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Neurobiological correlates of improvements in depression with repetitive transcranial magnetic stimulation

Sleep-wake cycle, neuropsychological and neurochemical correlates of improvements in depression in young people with repetitive transcranial magnetic stimulation treatment

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000416594
Enrollment
160
Registered
2015-05-01
Start date
2015-05-01
Completion date
2018-08-01
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

Repetitive transcranial magnetic stimulation has been shown to be efficacious for treating depression and has been approved by the TGA for the treatment of depression in adults who have not responded to at least 2 trials of antidepressant medications. However, some people do not respond to the treatment. Sleep-wake cycle disruption, reduced cognitive functioning and changes in brain chemistry are prominent features of depression. It is unclear how rTMS affects these features and whether they are associated with response to rTMS treatment. We seek to investigate whether these features of patients are associated with rTMS treatment response.

Interventions

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive procedure which has been approved by the TGA to treat depression in adults who have failed to respond to at least 2 adequate trials of an antidepressant medication. Our rTMS protocol involves 20 sessions of 20 minutes over 4 weeks. rTMS sessions will be administered for 5 days in a row with a 2 days break in between (i.e. rTMS from Monday through to Friday and no rTMS on Saturday and Sunday) and can commence on either weekday

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive procedure which has been approved by the TGA to treat depression in adults who have failed to respond to at least 2 adequate trials of an antidepressant medication. Our rTMS protocol involves 20 sessions of 20 minutes over 4 weeks. rTMS sessions will be administered for 5 days in a row with a 2 days break in between (i.e. rTMS from Monday through to Friday and no rTMS on Saturday and Sunday) and can commence on either weekday or weekend depending on nursing staff timetabling. rTMS will be administered using a MagPro R30 (MagVenture). A single pulse to the motor cortex will measure motor threshold (MT) before commencement of treatment. High-frequency (20 Hz) stimulation at 120% of MT will be applied to the left dorsolateral prefrontal cortex left for 45 trains of 4 seconds with 26 seconds between trains (i.e. 1800 pulses per day). Site of stimulation will be determined using the Acsension MINIBIRD tracker in combination with MRIcro/MRIreg software packages and a 3D structural T1-weighted MRI scan, according to a standard technique.

Sponsors

University of Sydney
Lead SponsorUniversity

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 30 Years
Healthy volunteers
No

Inclusion criteria

aged 18-30 years old with stable moderate to severe depressive symptoms and who have not responded to at least two adequate trials of antidepressant medications.

Exclusion criteria

Current diagnosis of epilepsy; mania, psychosis, high suicidal risk, and severe restrictive eating disorders; major developmental disorders; current alcohol and other substance use disorders; major medical illness; intellectual disability or inability to provide informed consent; poor English speaking; history of sustained head injury (loss of consciousness > 30 minutes); pregnancy; contraindication to MRI scanning.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026