Clinical trial NCT04384965: Accelerated iTBS for Depressed Patients During the COVID-19 Pandemic
Official title: A Novel and Practical Accelerated Intermittent Theta Burst Protocol as a Substitute for Depressed Patients Needing Electroconvulsive Therapy During the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: depression
transcranial magnetic stimulation
treatment resistance
theta burst stimulation
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24)
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary outcomes:
measure: Change in HRSD-24
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Response on HRSD-24
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Remission on Patient Health Questionnaire (PHQ-9)
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Response on PHQ-9
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Change in PHQ-9
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Remission on General Anxiety Disorder 7 item (GAD-7)
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Response on GAD-7
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Change in GAD-7
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Remission on Beck Depression Inventory (BDI-II)
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Response on BDI-II
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Change on BDI-II
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Remission on Beck Scale for Suicidal Ideation (SSI)
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Change on SSI
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Change in WHO Disability Assessment Schedule (WHODAS)
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Proportion of Patients Maintaining Response During Relapse Prevention
timeFrame: 24 weeks (Tapering and Relapse prevention phase)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: CAMH
state: Ontario
Study officials:
affiliation: CAMH
name: Daniel Blumberger, MD
role: PRINCIPAL_INVESTIGATOR
References: