ACTRN12611000054910
Completed
Not Applicable
A randomised controlled trial of Magnetic Seizure Therapy for the treatment of Major Depressive Disorder
Professor Paul Fitzgerald0 sites40 target enrollmentJanuary 17, 2011
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Professor Paul Fitzgerald
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18\-75 and a DSM\-IV diagnosis of a major depressive episode (uni or bipolar depression) (diagnosis made using the standard structured clinical interview for the DSM\-IV (SCID I) instrument).
- •Patients with psychotic symptoms as part of their mood episode will not be excluded if able to give informed consent.
- •Are referred for or are otherwise suitable for a course of ECT as determined by their treating psychiatrist
- •Hamilton Depression Rating Scale (17 item version) score of \> 18 (moderate – severe depression): note – some authors have defined moderate depression on the 17 item HAMD as \>14\. We have selected a higher cut off to ensure all patients clearly have depression of substantial clinical severity. It is likely that most patients will have scores in the severe or extremely severe ranges.
- •Score greater than 23 on the Mini Mental State Examination
- •Have treatment resistant depression at Stage II of the Thase and Rush classification. This requires failure to respond to adequate courses of several courses of antidepressants.
- •Demonstrated capacity to give informed consent
Exclusion Criteria
- •Patients who are too unwell to undergo general anesthetic.
- •Patients with metallic implants in the head, cardiac pacemakers, cochlear implants or other implanted electronic devices
- •Treatment with ECT in the last three months
- •Presence of another DSM\-IV Axis I psychiatric disorder (on SCID I) other than bipolar disorder
- •Presence of substance abuse or dependence during the last six months (on SCID I)
- •Current pregnancy
- •Past history of stroke, neurodegenerative disorder or other major neurological illness
Outcomes
Primary Outcomes
Not specified
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