Efficacy and Safety of Low Amplitude Electroconvulsive Th... | NCT02351843

Studies
Efficacy and Safety of Low Amplitude Electroconvulsive Therapy

NCT02351843

Sponsor

Duke University

Status

Terminated

Last Update Posted

Mar 22, 2017Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

Depression

Interventions

MECTA Spectrum 5000Q

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Nov 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Jan 27, 2015

First Submission Date that Met QC Criteria

Jan 27, 2015

First Posted Date

Jan 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2017

Last Update Posted Date

Mar 22, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
MECTA Spectrum 5000Q	Device		500 mA ECT 800 mA ECT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in California Verbal Learning Test-II		Baseline and within 24 to 48 hours of each ECT session

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior