Depressive DisorderDetECTNCT05463562
Multimodal Biomarkers of Electroconvulsive Therapy in Severe and Treatment-resistant Depression
An observational study of Depressive Disorder and Bipolar Disorder, run by Max-Planck-Institute of Psychiatry at 1 site in Germany.
Trial summary
Electroconvulsive therapy (ECT) is a widespread and safe stimulation method that has been used successfully for decades in psychiatric diseases such as severe or therapy-resistant depression. Unfortunately, ECT still has stigmas attached to it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder, Bipolar Disorder
- How many people
- 134 participants
- Where
- 1 siteGermany
- Study dates
- 24 Feb 2022to 23 Feb 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Only persons of legal age who are in inpatient psychiatric treatment at the Max Planck Institute for Psychiatry and have given consent to participate in local biobanking can take part in the present DetECT study.
Who may be able to join
- Age ≥ 18 years (of legal age, legally competent) and desire to participate
- Diagnosis of a depressive episode (also in the case of bipolar affective disorder) or depression according to the ICD-10 or ICD-11 or DSM-4 or DSM-5
- Indication and planned electroconvulsive therapy
- Signed Electroconvulsive Therapy Informed Consent Form
- Consent to participate by personally signing the declaration of consent including data protection concept and data use for the DetECT study
- Consent and participation in MPI of Psychiatry's biobanking
Who cannot join
- Age < 18 years (minor)
- Pregnancy and breastfeeding
- Existence of legal supervision
- Pervasive developmental disorders and/or intellectual disability
- Acute, relevant substance abuse of alcohol, over-the-counter and prescription drugs, or illicit drugs
- Severe neurological disease (especially severe organic brain damage)
- Acute, serious general illness (especially clinically relevant, aplastic and/or anemia requiring transfusion)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Max Planck Institute of Psychiatry
Munich, Bavaria, 80804
Julius Pape, MD, PhD, 0049-89-30622 ext. 0, detect@psych.mpg.de
Iven von Mücke-Heim, MD, MSc, 0049-89-30622 ext. 0, detect@psych.mpg.de
About this study
Official title: Detection of Multimodal Biomarkers of Electroconvulsive Therapie in Severe and Treatment-resistent Depression
Electroconvulsive therapy (ECT) is a widespread and safe stimulation method that has been used successfully for decades in psychiatric diseases such as severe or therapy-resistant depression. Unfortunately, ECT still has stigmas attached to it. The latter often leads to reservations among those affected and perturbs optimal and guideline-based therapy. Despite the demonstrated effectiveness of ECT, prediction of treatment response is still not possible. This is due to the limited knowledge about the biological mechanisms of action of ECT, especially on an individuum level. Thus, the DetECT study intends to recruit 134 inpatient subjects of the Max Planck Institute of Psychiatry with severe and/or treatment resistant depression receiving ECT to perform weekly psychometry and blood draws before and after ECT sessions one, seven, and twelve. The subsequent biopsychological analysis comprises omics, physiological, neurocognitive, and psychometric measurements. The multimodal data collected will be used to identify data-driven clusters associated with ECT mechanisms and outcome.
Read the detailed description
Background:
With around 320 million cases, depression is one of the most common psychiatric disorders worldwide. In addition to psychopharmacological treatment and psychotherapy, ECT is a common treatment option. This technique is referred to as the gold standard of stimulation procedures due to its good effectiveness and safe application. Despite the widespread use of ECT, knowledge of the underlying biological processes that lead to symptom improvement is still limited. Accordingly, there are no clinical-psychological or biological biomarkers that can reliably predict the course of the disease or the response to ECT in individual cases. Due these circumstances, the primary aim of the present DetECT study is to identify individual parameters or clusters of biological and psychological-clinical features that are associated with the course of depression under ECT.
Material and Methods:
The monocentric, explorative-prospective DetECT study (planned total duration: 3 years) recruits adult and legally competent patients who receive inpatient treatment at the Max Planck Institute for Psychiatry and undergo ECT for a severe depressive episode. Participants will have a total of five (in select cases: seven) venous blood samples taken over an average of seven weeks, that is parallel to the first twelve ECT session on three treatment days (total volume: ~124 ml; in select cases 152 ml). All participants will also be asked to complete self-rating questionnaires on their depressive and neurocognitive symptoms (Patient Health Questionnaire 9 and 15, Questionnaire on Mental Capacity, Beck Depression Inventory II) each week. At the beginning, in the middle and at the end of the seven-week study period, three external assessment questionnaires (Montgomery-Åsberg Depression Rating Scale, Hamilton Rating Scale for Depression, Global Assessment of Functioning) are collected by the study staff. In addition, medical, anamnestic and sociodemographic information on the course of illness and therapy is extracted from the patient records. All biomaterials and data collected in the DetECT study, together with the samples and data from the Max Planck of Psychiatry's biobanking, are double pseudonymised or anonymised and stored for 10 or 30 years, depending on subject preference. Protecting the privacy and rights of the study participants is our top priority. All analyses are performed only by using the participant's study code to guarantee a maximum of data security. Modern and multidimensional analysis techniques will be employed to the biopsychological parameters and to the clinical and socioeconomic information. On a group or subgroup level, this will likely help to link multidimensional biomarker clusters with treatment outcome under ECT.
Discussion:
Taken together, the DetECT study aims to improve the quality of psychiatric treatment of severely depressed patients. The investigators argue that the study novelty lies in its longitudinal and multimodal data collection and analysis approach. This could effectively advance personalization and specification of ECT indication and application. Ultimately as well as in a nutshell, the overall study objective is to identify those patients who benefit most from in terms of the effect/side-effect profile.
- Conditions
- Depressive Disorder, Bipolar Disorder
- Keywords
- electroconvulsive therapy, biomarkers, genetics, depression, prediction, molecular neuroscience
- Medical subject headings
- Depressive Disorder, Bipolar Disorder, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetics
Genotyping based on material extracted from peripheral blood
Measured: baseline
Changes in gene expression over time
Longitudinal analysis of mRNA extracted from peripheral blood
Measured: baseline, week 4, week 7
Changes in epigenetics including gene methylation and miRNA expression over time
Longitudinal analysis of DNA methylation and miRNA expression from peripheral blood
Measured: baseline, week 4, week 7
Protein, lipid, and electrolyte changes over time
Longitudinal analysis of blood-based proteins (e.g. CRP, IL6), lipids (e.g. cholesterol), electrolytes, and other molecules from peripheral blood
Measured: baseline, week 4, week 7
Changes in immunophenotyping over time
Longitudinal phenotyping of different immune cell populations from peripheral blood mononuclear cells (PBMCs)
Measured: baseline, week 4, week 7
Changes in purinergic signalling over time
Longitudinal measurement of purines and pyrimidines as well as their metabolites in peripheral blood
Measured: baseline, week 4, week 7
Changes in body mass index (BMI) over time
Longitudinal analysis of body mass index (BMI)
Measured: baseline, week 4, week 7
Changes in blood pressure over time
Longitudinal analysis of blood pressure
Measured: baseline, week 4, week 7
Clinical and socioeconomic factors
Influence on treatment response
Measured: baseline
Change from baseline in the Hamilton Depression Rating Scale (HAM-D)
The HAM-D measures the presence and severity of depression. Each of the items is rated by a study clinician or trained study staff member and added up to a summary score. Treatment response is generally defined by 50% score reduction, while remission is commonly assumed if the HAM-D score is ≤ 7 points
Measured: Baseline, week 4, and week 7
Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS)
The MADRS measures the presence and severity of depression. Each of the terms is rated by a study clinician or trained study staff member and added up to a summary score. Treatment response is generally defined by 50% score reduction, while remission is commonly assumed if the MADRS score falls short of 12 points
Measured: Baseline, week 4, and week 7
Change from baseline in the Global Assessment of Functioning (GAF)
The GAF approximates the level of symptom burden and psychosocial as well as occupational functioning in daily life. It is tailored primarily to psychiatric patients. It is rated from 0 to 100 by a trained clinician. The GAF score is a continuous variable and allows to estimate symptom reduction and functional assessment from a foreign rater perspective
Measured: Baseline, week 4, and week 7
Change from baseline in the Beck-Depression-Inventory II (BDI-II)
The BDI-II measures the presence and severity of depression symptoms on a mostly psychological and partially somatic level. Each of the 21 items is rated by the patient and added up to a summary score. Treatment response is generally defined by 50% score reduction, while remission is commonly assumed if the BDI-II score is ≤ 10 points
Measured: weekly
Change from baseline in the Patient Health Questionnaire 9 (PHQ-9)
The PHQ-9 is a brief measure of depression symptoms. Each of the 9 items is rated by the patient from 0 = not at all to 3 = nearly every day and added up to a summary score. Treatment response is generally defined by 50% score reduction, while remission is commonly assumed if the PHQ-9 score is ≤ 5 points.
Measured: weekly
Change from baseline in the Patient Health Questionnaire 15 (PHQ-15)
The PHQ-15 is a measure of somatic symptom load in psychiatric disorders. Each of the 15 somatic symptoms is rated by the patient from 0 = not affected to 2 = strongly affected and added up to a summary score. Cut-off values are ≥ 5points (mild), ≥ 10 points (moderate), ≥ 15 points (severe) and represent somatization
Measured: weekly
Change from baseline in the Questionnaire on Mental Capacity (FLEI = dt. Fragebogen zur geistigen Leistungsfähigkeit)
The FLEI measures neurocognitive functioning in the following domains: attention, memory, executive function, control scale. Each of the 35 questions is answered by the patient from 0 = never to 4 = very often. Summary scores are computed for the different neurocognitive domains. Since the FLEI is primarily a continuous variable, symptom reduction is commonly assessed quantitively
Measured: weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start24 Feb 2022
- Primary completion23 Feb 2025 (estimated)
- Study completion23 Feb 2025 (estimated)
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 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Max-Planck-Institute of Psychiatry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth B Binder, MD, PhD, Principal investigator, Max-Planck-Institute of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463562
- Sponsor's protocol ID
- 21-1087
- Acronym
- DetECT
- Status last verified
- Oct 2023
- First submitted
- 11 Jul 2022
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
von Mucke-Heim IA, Pape JC, Grandi NC, Erhardt A, Deussing JM, Binder EB. Multiomics and blood-based biomarkers of electroconvulsive therapy in severe and treatment-resistant depression: study protocol of the DetECT study. Eur Arch Psychiatry Clin Neurosci. 2024 Apr;274(3):673-684. doi: 10.1007/s00406-023-01647-1. Epub 2023 Aug 30.
PubMed 37644215
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Multimodal Biomarkers of Electroconvulsive Therapie in Severe and Treatment-resistent Depression
- ClinicalTrials.gov ID
- NCT05463562
- Acronym / sponsor ID
- DetECT / 21-1087
- Conditions
- Depressive Disorder, Bipolar Disorder
- Keywords
- electroconvulsive therapy, biomarkers, genetics, depression, prediction, molecular neuroscience
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Max-Planck-Institute of PsychiatryUniversity, hospital or other
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 23 Feb 2025 (estimated)
- Study completion
- 23 Feb 2025 (estimated)
- First posted
- 19 Jul 2022 (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.
Electroconvulsive therapy (ECT) is a widespread and safe stimulation method that has been used successfully for decades in psychiatric diseases such as severe or therapy-resistant depression. Unfortunately, ECT still has stigmas attached to it. The latter often leads to reservations among those affected and perturbs optimal and guideline-based therapy. Despite the demonstrated effectiveness of ECT, prediction of treatment response is still not possible. This is due to the limited knowledge about the biological mechanisms of action of ECT, especially on an individuum level. Thus, the DetECT study intends to recruit 134 inpatient subjects of the Max Planck Institute of Psychiatry with severe and/or treatment resistant depression receiving ECT to perform weekly psychometry and blood draws before and after ECT sessions one, seven, and twelve. The subsequent biopsychological analysis comprises omics, physiological, neurocognitive, and psychometric measurements. The multimodal data collected will be used to identify data-driven clusters associated with ECT mechanisms and outcome.
