None listed
Conditions
Brief summary
Major depressive disorder is a severe illness of high prevalence. A significant percentage of patients fail to respond to standard treatments and continue to experience marked disability and high morbidity. Repetitive transcranial magnetic stimulation (rTMS) has been subject to intensive evaluation as an antidepressant strategy especially in patients with treatment resistant depression (TRD). Previous research conducted by our group and others clearly indicates that rTMS has antidepressant activity and that the response to rTMS is clinically meaningful. It is now being increasingly used in clinical practice in the US and more recently in Australia. A major barrier to the utilisation of rTMS is a relatively slow rate of response to treatment, often requiring daily treatments over a four to six week period. Therefore rTMS, as it currently stands, requires a considerable time commitment from both patients and clinicians. In addition, it is not considered appropriate for acutely suicidal patients, with these patients currently requiring treatment with electroconvulsive therapy (ECT) as this is clearly the most rapidly acting antidepressant treatment. If the time to response to rTMS could be substantially compressed, the treatment would be cheaper to administer and more acceptable to patients. In addition, it would also become a viable alternative strategy for the treatment of patients with acute suicidal ideation and other acute depression related risks, for example patients who have stopped eating and drinking and require intervention with a rapidly acting treatment. Therefore, the primary goal of this study is to investigate whether response to rTMS can be substantially enhanced through the use of an accelerated treatment protocol. We will compare antidepressant response between a standard and an accelerated rTMS protocol.
Interventions
Repetitive Transcranial Magnetic Stimulation (rTMS).
TMS will be administered with a Medtronic Magpro30 magnetic stimulator using a 70mm figure-of-8 coil. Prior to the commencement of rTMS treatment, single pulse TMS will be used to measure the resting motor thresholds (RMT) for the abductor pollicis brevis (APB) bilaterally in all subjects using standard published methods.
Patients will be randomised to one of two treatment conditions:
1. Three treatment sessions daily over three consecutiv
Repetitive Transcranial Magnetic Stimulation (rTMS). TMS will be administered with a Medtronic Magpro30 magnetic stimulator using a 70mm figure-of-8 coil. Prior to the commencement of rTMS treatment, single pulse TMS will be used to measure the resting motor thresholds (RMT) for the abductor pollicis brevis (APB) bilaterally in all subjects using standard published methods. Patients will be randomised to one of two treatment conditions: 1. Three treatment sessions daily over three consecutive days in week one, two days in week two and one day in week three (total of 18 treatments). The three treatment sessions will provide 83, 83 and 84 trains respectively of 10 Hz rTMS to the left DLPFC. 4.5 second trains will be applied at 120% of the resting motor threshold with a 15 second inter-train interval, each session will take approximately 27 minutes (10,500 pulses per day across the three sessions). 2. Daily treatment sessions provided on week days over four consecutive weeks (total of 20 treatments). Each treatment sessions will involve the provision of 75 trains of 10Hz rTMS to the left DLPFC. 4.5 second trains will be applied at 120% of the resting motor threshold with a 10 second inter-train interval (3150 pulses per session over 24 minutes). Patients will receive an assessment at baseline, 1, 2, 3, and 4 weeks (briefer assessments at weeks 1, 2 and 3), and the primary study analysis will be based on this data.
Sponsors
Professor Paul Fitzgerald
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Patients will be included if they: 1. Have a DSM-IV diagnosis of a Major Depressive Episode 2. Have treatment resistant depression at Stage II of the Thase and Rush Classification 3. Have a Hamilton Depression Rating Scale of >20 (moderate-severe depresssion). 4. Have had no increase in, or initiation of new antidepressant (or other psychoactive) therapy in the four weeks prior to screening.
Exclusion criteria
1. Patients who have an unstable medical condition(s), neurological disorder or any history of a seizure disorder or are currently pregnant or lactating or are professional drivers. 2. Have a current DSM-IV diagnosis of Substance Abuse or Dependence disorder, a diagnosis of a personality disorder (SCID II), or another Axis 1 disorder.
Outcome results
None listed