None listed
Conditions
Brief summary
Electro convulsive therapy (ECT) remains the only established treatment for the large percentage of patients with depression who fail to respond to standard therapies. It is commonly used (with 10 to 15% of inpatients with depression receiving ECT) but has substantial problems including the occurrence of cognitive side effects that are often highly distressing for patients. ECT is associated with both short term and long term cognitive side effects. The short term effects include anterograde and retrograde memory loss and post treatment disorientation which can be distressing, dangerous and significantly slow treatment progress. In the longer term, ECT can affect autobiographical memory which can be very distressing to patients. The development of a new treatment with similar efficacy but which minimises these side effects would have great clinical value. A highly promising possibility is magnetic seizure therapy (MST). MST involves replacing the electrical stimulation used in ECT with a magnetic stimulus. This appears to be able to produce similar clinical effects but without the disabling cognitive side effects related to ECT. However, substantive trials using the newest MST equipment are required. Due to the rarity of the equipment available so far, these studies are only being undertaken in a handful of places internationally and no research with MST has occurred. Building on a pilot study conducted by the applicants, we propose to undertake a substantive head-to-head trial of MST versus ECT. There will be a total of 60 patients in the study undertaking a treatment course of between 9 and 15 treatments. Baseline and endpoint assessments will be undertaking to investigate efficacy, these will include clinical assessments, cognitive assessments and neurophysiological assessment If MST proves to be as efficacious as ECT, but with fewer side effects, we anticipate that it could be rapidly adopted in clinical practice. All of the facilities are available for the provision of MST in every substantive mental health service in the country (in current ECT suites / facilities); all that would be required would be the replacement of the ECT machine with MST equipment for seizure induction. Fewer cognitive side effects will enhance patient outcomes and improve treatment acceptability and hence access. In addition, a reduced duration of post treatment disorientation will shorten the period of post treatment observation required enhancing capacity for convulsive therapy to be provided on an outpatient basis, lessening demand on inpatient psychiatric services.
Interventions
Magnetic Seizure Therapy (MST).
MST uses magnetic stimulation to induce a seizure for therapeutic purposes. Magnetic stimulation is a non invasive technique for stimulating neural tissue. A rapid change in magnetic field induces a current in the neural tissue. If the current is of sufficient amplitude and duration it will excite nerve tissues.
All patients will undergo a dose titration procedure to establish their convulsive stimulation threshold using 10 second trains at 100Hz. Stimulatio
Magnetic Seizure Therapy (MST). MST uses magnetic stimulation to induce a seizure for therapeutic purposes. Magnetic stimulation is a non invasive technique for stimulating neural tissue. A rapid change in magnetic field induces a current in the neural tissue. If the current is of sufficient amplitude and duration it will excite nerve tissues. All patients will undergo a dose titration procedure to establish their convulsive stimulation threshold using 10 second trains at 100Hz. Stimulation will then be provided at 120% of seizure threshold. Patients will undergo a maximum of 15 treatment sessions over approximately 5 weeks. Stimulation is applied using the Magstim Magnetic Seziure Therapy device. Treatment duration is between 20-30 mins.
Sponsors
Professor Paul Fitzgerald
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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
Outcome results
None listed