Major Depressive DisorderNCT02871141
Multimodal Imaging of ECT Effects
An observational study of Major Depressive Disorder, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The project aims to investigate markers of neural activity and connectivity, neurochemistry, hypothalamic-pituitary-adrenal (HPA) axis activity, inflammation and neuronal plasticity underlying treatment response and remission after ECT. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- electroconvulsive therapy and Antidepressant
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 68 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2017to 31 Dec 2021
- How long will I take part?
- 6 Months
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Depressive patients from a primary care clinic
Who may be able to join
- current diagnosis of Major Depression
- severity of current symptoms on a clinical level as indicated by scores of the Hamilton Scale of Depression
- age 25 to 60 in order to exclude cases of late-onset depression and age- associated changes in brain functions and volume
- right handedness
- fluency in spoken and written German
- treatment resistant depression, i.e. at least with two failed antidepressant treatment trials as assessed with the Antidepressant Treatment History Form (ATHF)
Who cannot join
- history of psychosis or mania, current eating disorder, obsessive- compulsive disorder (OCD), current self-harm, current substance abuse or dependence
- history of traumatic brain injury
- current treatment with glutamate- modulating medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Electroconvulsive Therapy on Neuronal, Immunological and Hormonal Parameters in Patients With Affective Disorders
The project aims to investigate markers of neural activity and connectivity, neurochemistry, hypothalamic-pituitary-adrenal (HPA) axis activity, inflammation and neuronal plasticity underlying treatment response and remission after ECT. These measures will be assessed in depressive patients prior, during and after ECT and also after 6 months. Furthermore, we will investigate a control group of depressive patients treated with antidepressants.
Read the detailed description
About 30% of patients suffering from major depressive disorder (MDD) do not respond sufficiently to established pharmacological, psychotherapeutic, or somatic treatment. Treatment-resistant MDD is associated with illness chronicity, a reduced quality of life, and a higher risk for suicide. For these patients, electroconvulsive therapy (ECT) is a well-established treatment strategy with response rates of 60% to 80%, making it the most potent and rapidly acting treatment for MDD. Despite the frequent and widespread use of ECT for more than 70 years, the exact neurobiological mechanisms underlying its efficacy remain unclear. In a broader sense, understanding the therapeutic effects of ECT may also shed some more light on the pathophysiological causes of severe depression and the mechanisms of action of an effective treatment. Eventually, the elucidation of the effects of ECT could allow for their reproduction in a less invasive way and with a more benign side-effect profile, thereby resulting in an significantly enhanced treatment of MDD. To achieve this, though, we need first to understand better how ECT influences brain function. The proposed project therefore aims to investigate markers of neural activity and connectivity, neurochemistry, HPA axis activity, inflammation and neuronal plasticity underlying treatment response and remission after ECT. These measures will be assessed in depressive patients prior, during and after ECT and also after 6 months. Furthermore, we will investigate a control group of depressive patients treated with antidepressants. This treatment-specific approach will enable us to disentangle which behavioral, neuronal, hormonal and immunological alterations are crucial for an antidepressant response and might be used for response prediction. More generally, the project will greatly broaden our understanding of the mechanisms underlying the profound antidepressant effect of ECT and thereby shed some more light on the pathophysiological causes of MDD and the mechanisms of action of an effective treatment.
- Conditions
- Major Depressive Disorder
- Being tested
- electroconvulsive therapy, Antidepressant
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroconvulsive therapyProcedure or surgery
electroconvulsive therapy
AntidepressantDrug
Antidepressant
| Study group | Role | What they receive |
|---|---|---|
| ECT group | Patients with a major depressive episode treated with ECT. Patients will be investigated (i) prior to the 1st ECT session, (ii) after the 4th ECT session, (iii) after the 12th ECT session, and (iv) 6 months after the 1st ECT session. Receives: Procedure: electroconvulsive therapy | |
| Antidepressant group | Patients with a major depressive episode treated with antidepressants. Patients will be investigated (i) prior to treatment, (ii) after 10 days of treatment, (iii) after 4 weeks of treatment, and (iv) after 6 months. Receives: Drug: Antidepressant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in functional connectivity between medial and lateral prefrontal regions
Patients in the ECT group will be investigated (i) prior to the 1st ECT session, (ii) after the 4th ECT session, (iii) after the 12th ECT session, and (iv) 6 months after the 1st ECT session. Patients in the antidepressant group will be investigated (i) prior to treatment, (ii) after 10 days of treatment, (iii) after 4 weeks of treatment, and (iv) after 6 months. Measurements will be conducted using functional magnetic resonance imaging.
Measured: 4 timepoints (ECT group: prior to 1st ECT, after the 4th ECT, after the 12th ECT, after 6 months; antidepressant group: prior to treatment, after 10 days, after 4 weeks , after 6 months
Changes in functional activity in medial and lateral prefrontal regions
Patients in the ECT group will be investigated (i) prior to the 1st ECT session, (ii) after the 4th ECT session, (iii) after the 12th ECT session, and (iv) 6 months after the 1st ECT session. Patients in the antidepressant group will be investigated (i) prior to treatment, (ii) after 10 days of treatment, (iii) after 4 weeks of treatment, and (iv) after 6 months. Measurements will be conducted using functional magnetic resonance imaging.
