ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depres… (NCT03113968) | Clinical Trial Compass
CompletedPhase 2/3
ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD)
United States403 participantsStarted 2017-04-07
Plain-language summary
The goal of the study is to conduct a comparative randomized trial of electroconvulsive therapy (ECT) vs. ketamine for patients with treatment resistant depression (TRD) in a real world setting with patient reported outcomes as primary and secondary outcome measures.
Who can participate
Age range21 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Written informed consent before any study related procedures are performed
✓. Inpatients or outpatients referred by their providers for ECT treatment and eligible for ECT treatment
✓. Males/females at least 21 years of age but no older than 75 years of age
✓. Meet DSM-5 criteria for Major Depressive Episode as determined by both:
✓. A current depressive episode that has lasted a minimum of 4 weeks
✓. Meet all of the following criteria on symptom rating scales at screening:
✓. Have had ≥2 adequate trials of antidepressants or augmentation strategies during their lifetime. An adequate trial is defined as 4 weeks of medication at the minimum FDA approved dose. This will be equal to a trial rating of 3 or more.
✓. In the opinion of the investigator, the patient is willing and able to comply with scheduled visits, treatment plan, and other trial procedures for the duration of the study
Exclusion criteria
✕. Meet DSM-5 criteria for bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, or pervasive developmental disorder
✕. Meets any exclusion criteria for ECT or ketamine treatment as described in the clinical guidelines or according to investigator judgment
✕. The patient is pregnant or breast feeding
What they're measuring
1
Number of Participants With Treatment Responses Based on the 16-item Quick Inventory of Depressive Symptomatology-Self-Report Scale (QIDS-SR-16)
Timeframe: Acute Study Phase (Baseline Visit to End of Treatment Visit) - approximately 3-5 weeks