RecruitingNot ApplicableNCT05699226

Amplitude Titration to Improve ECT Clinical Outcomes

Amplitude Titration to Improve ECT Clinical Outcomes Randomized Clinical Trial


Sponsor

University of New Mexico

Enrollment

50 participants

Start Date

Sep 14, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 50 Years

Inclusion Criteria2

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

Exclusion Criteria4

  • 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.

Interventions

DEVICESoterix Medical Incorporated 4x1 adapter

Device permits individualized amplitudes

DEVICETraditional ECT device

FDA approved ECT device with fixed amplitude.


Locations(1)

University of New Mexico Health Science Center

Albuquerque, New Mexico, United States

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NCT05699226


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