Depressive DisorderINFLAME-DNCT03920475
The Role of Inflammatory Processes in Development and Treatment of Depression
An observational study of Depressive Disorder and Depression, run by Kliniken Essen-Mitte.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Depression, Inflammation
- What is being tested?
- Sertraline or venlafaxine and Immune parameters
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 5 Aug 2015to 6 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pharmacological treatment of depressive symptoms (out- or inpatient treatment).
Who may be able to join
- Patients with uni- or bipolar depression, diagnosed according to the criteria of the Diagnostic and Statistical Manual Version IV (DSM-IV) via Mini-international neuropsychiatric interview Version 6.0 (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-Asberg Depression Scale.
Who cannot join
- 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, attention deficit hyperactivity disorder, 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.
About this study
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.
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).
Read the 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).
- Conditions
- Depressive Disorder, Depression, Inflammation
- Being tested
- Sertraline or venlafaxine, Immune parameters
- Medical subject headings
- Depressive Disorder, Depression, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sertraline or venlafaxineDrug
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.
Immune parametersDiagnostic test
Serum was taken before, during an after treatment for measurement of different immune parameters.
| Study group | Role | What they receive |
|---|---|---|
| TAU (treatment as usual) group | Patients with depression, meeting inclusion criteria, who needed antidepressant treatment and received either sertraline or venlafaxine. Receives: Drug: Sertraline or venlafaxine; Diagnostic Test: Immune parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 and 8 weeks after enrollment in the study
Secondary outcomes (1)
Changes in serum-concentration of inflammatory proteins
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.
Measured: 4 and 8 weeks after enrollment in the stuy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start5 Aug 2015
- Primary completion6 Mar 2018
- Study completion6 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kliniken Essen-Mitte
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Martin Schäfer, Study director, Kliniken Essen-Mitte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920475
- Sponsor's protocol ID
- EssenMitte
- Acronym
- INFLAME-D
- Status last verified
- Feb 2020
- First submitted
- 16 Apr 2019
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data (IPD) completely anonymized
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03920475
- Acronym / sponsor ID
- INFLAME-D / EssenMitte
- Conditions
- Depressive Disorder, Depression, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Kliniken Essen-MitteUniversity, hospital or other
- 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
- Study start
- 5 Aug 2015 (actual)
- Primary completion
- 6 Mar 2018 (actual)
- Study completion
- 6 Mar 2018 (actual)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAU (treatment as usual) group | – | Drug: Sertraline or venlafaxine, Diagnostic Test: Immune parametersPatients with depression, meeting inclusion criteria, who needed antidepressant treatment and received either sertraline or venlafaxine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pharmacological treatment of depressive symptoms (out- or inpatient treatment).
Key inclusion criteria (2 listed)
- Patients with uni- or bipolar depression, diagnosed according to the criteria of the Diagnostic and Statistical Manual Version IV (DSM-IV) via Mini-international neuropsychiatric interview Version 6.0 (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-Asberg Depression Scale.
Key exclusion criteria (5 listed)
- 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, attention deficit hyperactivity disorder, 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sertraline or venlafaxinePatients 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. | Drug | TAU (treatment as usual) group |
| Immune parametersSerum was taken before, during an after treatment for measurement of different immune parameters. | Diagnostic test | TAU (treatment as usual) group |
Primary outcome
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
1 secondary outcome
Changes in serum-concentration of inflammatory proteins
Time frame: 4 and 8 weeks after enrollment in the stuy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Individual participant dataSharing planned: Yes. Individual patient data (IPD) completely anonymized
Related trials for Depressive Disorder
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Schäfer study director
Kliniken Essen-Mitte
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder and Depression, run by Kliniken Essen-Mitte.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in severity of depressive symptoms (time frame: 4 and 8 weeks after enrollment in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.