Clinical trial NCT02351843: Efficacy and Safety of Low Amplitude Electroconvulsive Therapy
Official title: Efficacy and Safety of Low Amplitude Electroconvulsive Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2015-01-30
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in California Verbal Learning Test-II
timeFrame: Baseline and within 24 to 48 hours of each ECT session
Secondary outcomes:
Other outcomes:
measure: Change in Hamilton Rating Scale for Depression 24-item
timeFrame: Baseline and within 24 to 48 hours of each ECT session
measure: Change in Quick Inventory of Depressive Symptomatology Clinician Rated and Self Report
timeFrame: Baseline and within 24 to 48 hours of each ECT session
measure: Change in Brief Visuospatial Memory Test-Revised
timeFrame: Baseline and within 24 to 48 hours of each ECT session
measure: Change in Autobiographical Memory Interview Test
timeFrame: Baseline and within 24 to 48 hours of each ECT session
measure: Change in Delis Kaplan Executive Function System
timeFrame: Baseline and within 24 to 48 hours of each ECT session
measure: Change in Trail Making Test Part A
timeFrame: Baseline and within 24 to 48 hours of each ECT session
measure: Change in Grooved Pegboard test
timeFrame: Baseline and within 24 to 48 hours of each ECT session
Locations:
city: Durham
country: United States
facility: DukeUMC
state: North Carolina
Study officials:
References: