ECT Pulse Amplitude and Medial Temporal Lobe Engagement

NCT02999269 | Completed Phase 4 Results DMC FDA Device

• 1 other identifier: 5U01MH111826
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Electroconvulsive therapy (ECT) remains the gold-standard treatment for patients with depressive episodes. During a typical four-week ECT series, most depressive episodes will respond to treatment and people will improve their level of functioning (return to work or family). Independent of the antidepressant effect of ECT, many patients experience transient memory impairment. This investigation will examine the impact of one ECT parameter (pulse amplitude or current) on brain changes (structure of connections within the brain) and clinical outcomes. The goal of this investigation is to determine the optimal parameter for an individual patient that will maintain the clinical response (reduce depression severity) and minimize side effects (eliminate memory issues related to treatment).

Conditions

Major Depressive Disorder

Keywords

electroconvulsive therapy; MRI; major depressive disorder

Outcome Measures

Primary Outcomes (2)

• Depression Severity

  Hamilton Depression Rating Scale - 24 item. Scores range from 0 to 76 (higher scores indicate more depression severity)

  post-ECT Hamilton Depression Rating Scale -24 item. The time frame is 4 weeks after study initiation.

• Cognition

  Hopkins Verbal Learning Trial-Revised (percent retention score, range 0 - 100, higher is better)

  post-ECT Hopkins Verbal Learning Trial-Revised (percent retention score, range 0 - 100, higher is better). The time frame is 4 weeks after study initiation.

Study Arms (3)

600 mA Right Unilateral ECT

EXPERIMENTAL

MECTA Spectrum 5000Q Amplitude

Device: MECTA Spectrum 5000Q Amplitude

700 mA Right Unilateral ECT

EXPERIMENTAL

MECTA Spectrum 5000Q Amplitude

Device: MECTA Spectrum 5000Q Amplitude

800 mA Right Unilateral ECT

ACTIVE COMPARATOR

MECTA Spectrum 5000Q Amplitude

Device: MECTA Spectrum 5000Q Amplitude

Interventions

MECTA Spectrum 5000Q Amplitude DEVICE

Current

600 mA Right Unilateral ECT; 700 mA Right Unilateral ECT; 800 mA Right Unilateral ECT

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of major depressive disorder (with or without psychotic features)
• the clinical indications for ECT including treatment resistance or a need for a rapid and definitive response
• Hamilton Depression Rating Scale 24-item (HDRS-24) \> 21
• age range between 50 and 80 years of age
• right-handedness

You may not qualify if:

• Defined neurological or neurodegenerative disorder (e.g., history of head injury with loss of consciousness \> 5 minutes, epilepsy, Alzheimer's disease)
• other psychiatric conditions (e.g., schizophrenia, schizoaffective disorder, bipolar disorder)
• current drug or alcohol use disorder, except for nicotine; and 4) contraindications to MRI.

Sponsors & Collaborators

• University of New Mexico: lead
• The Mind Research Network: collaborator
• University of Texas: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Chris Abbott

Albuquerque, New Mexico, 87131-0001, United States

Location

Related Publications (2)

• Abbott CC, Quinn D, Miller J, Ye E, Iqbal S, Lloyd M, Jones TR, Upston J, Deng Z, Erhardt E, McClintock SM. Electroconvulsive Therapy Pulse Amplitude and Clinical Outcomes. Am J Geriatr Psychiatry. 2021 Feb;29(2):166-178. doi: 10.1016/j.jagp.2020.06.008. Epub 2020 Jun 17.

  PMID: 32651051 RESULT

• Qi S, Calhoun VD, Zhang D, Miller J, Deng ZD, Narr KL, Sheline Y, McClintock SM, Jiang R, Yang X, Upston J, Jones T, Sui J, Abbott CC. Links between electroconvulsive therapy responsive and cognitive impairment multimodal brain networks in late-life major depressive disorder. BMC Med. 2022 Dec 8;20(1):477. doi: 10.1186/s12916-022-02678-6.

  PMID: 36482369 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Limitations and Caveats

Subjects discontinued scheduled antidepressant and antipsychotic medications prior to the first imaging assessment, but as-needed medications (lorazepam, quetiapine, trazodone) were permissible with dose restrictions during the ECT series. Second, our study design included a change in pulse width (from 0.3 to 1.0 ms). Each amplitude arm had a very limited number of subjects with brief pulse width. The relationship between amplitude and pulse width will require more research.

Results Point of Contact

• Title: Dr. Chris Abbott, Division Chief Neuromodulaton, Department of Psychiatry
• Organization: University of New Mexico

cabbott@salud.unm.edu

505272223

Study Officials

• Chris Abbott, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double-blind (participant and outcomes assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director ECT Service

Model Details: Subjects randomized to right unilateral ECT with 600, 700, or 800 mA pulse amplitude.

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: December 21, 2016
• Study Start: October 1, 2016
• Primary Completion: March 23, 2020
• Study Completion: March 23, 2020
• Last Updated: July 24, 2023
• Results First Posted: July 24, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Clinical, cognitive and MRI data was uploaded to NDA.
• Access Criteria: per NDA protocol

Locations

US (1)