NCT02351843

Brief Summary

The purpose of this study is to demonstrate the clinical feasibility of low amplitude electroconvulsive therapy (ECT) to reduce, and possibly eliminate the side effects of ECT by lowering the strength of the ECT stimulus from the conventional 800 mA to 500 mA. Low amplitude ECT could potentially reduce the risks associated with ECT while preserving its unparalleled efficacy. This novel development would remove key obstacles to allow for the wider adoption of ECT as a safe and effective therapy.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

March 22, 2017

Status Verified

August 1, 2016

Enrollment Period

9 months

First QC Date

January 27, 2015

Last Update Submit

March 21, 2017

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • Change in California Verbal Learning Test-II

    Baseline and within 24 to 48 hours of each ECT session

Other Outcomes (7)

  • Change in Hamilton Rating Scale for Depression 24-item

    Baseline and within 24 to 48 hours of each ECT session

  • Change in Quick Inventory of Depressive Symptomatology Clinician Rated and Self Report

    Baseline and within 24 to 48 hours of each ECT session

  • Change in Brief Visuospatial Memory Test-Revised

    Baseline and within 24 to 48 hours of each ECT session

  • +4 more other outcomes

Study Arms (2)

500 mA ECT

EXPERIMENTAL

Right unilateral, ultra brief pulse ECT, with 500 mA current amplitude

Device: MECTA Spectrum 5000Q

800 mA ECT

ACTIVE COMPARATOR

Right unilateral, ultra brief pulse ECT, with 800 mA current amplitude

Device: MECTA Spectrum 5000Q

Interventions

MECTA Spectrum 5000QDEVICE
500 mA ECT800 mA ECT

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female subjects, age 18-70
  • DSM-IV-TR diagnosis of major depressive episode in unipolar or bipolar disorder, confirmed by the MINI-PLUS
  • MMSE total score \> 26
  • Referred for ECT
  • Competent to provide informed consent
  • Able to read or comprehend English

You may not qualify if:

  • Lifetime history of schizophrenia, schizoaffective disorder, mental retardation
  • Current neurostimulation treatment (e.g., ECT, magnetic seizure therapy, transcranial magnetic stimulation, vagus nerve stimulation, deep brain stimulation)
  • Current alcohol abuse or dependence within past 6 months
  • Current substance abuse or dependence within past 6 months
  • History of central nervous system (CNS) disease
  • Current diagnosis of dementia or delirium
  • MoCA total score \< 26
  • Current visual, auditory, or motor impairment that compromises ability to complete evaluations
  • Patients with intracranial implants
  • MRI contraindications: pregnancy, implanted metal, and claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DukeUMC

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DEVICE FEASIBILITY
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2015

First Posted

January 30, 2015

Study Start

February 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

March 22, 2017

Record last verified: 2016-08

Locations

US(1)