Detailed description
Background:
With around 320 million cases, depression is one of the most common psychiatric disorders worldwide. In addition to psychopharmacological treatment and psychotherapy, ECT is a common treatment option. This technique is referred to as the gold standard of stimulation procedures due to its good effectiveness and safe application. Despite the widespread use of ECT, knowledge of the underlying biological processes that lead to symptom improvement is still limited. Accordingly, there are no clinical-psychological or biological biomarkers that can reliably predict the course of the disease or the response to ECT in individual cases. Due these circumstances, the primary aim of the present DetECT study is to identify individual parameters or clusters of biological and psychological-clinical features that are associated with the course of depression under ECT.
Material and Methods:
The monocentric, explorative-prospective DetECT study (planned total duration: 3 years) recruits adult and legally competent patients who receive inpatient treatment at the Max Planck Institute for Psychiatry and undergo ECT for a severe depressive episode. Participants will have a total of five (in select cases: seven) venous blood samples taken over an average of seven weeks, that is parallel to the first twelve ECT session on three treatment days (total volume: ~124 ml; in select cases 152 ml). All participants will also be asked to complete self-rating questionnaires on their depressive and neurocognitive symptoms (Patient Health Questionnaire 9 and 15, Questionnaire on Mental Capacity, Beck Depression Inventory II) each week. At the beginning, in the middle and at the end of the seven-week study period, three external assessment questionnaires (Montgomery-Åsberg Depression Rating Scale, Hamilton Rating Scale for Depression, Global Assessment of Functioning) are collected by the study staff. In addition, medical, anamnestic and sociodemographic information on the course of illness and therapy is extracted from the patient records. All biomaterials and data collected in the DetECT study, together with the samples and data from the Max Planck of Psychiatry's biobanking, are double pseudonymised or anonymised and stored for 10 or 30 years, depending on subject preference. Protecting the privacy and rights of the study participants is our top priority. All analyses are performed only by using the participant's study code to guarantee a maximum of data security. Modern and multidimensional analysis techniques will be employed to the biopsychological parameters and to the clinical and socioeconomic information. On a group or subgroup level, this will likely help to link multidimensional biomarker clusters with treatment outcome under ECT.
Discussion:
Taken together, the DetECT study aims to improve the quality of psychiatric treatment of severely depressed patients. The investigators argue that the study novelty lies in its longitudinal and multimodal data collection and analysis approach. This could effectively advance personalization and specification of ECT indication and application. Ultimately as well as in a nutshell, the overall study objective is to identify those patients who benefit most from in terms of the effect/side-effect profile.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Only persons of legal age who are in inpatient psychiatric treatment at the Max Planck Institute for Psychiatry and have given consent to participate in local biobanking can take part in the present DetECT study.
Key inclusion criteria (6 listed)
- Age ≥ 18 years (of legal age, legally competent) and desire to participate
- Diagnosis of a depressive episode (also in the case of bipolar affective disorder) or depression according to the ICD-10 or ICD-11 or DSM-4 or DSM-5
- Indication and planned electroconvulsive therapy
- Signed Electroconvulsive Therapy Informed Consent Form
- Consent to participate by personally signing the declaration of consent including data protection concept and data use for the DetECT study
Key exclusion criteria (7 listed)
- Age < 18 years (minor)
- Pregnancy and breastfeeding
- Existence of legal supervision
- Pervasive developmental disorders and/or intellectual disability
- Acute, relevant substance abuse of alcohol, over-the-counter and prescription drugs, or illicit drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genetics
Time frame: baseline
Genotyping based on material extracted from peripheral blood
Changes in gene expression over time
Time frame: baseline, week 4, week 7
Longitudinal analysis of mRNA extracted from peripheral blood
Changes in epigenetics including gene methylation and miRNA expression over time
Time frame: baseline, week 4, week 7
Longitudinal analysis of DNA methylation and miRNA expression from peripheral blood
Protein, lipid, and electrolyte changes over time
Time frame: baseline, week 4, week 7
Longitudinal analysis of blood-based proteins (e.g. CRP, IL6), lipids (e.g. cholesterol), electrolytes, and other molecules from peripheral blood
