Depression
Conditions
Keywords
neuronavigated, iTBS, Accelerated, RCT
Brief summary
The Investigators propose to carry out a randomized, double-blind trial to compare the clinical efficacy of an individualized connectome-guided accelerated iTBS vs an anatomically-guided (Beam F3) accelerated iTBS. The study team will recruit both inpatients and outpatients who had been referred for TMS for the treatment of depression.
Interventions
DEVICEBeam F3 targeted accelerated iTBS
Magpro X100, Axilium Cobot, Localite camera
Magpro X100, Axilium Cobot, Localite camera
Sponsors
National University of Singapore
Institute of Mental Health, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 21 years. 2. DSM-5 diagnosis of current Major Depressive Episode. 3. Montgomery-Asberg Depression Rating Scale score of 20 or more. 4. Inadequate response to an adequate trial (4 weeks) of at least one antidepressant medication. 5. Able to give informed consent.
Exclusion criteria
1. DSM-5 psychotic disorder 2. Drug or alcohol abuse or dependence (preceding 3 months). 3. Rapid clinical response required, e.g., high suicide risk. 4. Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy. 5. Metal in the cranium, skull defects, pacemaker, cochlear implant, medication pump or other electronic device. 6. Pregnancy. 7. Unsuitable for MRI.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Åsberg Depression Rating Scale | Baseline, immediately post treatment, 1 month and 3 months post intervention | Clinician rated depression rating scale, Scored 0 to 60, higher scores mean worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) | Baseline, daily during treatment (5 days), immediately post treatment, 1 month and 3 months post intervention | Participant rated depression rating scale, scored 0-27, higher scores mean worse outcome |
| Montreal Cognitive Assessment (MoCA) | Baseline, immediately post treatment, 1 month and 3 months post intervention | global cognitive functioning, scored 0-30, higher score means better outcome |
| EQ-5D (EuroQol) | Baseline, immediately post treatment, 1 month and 3 months post intervention | Quality of life scales, scored 0-100, higher scores mean better outcome |
| Quality of Life Enjoyment and Satisfaction Questionnaire Short form (Q-LES-QS-SF) | Baseline, immediately post treatment, 1 month and 3 months post intervention | Quality of life scales, scored 14-70, higher score means better outcome |
Other
| Measure | Time frame | Description |
|---|---|---|
| TMS induced changes in resting-fMRI functional connectivity | Baseline, immediately post treatment | The investigators will also perform additional exploratory posthoc analyses by analysing brain imaging changes before and after TMS |
Countries
Singapore
Contacts
Primary ContactPhern Chern Tor, MBBS
Outcome results
None listed