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Amplitude Titration to Improve ECT Clinical Outcomes

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

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ClinicalTrials.gov IDNCT05699226

PhaseNA

Enrollment50

SponsorUniversity of New Mexico

Age50 Years and older

SexALL

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Conditions studied

Depression, ECT, Cognitive Change

About this study

Interventions

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

Primary outcomes

Inventory of Depressive Symptomatology - Clinician Rated (4 weeks)
Delis Kaplan Executive Function System Letter Fluency (4 weeks)

Eligibility information

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 locations

University of New Mexico Health Science Center, Albuquerque, New Mexico 87110 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.