NCT00488748

Brief 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. 1.MST and ECT will have similar antidepressant efficacy.
  2. 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. 3.At follow up, MST will show a lesser degree of persisting deficit in measures of retrograde amnesia than ECT.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for phase_3 depression

Timeline
Completed

Started Jun 2007

Longer than P75 for phase_3 depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2007

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

January 28, 2015

Status Verified

January 1, 2015

Enrollment Period

5.2 years

First QC Date

June 18, 2007

Last Update Submit

January 16, 2015

Conditions

Depression

Keywords

MSTMagnetic Seizure TherapyECTElectroconvulsive TherapyDepressionMagnetic

Outcome Measures

Primary Outcomes (1)

  • Clinical improvement (Hamilton Rating Scale for Depression)

    After each treatment and at follow-ups up to 6 months after the treatment course

Secondary Outcomes (1)

  • Clinical improvement (Inventory of Depressive Symptomatology - Clinician-Rated)

    Before and after treatment course, and at follow-ups up to 6 months after the treatment course

Study Arms (2)

MST

EXPERIMENTAL

Magnetic Seizure Therapy (MST)

Device: Magstim Theta

ECT

ACTIVE COMPARATOR

Electroconvulsive Therapy (ECT)

Device: Thymatron

Interventions

ThymatronDEVICE

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

Also known as: Thymatron, Electroconvulsive Therapy (ECT)
ECT
Magstim ThetaDEVICE

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

Also known as: Magstim Theta, Magnetic Seizure Therapy (MST)
MST

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-90
  • Clinical diagnosis of major depressive episode, in the context of unipolar or bipolar disorder
  • Use of effective method of birth control for women of child-bearing capacity
  • Willing and capable to provide informed consent
  • Convulsive therapy clinically indicated
  • Hamilton Rating Scale for Depression (HRSD24) ≥ 20

You may not qualify if:

  • Current unstable or serious medical condition, or any comorbid medical condition that substantially increases the risks of ECT (such as acute myocardial infarction, space occupying brain lesion or other cause of increased intracranial pressure, unstable aneurysm or vascular malformation, poorly controlled diabetes mellitus, carcinoma, renal failure, hepatic failure)
  • Pregnancy
  • History of neurological disorder, epilepsy, stroke, brain surgery, metal in the head, history of known structural brain lesion
  • Presence of devices that may be affected by MST (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
  • Breast-feeding
  • History of head trauma with loss of consciousness for greater than 5 minutes
  • History of schizophrenia, schizoaffective disorder, or rapid cycling bipolar disorder
  • Vagus nerve stimulator implanted
  • History of substance abuse or dependence in past 3 months
  • Failure to respond to an adequate course of ECT in the current depressive episode
  • History of ECT in the past 6 months and/or failure to respond to an adequate trial of ECT lifetime
  • Presence of intracardiac lines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Duke University

Durham, North Carolina, 27710, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (4)

  • Lisanby SH, Luber B, Schlaepfer TE, Sackeim HA. Safety and feasibility of magnetic seizure therapy (MST) in major depression: randomized within-subject comparison with electroconvulsive therapy. Neuropsychopharmacology. 2003 Oct;28(10):1852-65. doi: 10.1038/sj.npp.1300229.

    PMID: 12865903BACKGROUND

  • Kosel M, Frick C, Lisanby SH, Fisch HU, Schlaepfer TE. Magnetic seizure therapy improves mood in refractory major depression. Neuropsychopharmacology. 2003 Nov;28(11):2045-8. doi: 10.1038/sj.npp.1300293.

    PMID: 12942146BACKGROUND

  • Deng ZD, Luber B, McClintock SM, Weiner RD, Husain MM, Lisanby SH. Clinical Outcomes of Magnetic Seizure Therapy vs Electroconvulsive Therapy for Major Depressive Episode: A Randomized Clinical Trial. JAMA Psychiatry. 2024 Mar 1;81(3):240-249. doi: 10.1001/jamapsychiatry.2023.4599.

    PMID: 38055283DERIVED

  • Jiang J, Zhang C, Li C, Chen Z, Cao X, Wang H, Li W, Wang J. Magnetic seizure therapy for treatment-resistant depression. Cochrane Database Syst Rev. 2021 Jun 16;6(6):CD013528. doi: 10.1002/14651858.CD013528.pub2.

    PMID: 34131914DERIVED

Related Links

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Sarah H. Lisanby, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor and Chair, Department of Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

June 18, 2007

First Posted

June 20, 2007

Study Start

June 1, 2007

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

January 28, 2015

Record last verified: 2015-01

Locations

US(2)