A cohort study of neuromodulation interventions for major depressive disorder

This joint PhD project is based at the Shanghai Jiao Tong University with a minimum 12 month stay at The University of Melbourne.

This study aims to explore the efficacy, safety and long term effects of non-invasive neuromodulation techniques on major depressive disorder, and to provide data for establishing a prediction model. 400 patients will be recruited and randomly assigned to one of 4 treatment groups.  They will be assessed at baseline and at two weeks, four weeks, eight weeks, three months, six months, and one year after enrolment. Efficacy of different treatments will be analysed based on reduction in HAMD scores, response rates and recurrence rates. A prediction model will be built upon their demographic and clinical data utilising machine learning methodologies.

The purpose of this study is to explore the efficacy, safety and long-term effects of non-invasive neuromodulation techniques in the treatment of major depressive disorder and to provide data for the establishment of prediction models.

This study will include 400 patients who meet the DSM-5 diagnostic criteria for major depressive disorder and who currently have a “moderate or severe depressive episode” and have failed to respond to at least one type of antidepressant medication. Enrolled patients will be randomly assigned to the drug therapy group (control group), the drug therapy combined with rTMS group, the drug treatment combined with tDCS group, and the drug therapy combined with ECT group. Patients will be followed-up at weeks two, four and eight.

Patients who demonstrate lack or response in their treatment group will have the opportunity to enter another treatment group of their choice. The long-term follow-up time points are 12, 24, 36 and 48 weeks after treatment. Depressive symptoms will be assessed to determine whether recurrence occurs.

The enrolled patients will receive antidepressant monotherapy (positive control group), or antidepressant combined with a neuromodulation treatment. The medication used will be at the discretion of the treating psychiatrist, in consultation with the patient. Operators, clinical evaluators and patients will not be blinded throughout the study.

The primary outcome is reduction in patients’ HAMD scores, while the secondary outcome measures are response rate (reduction of total HAMD17 score after treatment ≥50% compared with baseline), remission rate (HAM-D ≤ 7), adverse reaction rate, recurrence rate, and level of social functioning. The prediction model will be built based on these data sets, utilising machine learning methodologies.

All participants will be recruited in Shanghai and followed up by the SJTU research group.  Shanghai has a much larger pool of eligible patients compared to Melbourne, and the advantage of establishing the project in Shanghai is the accessibility of a large patient sample. Once all follow-up activities are completed and data are collected, the joint PhD candidate will conduct data analysis and prediction model building in Melbourne.

The University of Melbourne has advanced data analysis capabilities to enable these tasks. The candidate will also benefit from strong training in research writing and clinical research support from The University of Melbourne.

The project will be complemented by the project Brain imaging predictors of rapid treatment response to low-dose ketamine in patients with severe depression and the collaboration will ensure a successful completion of the project.

Supervision team:

Professor Yiru Fang (Shanghai Jiao Tong University)

Professor Christopher Davey (The University of Melbourne)