Amplitude Titration to Improve ECT Clinical Outcomes

NCT05699226 | Recruiting DMC FDA Device

• 2 other identifiers: R33MH1251265R61MH125126
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Inventory of Depressive Symptomatology - Clinician Rated

  Depression severity, scores from 0 to 84, higher scores indicate more depression severity

  4 weeks

• Delis Kaplan Executive Function System Letter Fluency

  Cognitive measure, scale scores range from 0 to 20, higher scores indicate better cognitive performance

  4 weeks

Study Arms (2)

Variable amplitude

EXPERIMENTAL

Individualized amplitude

Device: Soterix Medical Incorporated 4x1 adapter

Fixed amplitude

ACTIVE COMPARATOR

Fixed (800 milliamperes) amplitude

Device: Traditional ECT device

Interventions

Traditional ECT device DEVICE

FDA approved ECT device with fixed amplitude.

Fixed amplitude

Soterix Medical Incorporated 4x1 adapter DEVICE

Device permits individualized amplitudes

Variable amplitude

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of major depressive disorder or bipolar II
• Clinical indications for ECT with right unilateral electrode placement

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of New Mexico: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of New Mexico Health Science Center

Albuquerque, New Mexico, 87110, United States

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Chris Abbott, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Abbott, MD

CONTACT

5052720406; cabbott@salud.unm.edu

Megan Lloyd, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This investigation will use allocation concealment and masking for subject assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial with two arms: experimental (variable amplitude) and control (fixed amplitude). Participant and outcomes assessor will be masked to assignment.

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 26, 2023
• Study Start: September 14, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will become available after study completion.
• Access Criteria: National Data Archive guidelines.

Locations

US (1)