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Investigating predictors of response to Transcranial Magnetic Stimulation for the treatment of depression

Investigating predictors of the antidepressant efficacy of Transcranial Magnetic Stimulation

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610001071011
Enrollment
113
Registered
2010-12-06
Start date
2011-01-21
Completion date
2015-02-02
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Major depressive disorder (MDD) is common, associated with considerable disability and high morbidity and often resistant to treatment with standard approaches (~30% of patients meet standard definitions for treatment resistant depression (TRD)). There is currently an overwhelming need in the community for the development of better and novel treatments for depression. Despite the demand, there are relatively few treatment options available to patients with TRD. One of the only substantially new treatments developed in recent years has been repetitive transcranial magnetic stimulation (rTMS). Despite the considerable bulk of evidence demonstrating that rTMS can be effective in the treatment of depression, a major issue that limits its wider use is that only between 40-50% of patients respond to rTMS treatment. While this is a good response rate in a group of patients with significant depression who have failed to respond to other treatments, participation in rTMS treatment involves a considerable commitment of time and resources (stimulation is usually provided five days per week to outpatients who attend for up to six weeks). It is therefore essential to be able to identify patients who are more or less likely to respond to treatment. This research aims to provide a practical and clinically useful approach to predicting antidepressant response to rTMS treatment. In addition, by providing greater information about the underlying causes of depression and how these interact with treatments, this research may ultimately assist in developing more effective therapies for TRD. This would have a significant impact on the considerable numbers of Australians with depression who have tried standard therapies and yet remain significantly unwell. Therefore the current project aims to use both novel and more established neuroscience methodologies (namely electroencephalogy (EEG), TMS and near infra-red spectroscopy (NIRS)) to investigate whether such techniques can be used to predict response to rTMS treatment in depression.

Interventions

Transcranial Magentic Stimulation (TMS). 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. Patients will receive left sided high frequncy TMS intially, if they do not respond after three weeks they will be randomised to either; continue left sided high frequnecy treatment, crossover over to right sided low

Transcranial Magentic Stimulation (TMS). 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. Patients will receive left sided high frequncy TMS intially, if they do not respond after three weeks they will be randomised to either; continue left sided high frequnecy treatment, crossover over to right sided low frequency TMS or sequential bilateral TMS (i.e. right sided low frequency followed by left sided high frequency). Daily treatment (Mon-Fri) at 110% of motor threshold, for between 5 and 8 weeks.

Sponsors

Professor Paul Fitzgerald
Lead SponsorIndividual

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

Have a DSM-IV diagnosis of a Major Depressive Episode (SCID II). Are aged 18-75. Have treatment resistant depression at Stage III of the Thase and Rush classification (27). Have a Hamilton Depression Rating Scale (HAMD) score of > 20 (moderate to severe depression). Have had no increase or initiation of new antidepressant (or other psychoactive) therapy in the 4 weeks prior to screening

Exclusion criteria

Have an unstable medical condition, neurological disorder, any history of a seizure disorder, or are currently pregnant or lactating. In the opinion of the investigator, are at sufficient risk of suicide to require immediate electroconvulsive therapy. 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. Control participants will have no history of neurological or psychiatric illness and be taking no medications.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 21, 2026