Amplitude Titration to Improve ECT Clinical Outcomes
Recruiting · NCT05699226 · Interventional (participants receive a specific treatment) · Lead sponsor: University of New Mexico
View the official record on ClinicalTrials.gov →Interventions studied
Soterix Medical Incorporated 4x1 adapterTraditional ECT device
What this trial is about
A randomized controlled trial will compare hippocampal neuroplasticity, antidepressant, and cognitive outcomes between individualized amplitude and fixed 800 mA amplitude ECT in older depressed subjects (n = 25 per group, n = 50 total). Relative to fixed 800 mA ECT: H1: Individualized amplitude arm will have improved RUL antidepressant outcome (IDS-C30 response rates and reduced BT electrode placement switch at V2). H2: Individualized amplitude arm will have improved cognitive outcomes (DKEFS-Verbal Fluency
Who can take part
Age range
50 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Diagnosis of major depressive disorder or bipolar II
- Clinical indications for ECT with right unilateral electrode placement
Exclusion criteria
- Defined neurological or neurodegenerative disorder (e.g., traumatic brain injury, epilepsy, Alzheimer's disease)
- Other psychiatric conditions (e.g., schizophrenia, bipolar I disorder)
- Current drug or alcohol use disorder (except for nicotine)
- Contraindications to MRI.
Where it is running
1 location listed across 1 US state.
- University of New Mexico Health Science Center - Albuquerque, New Mexico, United States