Major Depressive Disorder
Conditions
Keywords
depression, transcranial magnetic stimulation, treatment resistance, theta burst stimulation
Brief summary
The current study aims to assess the feasibility, acceptance and clinical outcomes of a practical high-dose aiTBS protocol, including tapering treatments and symptom-based relapse prevention treatments, in patients with unipolar depression previously responsive to ECT and patients needing urgent treatment due to symptom severity during the COVID-19 pandemic.
Interventions
Treatment will occur 8 times per treatment day (50 min pause between treatments). Each treatment session will consist of a single iTBS treatment, delivering 600 pulses of iTBS (bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz, with a duty cycle of 2 seconds on, 8 seconds off, over 60 cycles / \ 3 minutes) at a target of 110% of the subject's resting MT.
Sponsors
Centre for Addiction and Mental Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have unipolar depressive episode based on the MINI with or without psychotic symptoms * Have previous response to ECT or high symptom severity warranting acute ECT in the opinion of a consultant brain stimulation psychiatrist * Are over the age of 18 * Pass the TMS adult safety screening (TASS) questionnaire * Are voluntary and competent to consent to treatment
Exclusion criteria
* Have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of substance dependence or abuse within the last 1 month * Have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump * Have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder * Have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT or a febrile seizure of infancy or single seizure related to a known drug related event, cerebral aneurysm, or significant head trauma with loss of consciousness for greater than 5 minutes * have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed * currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy * Lack of response to accelerated course of iTBS or rTMS in the past
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24) | Up to 10 days (From screening/baseline to end of the acute treatment) | Less than or equal to 10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response on HRSD-24 | Up to 10 days (From screening/baseline to end of the acute treatment) | 50% Reduction in score |
| Remission on Patient Health Questionnaire (PHQ-9) | Up to 10 days (From screening/baseline to end of the acute treatment) | Less than or equal to 4 |
| Response on PHQ-9 | Up to 10 days (From screening/baseline to end of the acute treatment) | 50% Reduction in score |
| Change in PHQ-9 | Up to 10 days (From screening/baseline to end of the acute treatment) | changes in scores |
| Remission on General Anxiety Disorder 7 item (GAD-7) | Up to 10 days (From screening/baseline to end of the acute treatment) | Less than or equal to 4 |
| Response on GAD-7 | Up to 10 days (From screening/baseline to end of the acute treatment) | 50% Reduction in score |
| Change in GAD-7 | Up to 10 days (From screening/baseline to end of the acute treatment) | changes in scores |
| Change in HRSD-24 | Up to 10 days (From screening/baseline to end of the acute treatment) | changes in scores |
| Response on BDI-II | Up to 10 days (From screening/baseline to end of the acute treatment) | 50% Reduction in Score |
| Change on BDI-II | Up to 10 days (From screening/baseline to end of the acute treatment) | changes in scores |
| Remission on Beck Scale for Suicidal Ideation (SSI) | Up to 10 days (From screening/baseline to end of the acute treatment) | Score of 0 |
| Change on SSI | Up to 10 days (From screening/baseline to end of the acute treatment) | changes in scores |
| Change in WHO Disability Assessment Schedule (WHODAS) | Up to 10 days (From screening/baseline to end of the acute treatment) | changes in scores |
| Proportion of Patients Maintaining Response During Relapse Prevention | 24 weeks (Tapering and Relapse prevention phase) | Includes number of treatment days needed and number going on to receive ECT |
| Remission on Beck Depression Inventory (BDI-II) | Up to 10 days (From screening/baseline to end of the acute treatment) | Less than or equal to 12 |
Countries
Canada
Outcome results
None listed