Amplitude Titration to Improve ECT Clinical Outcomes
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
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
Treatments tested in this trial
- Soterix Medical Incorporated 4x1 adapter
- Traditional ECT device
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of New Mexico
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov