Amplitude Titration to Improve ECT Clinical Outcomes

Part of paid clinical trials in Albuquerque, New Mexico.

Sponsor
University of New Mexico
Study ID
NCT05699226
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Soterix Medical Incorporated 4x1 adapter — DEVICE
    Device permits individualized amplitudes
  • Traditional ECT device — DEVICE
    FDA approved ECT device with fixed amplitude.

Study Details

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

Key Dates

Start date
Sep 14, 2023
Status verified
Jan 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Variable amplitude
    Individualized amplitude
  • Active Comparator: Fixed amplitude
    Fixed (800 milliamperes) amplitude

Primary Outcome Measure

Inventory of Depressive Symptomatology - Clinician Rated [ Time Frame: 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of New Mexico Health Science CenterAlbuquerqueNew Mexico87110
Chris Abbott, MD
[email protected]
505-272-2223

Find similar trials in Albuquerque, NM

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
University of New Mexico Health Science Center· Albuquerque, NM

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