Recruiting

Amplitude Titration

Sponsor:

University of New Mexico

Code:

NCT05699226

Conditions

Depression

ECT

Cognitive Change

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Soterix Medical Incorporated 4x1 adapter

Traditional ECT device

Study Details

Brief summary:

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

Conditions

Depression

ECT

Cognitive Change

Study ID

NCT05699226

Start date

Sep 14, 2023

Status verified date

Jan, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Variable amplitude

Individualized amplitude

active comparator: Fixed amplitude

Fixed (800 milliamperes) amplitude

Interventions

Soterix Medical Incorporated 4x1 adapter

Device permits individualized amplitudes

Traditional ECT device

FDA approved ECT device with fixed amplitude.

Primary outcome measure

  • Inventory of Depressive Symptomatology - Clinician Rated [ Time Frame: 4 weeks ]
  • Delis Kaplan Executive Function System Letter Fluency [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Chris Abbott, MD

5052720406cabbott@salud.unm.edu

Megan Lloyd, MS

‭(505) 272-3507‬meglloyd@salud.unm.edu

Locations

University of New Mexico Health Science Center

Recruiting

Albuquerque, New Mexico, United States, 87110

Contacts

Chris Abbott, MD

505-272-2223cabbott@salud.unm.edu

More Information

Sponsor

University of New Mexico

Last update posted

Jan 26, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of New Mexico on 2026-01-26.