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

Major Depressive Disorder Clinical Trial

— MST-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00973934
• Other study ID #: 4371
• Secondary ID: 01-069
• Status: Completed
• Phase: Phase 2
• First received: September 4, 2009
• Last updated: June 9, 2014
• Start date: April 2002
• Est. completion date: December 2009

Study information

• Verified date: June 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2009
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• Magstim Theta

• Thymatron System IV

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Duke Universtiy Medical Center	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Sarah Lisanby	Stanley Medical Research Institute, University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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.	Yes