NCT00973934

Brief Summary

This two-center, between-subject, randomized, double-masked study (n=20) will provide the first evidence for the antidepressant efficacy of Magnetic Seizure Therapy (MST) and contrast the therapeutic properties and side effects of two forms of MST in patients in a major depressive episode (MDE).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2 major-depressive-disorder

Timeline
Completed

Started Apr 2002

Longer than P75 for phase_2 major-depressive-disorder

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

April 1, 2002

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 9, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 10, 2014

Status Verified

June 1, 2014

Enrollment Period

3.8 years

First QC Date

September 4, 2009

Last Update Submit

June 9, 2014

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Hamilton Rating Scale for Depression (HRSD), 24 item

    A blinded rater will administer the test at Baseline, every Tuesday and Thursday during the treatment course and at the end of the MST course

Secondary Outcomes (2)

  • Beck Depression Inventory

    A blinded rater will administer the test at Baseline, every Tuesday and Thursady during the treatment course and at the end of the MST course

  • Neuropsychological testings to assess the acute, short term, long term memory effects of the treatments

    A blinded rater will administer various neurospychologiocal tests at various timepoints (baseline, within 3 days following the MST course and at 2 months following the MST course. Treatment Effect Battery (TEB) will be administered at each MST session.

Study Arms (2)

Magnetic Seizure therapy (MST)

EXPERIMENTAL

Eligible patients will be randomized to receive either a course of thrice weekly MST using either a focal or non focal stimulating coil.

Device: Magstim Theta

Right Unilateral Electroconvulsive Therapy

ACTIVE COMPARATOR
Device: Thymatron System IV

Interventions

Magstim ThetaDEVICE
Magnetic Seizure therapy (MST)
Thymatron System IVDEVICE
Right Unilateral Electroconvulsive Therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of major depressive episode, in the context of unipolar or bipolar disorder
  • Age 18-75
  • Use of effective method of birth control for women of child-bearing capacity
  • Willing and capable of providing informed consent
  • Convulsive therapy clinically indicated
  • Hamilton Rating Scale for Depression (HRSD) ≥18 (24 item)

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, or structural brain lesion
  • Presence of devices that may be affected by rTMS (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Duke Universtiy Medical Center

Durham, North Carolina, 27710, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

  • 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

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of psychiatry

Study Record Dates

First Submitted

September 4, 2009

First Posted

September 9, 2009

Study Start

April 1, 2002

Primary Completion

January 1, 2006

Study Completion

December 1, 2009

Last Updated

June 10, 2014

Record last verified: 2014-06

Locations

US(2)