Magnetic Seizure Therapy (MST) for the Treatment of Major Depression (MST-2)

This study has been completed.
Sponsor:
Collaborators:
University of Texas
Stanley Medical Research Institute
Information provided by (Responsible Party):
Sarah Lisanby, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00973934
First received: September 4, 2009
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention Phase
Major Depressive Disorder
Device: Magstim Theta
Device: Thymatron System IV
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Magnetic Seizure Therapy (MST) for the Treatment of Major Depression

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Hamilton Rating Scale for Depression (HRSD), 24 item [ Time Frame: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Beck Depression Inventory [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Neuropsychological testings to assess the acute, short term, long term memory effects of the treatments [ Time Frame: 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. ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: April 2002
Study Completion Date: December 2009
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Magnetic Seizure therapy (MST)
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
Active Comparator: Right Unilateral Electroconvulsive Therapy Device: Thymatron System IV

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973934

Locations
United States, North Carolina
Duke Universtiy Medical Center
Durham, North Carolina, United States, 27710
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Sarah Lisanby
University of Texas
Stanley Medical Research Institute
  More Information

No publications provided

Responsible Party: Sarah Lisanby, Professor of psychiatry, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00973934     History of Changes
Other Study ID Numbers: 4371, 01-069
Study First Received: September 4, 2009
Last Updated: June 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014