Major Depressive Disorder Clinical Trial
Official title:
Effects of Electroconvulsive Therapy on Neuronal, Immunological and Hormonal Parameters in Patients With Affective Disorders
Verified date | October 2022 |
Source | Charite University, Berlin, Germany |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 68 |
Est. completion date | December 31, 2021 |
Est. primary completion date | May 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Germany | Charité | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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