Measured: 4 timepoints (ECT group: prior to 1st ECT, after the 4th ECT, after the 12th ECT, after 6 months; antidepressant group: prior to treatment, after 10 days, after 4 weeks , after 6 months
Changes in neurotransmitter concentrations in medial and lateral prefrontal regions
Patients in the ECT group will be investigated (i) prior to the 1st ECT session, (ii) after the 4th ECT session, (iii) after the 12th ECT session, and (iv) 6 months after the 1st ECT session. Patients in the antidepressant group will be investigated (i) prior to treatment, (ii) after 10 days of treatment, (iii) after 4 weeks of treatment, and (iv) after 6 months. Measurements will be conducted using functional magnetic resonance spectroscopy.
Measured: 4 timepoints (ECT group: prior to 1st ECT, after the 4th ECT, after the 12th ECT, after 6 months; antidepressant group: prior to treatment, after 10 days, after 4 weeks , after 6 months
Changes in levels of cytokines, cortisol and BDNF
Patients in the ECT group will be investigated (i) prior to the 1st ECT session, (ii) after the 4th ECT session, (iii) after the 12th ECT session, and (iv) 6 months after the 1st ECT session. Patients in the antidepressant group will be investigated (i) prior to treatment, (ii) after 10 days of treatment, (iii) after 4 weeks of treatment, and (iv) after 6 months. Serum (BDNF, cytokines) and plasma (cortisol) levels will be obtained.
Measured: 4 timepoints (ECT group: prior to 1st ECT, after the 4th ECT, after the 12th ECT, after 6 months; antidepressant group: prior to treatment, after 10 days, after 4 weeks , after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study start1 Sep 2017
- Primary completion31 May 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- 68 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Grimm, Charite University, Berlin, Germany
- Investigators
- Malek Bajbouj, MD, Principal investigator, Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871141
- Sponsor's protocol ID
- BA 3578_ECT
- Status last verified
- Oct 2022
- First submitted
- 9 Aug 2016
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gruzman R, Hempel M, Domke AK, Hartling C, Stippl A, Carstens L, Bajbouj M, Gartner M, Grimm S. Investigating the impact of rumination and adverse childhood experiences on resting-state neural activity and connectivity in depression. J Affect Disord. 2024 Aug 1;358:283-291. doi: 10.1016/j.jad.2024.02.068. Epub 2024 Feb 20.
PubMed 38387672
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Electroconvulsive Therapy on Neuronal, Immunological and Hormonal Parameters in Patients With Affective Disorders
- ClinicalTrials.gov ID
- NCT02871141
- Acronym / sponsor ID
- BA 3578_ECT
- Conditions
- Major Depressive Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 18 Aug 2016 (estimated)
- 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 project aims to investigate markers of neural activity and connectivity, neurochemistry, hypothalamic-pituitary-adrenal (HPA) axis activity, inflammation and neuronal plasticity underlying treatment response and remission after ECT. These measures will be assessed in depressive patients prior, during and after ECT and also after 6 months. Furthermore, we will investigate a control group of depressive patients treated with antidepressants.
Detailed description
About 30% of patients suffering from major depressive disorder (MDD) do not respond sufficiently to established pharmacological, psychotherapeutic, or somatic treatment. Treatment-resistant MDD is associated with illness chronicity, a reduced quality of life, and a higher risk for suicide. For these patients, electroconvulsive therapy (ECT) is a well-established treatment strategy with response rates of 60% to 80%, making it the most potent and rapidly acting treatment for MDD. Despite the frequent and widespread use of ECT for more than 70 years, the exact neurobiological mechanisms underlying its efficacy remain unclear. In a broader sense, understanding the therapeutic effects of ECT may also shed some more light on the pathophysiological causes of severe depression and the mechanisms of action of an effective treatment. Eventually, the elucidation of the effects of ECT could allow for their reproduction in a less invasive way and with a more benign side-effect profile, thereby resulting in an significantly enhanced treatment of MDD. To achieve this, though, we need first to understand better how ECT influences brain function. The proposed project therefore aims to investigate markers of neural activity and connectivity, neurochemistry, HPA axis activity, inflammation and neuronal plasticity underlying treatment response and remission after ECT. These measures will be assessed in depressive patients prior, during and after ECT and also after 6 months. Furthermore, we will investigate a control group of depressive patients treated with antidepressants. This treatment-specific approach will enable us to disentangle which behavioral, neuronal, hormonal and immunological alterations are crucial for an antidepressant response and might be used for response prediction. More generally, the project will greatly broaden our understanding of the mechanisms underlying the profound antidepressant effect of ECT and thereby shed some more light on the pathophysiological causes of MDD and the mechanisms of action of an effective treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECT group | – | Procedure: electroconvulsive therapyPatients with a major depressive episode treated with ECT. Patients will be investigated (i) prior to the 1st ECT session, (ii) after the 4th ECT session, (iii) after the 12th ECT session, and (iv) 6 months after the 1st ECT session. |
| Antidepressant group | – | Drug: AntidepressantPatients with a major depressive episode treated with antidepressants. Patients will be investigated (i) prior to treatment, (ii) after 10 days of treatment, (iii) after 4 weeks of treatment, and (iv) after 6 months. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Depressive patients from a primary care clinic
Key inclusion criteria (6 listed)
- current diagnosis of Major Depression
- severity of current symptoms on a clinical level as indicated by scores of the Hamilton Scale of Depression
- age 25 to 60 in order to exclude cases of late-onset depression and age- associated changes in brain functions and volume
- right handedness
- fluency in spoken and written German
Key exclusion criteria (3 listed)
- history of psychosis or mania, current eating disorder, obsessive- compulsive disorder (OCD), current self-harm, current substance abuse or dependence
- history of traumatic brain injury
- current treatment with glutamate- modulating medication.
