Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00488748
Other study ID # Pro00026868
Secondary ID Stanley Grant #0
Status Completed
Phase Phase 3
First received June 18, 2007
Last updated January 16, 2015
Start date June 2007
Est. completion date August 2012

Study information

Verified date January 2015
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 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.


Description:

The purpose of this study is to 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. ECT is known to be highly effective in treating depression, but it can have some adverse cognitive side effects. MST is a new form of convulsive therapy that is being developed as a means of improving the side effect profile of ECT so that more patients may benefit without suffering significant detrimental effects on cognition.

Both ECT and MST cause a seizure, but they do so in different ways. In ECT, an electrical stimulator is used to pass an electrical current between two electrodes placed on the person's head, which causes some electricity to go through the brain and cause a seizure. In MST, a magnetic stimulator is used to pass a magnetic field to the brain, which then creates a small electrical field in the brain that causes a seizure.

In addition to the treatment sessions, this study will involve a number of assessments at different timepoints that are used to evaluate the person's antidepressant response and the physical and cognitive side effects of treatment.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- 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

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, 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Device:
Thymatron
Right unilateral placement, 6x seizure threshold, 3 times per week until clinically appropriate to stop (approximately 2-6 weeks)
Magstim Theta
100% power, vertex placement, 3 times per week, until clinically appropriate to stop (approximately 2-6 weeks)

Locations

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

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical improvement (Hamilton Rating Scale for Depression) After each treatment and at follow-ups up to 6 months after the treatment course No
Secondary 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 No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A