Low Pulse Amplitude Focal ECT (LAP Study)
| Status: | Recruiting |
|---|---|
| Conditions: | Depression |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 20 - Any |
| Updated: | 4/17/2018 |
| Start Date: | March 2015 |
| End Date: | December 2019 |
| Contact: | Nagy Youssef, MD |
| Email: | nyoussef@augusta.edu |
| Phone: | 7067216963 |
Low Pulse Amplitude Focal Electroconvulsive Therapy
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.
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.
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.
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.
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
We found this trial at
1
site
Evans, Georgia 30809
Principal Investigator: Nagy Youssef, MD
Phone: 601-466-4200
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