Comparative Effectiveness Clinical Trial of Magnetic Seizure Therapy (MST) Compared to Electroconvulsive Therapy (MST) in Major Depressive Disorder
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Major Depressive Disorder
- Sponsor
- Tanta University
- Enrollment
- 60
- Primary Endpoint
- Time to reorientation (TRO)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This study was a prospective, open-label comparative effectiveness clinical trial, comparing magnetic seizure therapy (MST) to ECT in patients with Major Depressive Disorder (MDD).
Detailed Description
Magnetic seizure therapy (MST) has previously demonstrated fewer cognitive side effects than ECT in randomized trials of efficacy. However, there are currently no real-world effectiveness trials guided by the clinical decision making of the ECT psychiatrist as deemed best for the patient. The aims of this study are to: (1) Evaluate the comparative effectiveness of MST versus ECT in patients with MDD, and (2) Compare the cognitive adverse effects of MST and ECT, (3) Explore changes in SPECT that is associated with MST treatment and treatment response. Patients will be clinically assigned to either ECT (n=30) or HD-MST (n=30) twice a week. Efficacy will be primarily assessed by the Hamilton Depression Rating Scale-21 (HAMD-21); primary cognitive side effects were assessed by Time to Reorientation (TRO) and secondarily cognitive battery. Brain SPECT will be done for patients before and after MST.
Investigators
El-Sayed Gad
Professor
Tanta University
Eligibility Criteria
Inclusion Criteria
- •Ability to consent
- •Clinically indicated for seizure therapy
- •Patients with MDD who had either never received antidepressant treatment or had discontinued antidepressants by their own choice for at least six weeks prior to enrollment (as commonly done in routine clinical care in this jurisdiction due to more negative views of psychotropics)
- •18-65 years of age.
Exclusion Criteria
- •History of significant head trauma
- •Neurological disorders (e.g., epilepsy, stroke, multiple sclerosis)
- •Substance dependence
- •Active comorbidity with another psychiatric disorder
- •Patients who had previously received ECT or TMS
- •Current unstable or serious medical illness (e.g., myocardial infarction)
- •Presence of implanted electronic devices (e.g., cardiac pacemaker, cochlear implants)
- •Inability to participate in testing
Outcomes
Primary Outcomes
Time to reorientation (TRO)
Time Frame: approximately 2.5 weeks
Cognition primarily assessed by Time to Reorientation (TRO)
Depression Scale
Time Frame: approximately 2.5 weeks
Efficacy primarily assessed by Hamilton Depression Scale-21 (HAM-D-21)
Secondary Outcomes
- Brain Single Photon Emission Computed Tomography (SPECT)(approximately 2.5 weeks)
- Wechsler Memory Scale - Revised:(approximately 2.5 weeks)
- Wisconsin Card Sorting Test(approximately 2.5 weeks)