Depression
Conditions
Keywords
Electroconvulsive Therapy, Low Pulse Amplitude Focal Electroconvulsive Therapy, ECT, Depression, Suicidal Ideation
Brief summary
This protocol proposes a pilot randomized clinical trial to examine whether Low Pulse Amplitude Focal ECT (LAP) has a more favorable cognitive profile compared to conventional unilateral ECT and that it has similar effects as traditional ECT in reducing suicidality. The study will enroll 10 patients recruited from the Medical College of Georgia (at Georgia Regents University/Augusta University, GRU/AU) as the only site of the study. Eligible participants will be randomly assigned (1:1 ratio) to receive a course of either RUL LAP ECT, or conventional RUL ECT.
Detailed description
Lower amplitude ECT (LAP) has been shown to induce seizures of adequate duration in a single titration session. This current study is hypothesized to increase stimulation focality, thus hypothetically minimizing cognitive side effects. The central hypothesis is that LAP has significantly less cognitive adverse effects compared to conventional Right Unilateral (RUL) ECT. The study will enroll 10 patients recruited from Medical College of Georgia. Patients referred to ECT service in the Medical College of Georgia usually occurs from clinical services and private physicians and the study will recruit patients who are clinically indicated to do ECT. Eligible participants will be randomly assigned (1:1 ratio) to receive a course of either RUL LAP ECT, or conventional RUL ECT.
Interventions
DEVICEspectrum 5000Q ECT device (RUL ECT)
DEVICEspectrum 5000Q ECT device (RUL LAP ECT)
Sponsors
Augusta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients in whom ECT therapy is clinically indicated * Males or females patients over 20 years of age * Current DSM-IV criteria for major depressive episode * Montgomery-Asberg depression rating scale (MADRS) greater than or equal to 20 * Use of effective method of birth control for women of child-bearing capacity * Patient is medically stable * No anticipated need to alter psychotropic medications for the duration of the study * Ability of patient to fully participate in the informed consent process
Exclusion criteria
* Unstable or serious medical condition that substantially increases risks of ECT or of cognitive impairment * Substance use disorders within 1 week of randomization * History of neurological disorder, epilepsy, stroke, brain surgery, metal in the head, history of known structural brain lesion that is deemed to affect cognition or safe ECT treatment * Vagal Nerve Stimulator implanted * Female patients who are pregnant or plan to be pregnant during the study breast-feeding * Implanted devices that make ECT unsafe, or a skull defect * Significant cognitive impairment (Mini-Mental State Examination (MMSE) less than 24) * ECT in the past 1 months * Benzodiazepine use will be limited to no more than 3 mg per day of lorazepam or its equivalents. Antidepressants and antipsychotics will be held constant during the ECT course of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Memory (cognitive side effects) | From Baseline to end of acute course (typically after 4 weeks) | Measured by Autobiographic Memory Interview-Short form (AMI-SF, primary outcome) |
| Time to reorientation | From Baseline to end of acute course (typically after 4 weeks) | Measured by Time to Orientation Test (TRO, primary outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resilience | From Baseline to end of acute course (typically after 4 weeks) | Connor-Davidson Resilience Scale |
| Suicidal Ideation | From Baseline to end of acute course (typically after 4 weeks) | — |
| Depression | From Baseline to end of acute course (typically after 4 weeks) | used to determine remission status; measured by Montgomery-Åsberg Depression Rating Scale (MADRS) |
| Trauma symptoms | From Baseline to end of acute course (typically after 4 weeks) | PTSD Checklist |
Countries
United States
Outcome results
None listed