NCT02871141

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 18, 2016

Completed
1 year until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

3.7 years

First QC Date

August 9, 2016

Last Update Submit

October 31, 2022

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    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

Study Arms (2)

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.

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.

Drug: Antidepressant

Interventions

electroconvulsive therapyPROCEDURE

electroconvulsive therapy

ECT group
AntidepressantDRUG

Antidepressant

Antidepressant group

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Depressive patients from a primary care clinic

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité

Berlin, 12200, Germany

Location

Related Publications (1)

  • 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.

    PMID: 38387672DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Electroconvulsive TherapyAntidepressive Agents

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Convulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological TechniquesPsychotropic DrugsCentral Nervous System AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Malek Bajbouj, MD

    Charité

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr.rer.nat. Simone Grimm

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 18, 2016

Study Start

September 1, 2017

Primary Completion

May 31, 2021

Study Completion

December 31, 2021

Last Updated

November 1, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)