Depression Disorder
Conditions
Keywords
Depression, Neuronavigated, iTBS, RCT, Accelerated, Anxiety
Brief summary
This proposal seeks to carry out a double-blinded, randomized, comparative study that investigates neurobehavioral changes induced by personalized, anxiosomatic and dysphoric network guided accelerated intermittent-theta burst (iTBS) using dense functional Magnetic Resonance Imaging (fMRI) sampling in participants with treatment-resistant depression (TRD) and moderate/high levels of anxiety.
Interventions
Magpro X100, Axilium Cobot, Localite Camera
Sponsors
National University Hospital, Singapore
National University of 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 70 Years
Healthy volunteers
No
Inclusion criteria
* Male/female aged 21-70 * Diagnosis of MDD as validated by MINI * Non-response to adequate trial (4 weeks) of at least two MDD medication as verified by the study clinician * BDI score of 20 or above; BAI score of 16 or above * Able to give informed consent * Able to understand English
Exclusion criteria
* DSM-5 psychotic disorder * Drug or alcohol abuse or dependence (preceding 3 months) * Rapid clinical response required, e.g., high suicide risk * Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy * Metal in the cranium, skull defects, pacemaker, cochlear implant, medication pump or other electronic device * Pregnancy * Unsuitable for MRI * With recent TMS or ECT treatment in past 3 months * Multiple stimulant medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rank- Transformed Ratio of Beck Depression Inventory (BDI) to Beck Anxiety Inventory (BAI) change | Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period. | The primary outcome will be the rank-transformed ratio of BDI change to BAI change (e.g. A patient has a 50% reduction in BDI and a 25% reduction in BAI, giving a BDI:BAI ratio of 50% ÷ 25% = 2.0. Another patient has a 40% reduction in BDI and a 25% reduction in BAI, giving a BDI:BAI ratio of 40% ÷ 25% = 1.6. Higher ratios indicate a relatively greater improvement in depression compared with anxiety within each patient. This ratio is then ranked across all patients.). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inventory of Depression and Anxiety Symptoms-II (IDAS-II) | Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period. | IDAS-II is an ordinal self-report scale measuring depression, anxiety, and bipolar symtpoms ranging from 99-495. Higher scores mean worse outcome. |
| Penn State Worry Questionnaire (PSWQ) | Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period. | PSWQ is an ordinal self-report scale measuring pathological worry ranging from 16-80. Scores depend on whether the item is worded positively or negatively. |
| Interaction between TMS target and change in BDI and BAI | Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period. | The investigators will test interactions between TMS Target and change in BDI and BAI (including baseline and weekly outcomes over one month) separately using repeated measures linear mixed effects models. |
Countries
Singapore
Contacts
CONTACTPhern Chern Tor, MBBS
Outcome results
None listed