None listed
Conditions
Brief summary
The purpose of this project is to investigate whether an ‘optimised’ form of Magnetic Seizure Therapy (MST) is a successful treatment for patients with treatment resistant depression compared to the standard form of MST that has been used to date. MST involves the induction of a seizure for therapeutic purposes. It is similar to electroconvulsive therapy (ECT) but with MST the seizure is induced through the use of magnetic stimulation rather than direct electrical currents as occurs with ECT. By avoiding the use of direct electrical current when inducing the seizure, it is thought that MST will result in an improvement in depressive symptoms whilst reducing memory related side effects (i.e. difficulties in remembering recent events) which can occur with ECT. The standard from of MST that has been investigated to date is 100Hz MST to the vertex, or the ‘motor area of the brain’. 100Hz MST has been shown to improve depression in some people and to not have any of the memory side effects often seen with ECT. We will be comparing this form of MST to 25Hz MST to the prefrontal cortex, or the ‘front part of the brain’ to investigate whether this type of MST results in greater improvement in depression than the 100Hz MST.
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 initially undergo a dose titration procedure to establish their convulsive stimulation threshold. Single stimulation trains will be ap
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 initially undergo a dose titration procedure to establish their convulsive stimulation threshold. Single stimulation trains will be applied at 25 Hz to the prefrontal cortex. Patients will undergo a maximum of 15 treatment sessions over approximately 5 weeks. Treatment will be administered a psychiatric medical registrar with an anesthetist present. Number of treatment sessions will be determined by Professor Paul Fitzgerald (CI) on the basis of consultation with participant regarding their wishes and mental state. Stimulation is applied using the Magstim Magnetic Seziure Therapy device. Treatment duration is between 20-30 mins. Each treatment will be recorded (date, time of treatment and duration) by a research nurse.
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. ?Montgomery Asberg depression rating scale (MADRS) score of > 20(moderate – severe depression). 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 two months Presence of another DSM-IV Axis I psychiatric disorder (on MINI) other than bipolar disorder Presence of substance abuse or dependence during the last six months Current pregnancy Past history of stroke, neurodegenerative disorder or other major neurological illness
Outcome results
None listed