Ecological momentary assessment and (epi-) genetics in patients treated with electroconvulsive therapy

Ecological momentary assessment and (epi-) genetics in patients treated with electroconvulsive therapy - EMAGenE

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00021190

Enrollment

100

Registered

2020-03-30

Start date

2020-11-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F20-F29 F30-F39

Interventions

Group 1: Patients do not receive ECT treatment as part of the study, but as part of their therapy program, which is why they are in the clinic. It is an observational study in which the following inv

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: The patients must have been diagnosed with one of the following diseases: - delusional depression, or severe depressive episode with psychotic symptoms (ICD-10: F32.4) - therapy-resistant major depression - schizoaffective disorder with severe depressive mood - refractory schizophrenia In addition, the following inclusion criteria must be met: - Ability to give consent or the consent of an authorised representative or guardian - Legal age of majority

Exclusion criteria

Exclusion criteria: Exclusion criteria for the study is - Current pregnancy

Design outcomes

Secondary

Measure	Time frame
The secondary endpoint is the Hamilton Rating Scale for Depression (HAMD) score after the last ECT sessions, i.e. after completion of ECT treatment.	—

Primary

Measure	Time frame
In summary, three main hypotheses will be tested in this study: 1. the two extreme groups ("non-responders" versus very well responding "remitters") differ in their respective gene expression profiles, epigenetics, proteome, microbiome, actimetry, psychometry, as well as functional level and quality of life. 2. the samples from the three measurement timepoints (mainly before ECT, after 6 ECT sessions, and after the last ECT session) differ in the respective gene expression profiles, epigenetics, microbiome, proteome, actimetry, psychometry, as well as functional level and quality of life. 3) From the gene expression profiles, epigenetics, microbiome, proteome, actimetry, psychometry, as well as the functional level and quality of life, new, more reliable and valid predictors for therapy response can be established. Those can be tested on national (e.g. Münster or Göttingen) or international data sets (e.g. GenECT, initiator: Prof. Dr. Bernhard Baune, University of Adelaide). The primary endpoint is the Hamilton Rating Scale for Depression (HAMD) cumulative score after the first six ECT sessions.	—

Measure

Time frame

In summary, three main hypotheses will be tested in this study: 1. the two extreme groups ("non-responders" versus very well responding "remitters") differ in their respective gene expression profiles, epigenetics, proteome, microbiome, actimetry, psychometry, as well as functional level and quality of life. 2. the samples from the three measurement timepoints (mainly before ECT, after 6 ECT sessions, and after the last ECT session) differ in the respective gene expression profiles, epigenetics, microbiome, proteome, actimetry, psychometry, as well as functional level and quality of life. 3) From the gene expression profiles, epigenetics, microbiome, proteome, actimetry, psychometry, as well as the functional level and quality of life, new, more reliable and valid predictors for therapy response can be established. Those can be tested on national (e.g. Münster or Göttingen) or international data sets (e.g. GenECT, initiator: Prof. Dr. Bernhard Baune, University of Adelaide). The primary endpoint is the Hamilton Rating Scale for Depression (HAMD) cumulative score after the first six ECT sessions.

—

Countries

Germany

Contacts

Public ContactLea Sirignano

Zentralinstitut für seelische Gesundheit

lea.sirignano@zi-mannheim.de+ 49 621 1703-6067

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026