Individualised Theta Burst Transcranial Magnetic Stimulation (TBS) for Depressio
- Conditions
- DepressionMental Health - Depression
- Registration Number
- ACTRN12620000591954
- Lead Sponsor
- Monash University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 41
•Diagnosis of major depressive disorder as a single or recurrent episode, in accordance with the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-V) with Mini-International Neuropsychiatric Interview-confirmed diagnosis.
•18-80 years of age.
•Treatment resistant depression at Stage II of the Thase and Rush classification.
•Montgomery–Asberg Depression Rating Scale (MADRS) score of >19 (moderate–severe depression).
•No change or initiation of new antidepressant (or other psychoactive) therapy in the four weeks prior to screening.
•Demonstrated capacity to give informed consent.
•Inability to provide informed consent
•Medically unstable
•Concomitant neurological disorder or a history of a seizure disorder.
•Patients who are pregnant or breastfeeding.
•Active suicidal intent
•Any psychotic disorder or current active psychotic symptoms
•Patients who have intracranial implants.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Montgomery–Asberg Depression Rating Scale (MADRS)[Baseline, week 2, week 4 (primary timepoint) and week 8.<br><br>Response will be defined as a 50% reduction in the MADRS at week 4 from baseline.<br>Remission will be defined as a MADRS score < 7 at week 4. <br>]
- Secondary Outcome Measures
Name Time Method Quick Inventory of Depressive Symptoms (QIDS-SR)[Baseline, week 2, week 4 and week 8.];Beck Anxiety Inventory (BAI)[Baseline, week 2, week 4 and week 8.];Clinical Global Impression - Improvement (CGI-I)[Baseline, week 2, week 4 and week 8];Change in Clinical Global Impression– Severity (CGI-S)[Baseline, week 2, week 4 and week 8];EEG (including TMS-EEG):<br>We will assess the plastic changes of the brain comparing between before and after TBS treatment by using TMS-EEG results (e.g. N45, P60, N100 and P200).[Baseline, week 2 and week 4]