- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02871141
Multimodal Imaging of ECT Effects
October 31, 2022 updated by: Simone Grimm, Charite University, Berlin, Germany
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
68
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Berlin, Germany, 12200
- Charité
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Depressive patients from a primary care clinic
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
Antidepressant
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
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
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.
|
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
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.
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Malek Bajbouj, MD, Charité
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2017
Primary Completion (Actual)
May 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
August 9, 2016
First Submitted That Met QC Criteria
August 17, 2016
First Posted (Estimate)
August 18, 2016
Study Record Updates
Last Update Posted (Actual)
November 1, 2022
Last Update Submitted That Met QC Criteria
October 31, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BA 3578_ECT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Major Depressive Disorder
-
York UniversityCentre for Addiction and Mental HealthSuspendedDisorder, Major DepressiveCanada
-
Shalvata Mental Health CenterUnknownMAjor Depressive DisorderIsrael
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDD)India
-
Repurposed Therapeutics, Inc.Unknown
-
GlaxoSmithKlineCompletedMajor Depressive Disorder (MDD)United States
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDDIndia
-
Gangnam Severance HospitalCompletedMajor Depressive Disorder(MDD)Korea, Republic of
-
University College, LondonCompletedUnipolar Major Depressive DisorderUnited Kingdom
-
Fundació Institut de Recerca de l'Hospital de la...Fondo de Investigacion SanitariaUnknown
-
AccexibleRecruitingMajor Depressive Disorder (MDD)Spain
Clinical Trials on electroconvulsive therapy
-
Medical University of LodzUnknown
-
Haukeland University HospitalHelse Stavanger HFRecruiting
-
Charles University, Czech RepublicRecruitingBipolar Depression | Major Depressive DisorderCzechia
-
Mehmet Diyaddin GülekenUnknown
-
University of Medicine and Dentistry of New JerseyNational Institute of Mental Health (NIMH)CompletedComparison of Three Electroconvulsive Therapy (ECT) Techniques for the Treatment of Major DepressionDepressionUnited States
-
Massachusetts General HospitalRecruitingBipolar Depression | Unipolar DepressionUnited States
-
Haukeland University HospitalUniversity of BergenCompletedDepression | Electroconvulsive Therapy
-
Haukeland University HospitalUniversity of BergenRecruitingHealthy | Major Depressive Disorder | Major Depressive Disorder 1Norway
-
Shanghai Mental Health CenterCompleted
-
Eastern Virginia Medical SchoolSentara Norfolk General HospitalTerminatedSelf-Injurious Behavior | Autism Spectrum DisorderUnited States