Phase 4
N=60
ECT Pulse Amplitude and Medial Temporal Lobe Engagement
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02999269 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Depression Severity — 22.5; 12.0; 14.1 score on a scale — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- MECTA Spectrum 5000Q Amplitude (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of New Mexico
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depression Severity |
22.5; 12.0; 14.1 | 0.04 sig |
| PRIMARY Cognition |
57.3; 68; 62 | 0.37 |
Summary
Electroconvulsive therapy (ECT) remains the gold-standard treatment for patients with depressive episodes. During a typical four-week ECT series, most depressive episodes will respond to treatment and people will improve their level of functioning (return to work or family). Independent of the antidepressant effect of ECT, many patients experience transient memory impairment. This investigation will examine the impact of one ECT parameter (pulse amplitude or current) on brain changes (structure of connections within the brain) and clinical outcomes. The goal of this investigation is to determine the optimal parameter for an individual patient that will maintain the clinical response (reduce depression severity) and minimize side effects (eliminate memory issues related to treatment).
Eligibility Criteria
Inclusion Criteria
- Diagnosis of major depressive disorder (with or without psychotic features)
- the clinical indications for ECT including treatment resistance or a need for a rapid and definitive response
- Hamilton Depression Rating Scale 24-item (HDRS-24) > 21
- age range between 50 and 80 years of age
- right-handedness
Exclusion Criteria
- Defined neurological or neurodegenerative disorder (e.g., history of head injury with loss of consciousness > 5 minutes, epilepsy, Alzheimer's disease)
- other psychiatric conditions (e.g., schizophrenia, schizoaffective disorder, bipolar disorder)
- current drug or alcohol use disorder, except for nicotine; and 4) contraindications to MRI.
Data sourced from ClinicalTrials.gov (NCT02999269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.