Multimodal Imaging of ECT Effects

NCT ID: NCT02871141

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 68 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2021-12-31

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Intervention Type: 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.

Antidepressant

Intervention Type: DRUG

Antidepressant

Interventions

electroconvulsive therapy

electroconvulsive therapy

Intervention Type: PROCEDURE

Antidepressant

Antidepressant

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Simone Grimm

PD Dr.rer.nat. Simone Grimm

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Malek Bajbouj, MD

Role: PRINCIPAL_INVESTIGATOR

Charité

Locations

Charité

Berlin, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 38387672 (View on PubMed)

Other Identifiers

BA 3578_ECT

Identifier Type: -

Identifier Source: org_study_id