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NCT02583490 · ClinicalTrials.gov registry record · Phase 3

Low Pulse Amplitude Focal ECT (LAP Study)

A Phase 3 study, sponsored by Augusta University.

Completed
Registry status
Phase 3
Development phase
11
Enrollment target

NCT02583490: Completed Phase 3 study, sponsored by Augusta University.

NCT02583490 is a Phase 3 study that has completed, run by Augusta University. The registered enrollment target is 11 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02583490, a Phase 3 study, has completed, sponsored by Augusta University.

COMPLETED
Registry status
Phase 3
Development phase
11 participants
Enrollment target

Study 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.

Primary Outcome

Measured by Autobiographic Memory Interview-Short form (AMI-SF, primary outcome)

Interventions

  • DEVICE spectrum 5000Q ECT device (RUL ECT)
  • DEVICE spectrum 5000Q ECT device (RUL LAP ECT)

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2015-03
Est. Completion 2018-08
Phase Phase 3
Augusta University

106 total trials

What the finished NCT02583490 record still lists

NCT02583490 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which spectrum 5000Q ECT device (RUL ECT) is the first listed.

NCT02583490 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02583490 about?

NCT02583490 is a clinical study titled "Low Pulse Amplitude Focal ECT (LAP Study)". 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...

What is the current status of trial NCT02583490?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 11 participants. The study started on 2015-03. Estimated completion is 2018-08.

What interventions are being tested in trial NCT02583490?

The interventions under investigation include: spectrum 5000Q ECT device (RUL ECT) (DEVICE), spectrum 5000Q ECT device (RUL LAP ECT) (DEVICE).

Who is sponsoring clinical trial NCT02583490?

This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02583490's enrollment target sits among peer trials

11 1989th of 2000 higher than 12 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02583490, the US trial registry maintained by the National Library of Medicine. NCT02583490 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.