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 |
|---|---|---|
| electroconvulsive therapyelectroconvulsive therapy | Procedure or surgery | ECT group |
| AntidepressantAntidepressant | Drug | Antidepressant group |
Primary outcome
Changes in functional connectivity between medial and lateral prefrontal regions
Time frame: 4 timepoints (ECT group: prior to 1st ECT, after the 4th ECT, after the 12th ECT, after 6 months; antidepressant group: prior to treatment, after 10 days, after 4 weeks , after 6 months
Patients in the ECT group will be investigated (i) prior to the 1st ECT session, (ii) after the 4th ECT session, (iii) after the 12th ECT session, and (iv) 6 months after the 1st ECT session. Patients in the antidepressant group will be investigated (i) prior to treatment, (ii) after 10 days of treatment, (iii) after 4 weeks of treatment, and (iv) after 6 months. Measurements will be conducted using functional magnetic resonance imaging.
Changes in functional activity in medial and lateral prefrontal regions
Time frame: 4 timepoints (ECT group: prior to 1st ECT, after the 4th ECT, after the 12th ECT, after 6 months; antidepressant group: prior to treatment, after 10 days, after 4 weeks , after 6 months
Patients in the ECT group will be investigated (i) prior to the 1st ECT session, (ii) after the 4th ECT session, (iii) after the 12th ECT session, and (iv) 6 months after the 1st ECT session. Patients in the antidepressant group will be investigated (i) prior to treatment, (ii) after 10 days of treatment, (iii) after 4 weeks of treatment, and (iv) after 6 months. Measurements will be conducted using functional magnetic resonance imaging.
Changes in neurotransmitter concentrations in medial and lateral prefrontal regions
Time frame: 4 timepoints (ECT group: prior to 1st ECT, after the 4th ECT, after the 12th ECT, after 6 months; antidepressant group: prior to treatment, after 10 days, after 4 weeks , after 6 months
Patients in the ECT group will be investigated (i) prior to the 1st ECT session, (ii) after the 4th ECT session, (iii) after the 12th ECT session, and (iv) 6 months after the 1st ECT session. Patients in the antidepressant group will be investigated (i) prior to treatment, (ii) after 10 days of treatment, (iii) after 4 weeks of treatment, and (iv) after 6 months. Measurements will be conducted using functional magnetic resonance spectroscopy.
Changes in levels of cytokines, cortisol and BDNF
Time frame: 4 timepoints (ECT group: prior to 1st ECT, after the 4th ECT, after the 12th ECT, after 6 months; antidepressant group: prior to treatment, after 10 days, after 4 weeks , after 6 months
Patients in the ECT group will be investigated (i) prior to the 1st ECT session, (ii) after the 4th ECT session, (iii) after the 12th ECT session, and (iv) 6 months after the 1st ECT session. Patients in the antidepressant group will be investigated (i) prior to treatment, (ii) after 10 days of treatment, (iii) after 4 weeks of treatment, and (iv) after 6 months. Serum (BDNF, cytokines) and plasma (cortisol) levels will be obtained.
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 1 Nov 2022.
- Derived from this study: PubMed 38387672Gruzman R, Hempel M, Domke AK, Hartling C, Stippl A, Carstens L, Bajbouj M, Gartner M, Grimm S. Investigating the impact of rumination and adverse childhood experiences on resting-state neural activity and connectivity in depression. J Affect Disord. 2024 Aug 1;358:283-291. doi: 10.1016/j.jad.2024.02.068. Epub 2024 Feb 20.
- Individual participant dataSharing planned: No
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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.
Malek Bajbouj, MD principal investigator
Charité
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Charite University, Berlin, Germany at 1 site in Germany.
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 6 inclusion and 3 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 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Changes in functional connectivity between medial and lateral prefrontal regions (time frame: 4 timepoints (ECT group: prior to 1st ECT, after the 4th ECT, after the 12th ECT, after 6 months; antidepressant group: prior to treatment, after 10 days, after 4 weeks , after 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02871141, which also lists 1 linked publication.
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 1 Nov 2022.