Amplitude Titration to Improve ECT Clinical Outcomes

ConditionsDepression ECT Cognitive Change

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age50+

SponsorUniversity of New Mexico

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of major depressive disorder or bipolar II

Clinical indications for ECT with right unilateral electrode placement

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Variable amplitudeExperimental treatment 1 intervention

Group B: Fixed amplitudeActive comparator 1 intervention

Trial outcomes

Primary outcomes

Inventory of Depressive Symptomatology - Clinician Rated

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

Time frame

4 weeks

Delis Kaplan Executive Function System Letter Fluency

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

Time frame

4 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of New Mexico

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov

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