None listed
Conditions
Brief summary
Major depressive disorder (MDD), as described in the DSM IV, is the most prevalent mental health disorder in New Zealand. It affects at least 5.3% of the population and consequently poses a substantial health, social and economic burden. A particularly concerning subpopulation of MDD is the treatment resistant (TR) class, defined as those patients who are unresponsive to at least two adequate courses of different antidepressant treatments. This subgroup makes up approximately 30% of the population with MDD. Over the past two decades, numerous randomised, double-blind, and sham-controlled trials summarised in multiple meta-analyses have established the efficacy of repetitive transcranial magnetic stimulation (rTMS) for the treatment of TR MDD. In addition to being a viable alternative to those that cannot tolerate or unresponsive to pharmacological treatments, rTMS also has the advantage of not posing adverse effects upon metabolism and sexual function as many pharmacological antidepressants do. Despite extensive research demonstrating the effectiveness of rTMS, understanding of the mechanisms underlying the antidepressant effects produced remains incomplete. This likely accounts for the unpredictability of whether patients will respond and the modest response rates. The aim of this study is to investigate the biological correlates of successful treatment outcomes with rTMS using magnetic resonance imaging.
Interventions
4,000 pulses of transcranial magnetic stimulation delivered by the research team to the left dorsal prefrontal cortex, at 10 Hz for 5 seconds every 15 seconds at 120% of motor threshold per session. Sessions will be completed each week day for 4 weeks (20 sessions). Stimulation location will be determined using the Beam F3 Method.
Sponsors
The university of Auckland
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Patient is willing and able to give informed consent for participation in the trial • Male or female, aged 18 years or above • In the Investigators’ opinion, is able and willing to comply with all trial requirements • Major depressive disorder for at least three months, as assessed by a Clinical Interview using DSM-IV criteria • MADRS >20 An inadequate response to at least two antidepressants courses one of which can include the current episode.
Exclusion criteria
• Contraindications to repetitive transcranial magnetic stimulation, assessed using the University of Auckland safety checklist • Contraindications for MRI as per the CAMRI screening form • History of psychosis • Any unstable medical or neurologic condition • Planned major changes to psychotropic medication • Imminent risk of suicide as determined by the CSSRS and clinical interview with a consultant psychiatrist • Planned or probable use of ECT • >2 years of depressive episode • Substance abuse or dependence in previous 6 months • Any other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial • Regular use of any medication deemed to be contraindicating as judged by the screening physicians • Inability to speak or read English • Pregnancy
Outcome results
None listed