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Magnetic Seizure Therapy (MST) for Severe Mood Disorder

NCT00488748 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2015-01-28

No results posted yet for this study

Summary

This study will compare the clinical efficacy and side effects of Magnetic Seizure Therapy (MST) and Electroconvulsive Therapy (ECT) in patients currently experiencing a major depressive episode in the context of either unipolar or bipolar depression. The investigators will conduct a number of clinical and neuropsychological tests to assess clinical and cognitive response to treatment. The investigators hypothesize that:

1. MST and ECT will have similar antidepressant efficacy.
2. MST will have less post-treatment amnesia than ECT as reflected in primary measures of anterograde and retrograde amnesia following the acute treatment phase.
3. At follow up, MST will show a lesser degree of persisting deficit in measures of retrograde amnesia than ECT.

Conditions

Interventions

DEVICE

Thymatron

Right unilateral placement, 6x seizure threshold, 3 times per week until clinically appropriate to stop (approximately 2-6 weeks)

DEVICE

Magstim Theta

100% power, vertex placement, 3 times per week, until clinically appropriate to stop (approximately 2-6 weeks)

Sponsors & Collaborators

  • Duke University

    collaborator OTHER

  • University of Texas Southwestern Medical Center

    collaborator OTHER

  • Stanley Medical Research Institute

    collaborator OTHER

  • Sarah Lisanby

    lead OTHER

Principal Investigators

  • Sarah H. Lisanby, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00488748 on ClinicalTrials.gov