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NCT01065597 · ClinicalTrials.gov registry record · Phase 1
Nonconvulsive Electrotherapy: a Proof-of-concept Trial
A Phase 1 study, sponsored by University of Maryland, College Park.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT01065597: Completed Phase 1 study, sponsored by University of Maryland, College Park.
NCT01065597 is a Phase 1 study that has completed, run by University of Maryland, College Park. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01065597, a Phase 1 study, has completed, sponsored by University of Maryland, College Park.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This study involves pilot testing of a modified version of a proven treatment for mental illness. The treatment, electroconvulsive therapy (ECT) is used to treat more than 100,000 Americans yearly. ECT is the most effective treatment for major depression, a disorder that affects approximately 5 to 8 percent of the adult US population yearly. It is also an effective treatment for mania and mixed mood states associated with bipolar disorder and schizoaffective disorder. The aim of ECT is to induce a seizure, which is thought to be responsible for both its therapeutic and its adverse cognitive effects. The proposed modification consists of reducing the ECT electrical stimulus dose below the amount necessary to induce seizures so that adverse cognitive effects, such as confusion and memory problems, are minimized. The investigators intend to determine whether ECT-related cognitive impairment can be reduced without diminishing the therapeutic effect of ECT. In addition to distressing patients, ECT-related cognitive impairment has significant public health consequences. These include increased morbidity and mortality among severely ill individuals who refuse ECT due to concern over its adverse cognitive effects as well as increased falls among the elderly receiving ECT. Elderly patients are far more likely to receive ECT and are also more vulnerable to ECT-related cognitive impairment. They often require hospitalization for ECT and a longer hospital stay with greater spacing of treatments to minimize adverse cognitive effects. The hypothesis driving this research is that electrical brain stimulation applied in the same manner as standard ECT, but at a lower dose, can have therapeutic effects and fewer adverse cognitive effects without inducing seizures. This hypothesis is based on the following: 1) the investigators clinical experience of patients who have improved with ECT despite having only one or no seizure, 2) animal studies showing that electrical brain stimulati
Primary Outcome
Score range is 0 to 54 points. The higher the score, the more depressed symptoms.
Interventions
- DEVICE Nonconvulsive electrotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2010-05 |
| Est. Completion | 2014-04 |
| Phase | Phase 1 |
What the finished NCT01065597 record still lists
NCT01065597 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which Nonconvulsive electrotherapy is the first listed.
NCT01065597 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01065597 about?
NCT01065597 is a clinical study titled "Nonconvulsive Electrotherapy: a Proof-of-concept Trial". This study involves pilot testing of a modified version of a proven treatment for mental illness. The treatment, electroconvulsive therapy (ECT) is used to treat more than 100,000 Americans yearly. ECT is the most effective treatment for major depression, a disorder that affects approximately 5 to 8...
What is the current status of trial NCT01065597?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2010-05. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01065597?
The interventions under investigation include: Nonconvulsive electrotherapy (DEVICE).
Who is sponsoring clinical trial NCT01065597?
This trial is sponsored by University of Maryland, College Park, which has 46 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01065597's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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