Low Pulse Amplitude Focal ECT (LAP Study)

Completed · Phase 3

Conditions studied: Depression

In brief

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.

Key facts

Study ID

NCT02583490

Run by

Augusta University

People needed

11

Starts

2015-03-01

Expected to finish

2018-08-01

Last updated by the study team

2019-06-20

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Medical Colleage of Georgia, Augusta University — Evans, Georgia, United States

Full record on ClinicalTrials.gov

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