Changes in immunophenotyping over time
Time frame: baseline, week 4, week 7
Longitudinal phenotyping of different immune cell populations from peripheral blood mononuclear cells (PBMCs)
Changes in purinergic signalling over time
Time frame: baseline, week 4, week 7
Longitudinal measurement of purines and pyrimidines as well as their metabolites in peripheral blood
Changes in body mass index (BMI) over time
Time frame: baseline, week 4, week 7
Longitudinal analysis of body mass index (BMI)
Changes in blood pressure over time
Time frame: baseline, week 4, week 7
Longitudinal analysis of blood pressure
Clinical and socioeconomic factors
Time frame: baseline
Influence on treatment response
Change from baseline in the Hamilton Depression Rating Scale (HAM-D)
Time frame: Baseline, week 4, and week 7
The HAM-D measures the presence and severity of depression. Each of the items is rated by a study clinician or trained study staff member and added up to a summary score. Treatment response is generally defined by 50% score reduction, while remission is commonly assumed if the HAM-D score is ≤ 7 points
Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: Baseline, week 4, and week 7
The MADRS measures the presence and severity of depression. Each of the terms is rated by a study clinician or trained study staff member and added up to a summary score. Treatment response is generally defined by 50% score reduction, while remission is commonly assumed if the MADRS score falls short of 12 points
Change from baseline in the Global Assessment of Functioning (GAF)
Time frame: Baseline, week 4, and week 7
The GAF approximates the level of symptom burden and psychosocial as well as occupational functioning in daily life. It is tailored primarily to psychiatric patients. It is rated from 0 to 100 by a trained clinician. The GAF score is a continuous variable and allows to estimate symptom reduction and functional assessment from a foreign rater perspective
Change from baseline in the Beck-Depression-Inventory II (BDI-II)
Time frame: weekly
The BDI-II measures the presence and severity of depression symptoms on a mostly psychological and partially somatic level. Each of the 21 items is rated by the patient and added up to a summary score. Treatment response is generally defined by 50% score reduction, while remission is commonly assumed if the BDI-II score is ≤ 10 points
Change from baseline in the Patient Health Questionnaire 9 (PHQ-9)
Time frame: weekly
The PHQ-9 is a brief measure of depression symptoms. Each of the 9 items is rated by the patient from 0 = not at all to 3 = nearly every day and added up to a summary score. Treatment response is generally defined by 50% score reduction, while remission is commonly assumed if the PHQ-9 score is ≤ 5 points.
Change from baseline in the Patient Health Questionnaire 15 (PHQ-15)
Time frame: weekly
The PHQ-15 is a measure of somatic symptom load in psychiatric disorders. Each of the 15 somatic symptoms is rated by the patient from 0 = not affected to 2 = strongly affected and added up to a summary score. Cut-off values are ≥ 5points (mild), ≥ 10 points (moderate), ≥ 15 points (severe) and represent somatization
Change from baseline in the Questionnaire on Mental Capacity (FLEI = dt. Fragebogen zur geistigen Leistungsfähigkeit)
Time frame: weekly
The FLEI measures neurocognitive functioning in the following domains: attention, memory, executive function, control scale. Each of the 35 questions is answered by the patient from 0 = never to 4 = very often. Summary scores are computed for the different neurocognitive domains. Since the FLEI is primarily a continuous variable, symptom reduction is commonly assessed quantitively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Derived from this study: PubMed 37644215von Mucke-Heim IA, Pape JC, Grandi NC, Erhardt A, Deussing JM, Binder EB. Multiomics and blood-based biomarkers of electroconvulsive therapy in severe and treatment-resistant depression: study protocol of the DetECT study. Eur Arch Psychiatry Clin Neurosci. 2024 Apr;274(3):673-684. doi: 10.1007/s00406-023-01647-1. Epub 2023 Aug 30.
- 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.
Elisabeth B Binder, MD, PhD principal investigator
Max-Planck-Institute of Psychiatry
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 Depressive Disorder and Bipolar Disorder, run by Max-Planck-Institute of Psychiatry 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 7 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: status not confirmed, as of the sponsor's last update on 19 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julius Pape, MD, PhD (0049-89-30622 ext. 0, detect@psych.mpg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetics (time frame: baseline). The study lists 16 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 NCT05463562, 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 19 Oct 2023.