Predicting how well electroconvulsive therapy works for depression
Prediction of Antidepressant Effects of Electroconvulsive Therapy
Medical University of Vienna · NCT05630469
This study is trying to see if changes in the brain can help predict how well electroconvulsive therapy will work for people with major depression.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Medical University of Vienna (other) |
| Locations | 1 site (Vienna) |
| Trial ID | NCT05630469 on ClinicalTrials.gov |
What this trial studies
This observational study aims to understand the effects of electroconvulsive therapy (ECT) on patients with major depressive disorder by examining changes in brain structure and function through advanced neuroimaging techniques. Over a period of 36 months, 30 eligible patients will undergo two MRI scans, one before and one after a course of ECT, alongside blood and cerebrospinal fluid sampling. The goal is to identify objective biomarkers that can predict the response to ECT, which has been used for decades but lacks clear predictive markers in clinical practice.
Who should consider this trial
Good fit: Ideal candidates are inpatients aged 18-65 with severe unipolar depression who are eligible for ECT.
Not a fit: Patients with severe somatic or neurological diseases, current comorbid psychiatric disorders, or substance dependence may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment options for patients suffering from severe depression.
How similar studies have performed: While ECT has been widely used, this approach to identifying predictive biomarkers through neuroimaging is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * male or female inpatients (18-65 years old) * ICD-10 diagnosis of severe unipolar depression (F32.2, F32.3, F33.2, F33.3) * HAMD17 ≥ 23 * physical health * ability to understand and willingness to sign the written informed consent document * negative drug screening, negative urine pregnancy test in women * antidepressant and antipsychotic medication in steady state for at least 10 days prior inclusion * anesthesiological approval for ECT Excusion criteria: * severe somatic or neurological disease * current comorbid psychiatric disorder, including bipolar depression (according to DSM-5) * current or past history of schizophrenia or schizoaffective disorder * current use of alcohol, drugs of abuse, or any medication in a manner which is indicative of chronic abuse or who meet DSM-5 criteria for alcohol or other substance dependence * clinically relevant abnormalities on a general physical examination and routine laboratory screening * pregnancy, breast feeding * contraindications to lumbar puncture (increased intracranial volume, anticoagulant medication, uncorrected bleeding diathesis, coagulopathy, congenital spine abnormality, recent spinal trauma/surgery, skin infection at puncture site) * any implant or stainless steel graft contraindicated for MRI
Where this trial is running
Vienna
- Department of Psychiatry and Psychotherapy, Medical University of Vienna — Vienna, Austria (RECRUITING)
Study contacts
- Study coordinator: Pia Baldinger-Melich, MD, PhD, PD, Assoc.Prof.
- Email: pia.baldinger-melich@meduniwien.ac.at
- Phone: +43 1 40400 35350
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Depressive Disorder, Major, electroconvulsive therapy, neuroimaging, response prediction, biomarker