleukin 4, Interleukin 6, Interleukin 12, TNF-α, Eotaxin, CD54, Interferone-gamma and MCP-1.


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Study Type : Observational
Actual Enrollment : 104 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
TAU 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.




Primary Outcome Measures :
  1. Change in severity of depressive symptoms [ Time Frame: 4 and 8 weeks after enrollment in the stuy ]
    measurement of depressive symptoms using the Montgomery-Åsberg Depression Rating Scale


Secondary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
whole blood, serum, edta, RNA-pax tubes


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with pharmacological treatment of depressive symptoms (out- or inpatient treatment).
Criteria

Inclusion Criteria:

  • Patients with uni- or bipolar depression, diagnosed according to the criteria of the DSM-IV via MINI 6.0 diagnostic tool.
  • At the time of inclusion in the study, the symptoms must meet at least the requirements of a moderately severe depression, defined by a minimum score of ≥ 22 on the Montgomery-Åsberg Depression Scale.

Exclusion Criteria:

  • Patients with severe somatic, rheumatic, endocrine or neurological comorbidities. This includes in particular neurological disorders associated with cognitive disorder, severe liver, kidney and cardiac diseases.
  • Patients, who are being treated permanently with anti-inflammatory or immunosuppressive drugs (e.g. corticosteroids or alpha / beta-a(nta)gonists, immuno suppressant drugs).
  • Patients with severe psychiatric disorders (Axis I) such as schizophrenia, dementia, ADHD, obsessive-compulsive disorder, current alcohol, drugs or drug addiction.
  • Patients who have already been treated unsuccessfully with sertraline and all alternate medications allowed in the study.
  • Pregnant or lactating (breast feeding) women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920475


Sponsors and Collaborators
Kliniken Essen-Mitte
University of Bordeaux
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Ruhr University of Bochum
National Research Agency, France
Créteil Hospital
German Federal Ministry of Education and Research
Ministry of Health, Italy
Investigators
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Study Director: Martin Schäfer Kliniken Essen-Mitte

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Responsible Party: Kliniken Essen-Mitte
ClinicalTrials.gov Identifier: NCT03920475     History of Changes
Other Study ID Numbers: EssenMitte
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD completely anonymized
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: starting 6 months after publication
Access Criteria: the data will be provided for the purpose of meta-analysis to scientific groups and researchers after personal request via the office of the studies director Prof. Martin Schäfer.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Inflammation
Mood Disorders
Mental Disorders
Pathologic Processes
Sertraline
Venlafaxine Hydrochloride
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Serotonin and Noradrenaline Reuptake Inhibitors
Antidepressive Agents, Second-Generation