Accelerated iTBS for Depressed Patients During the COVID-19 Pandemic

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04384965
• Other study ID #: 059/2020
• Status: Completed
• Phase: N/A
• Start date: May 12, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: February 2024
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: November 1, 2022
• Est. primary completion date: May 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• MagPro X100 Stimulator, B70 Fluid-Cooled Coil
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.

Locations

Country	Name	City	State
Canada	CAMH	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24)	Less than or equal to 10	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Change in HRSD-24	changes in scores	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Response on HRSD-24	50% Reduction in score	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Remission on Patient Health Questionnaire (PHQ-9)	Less than or equal to 4	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Response on PHQ-9	50% Reduction in score	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Change in PHQ-9	changes in scores	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Remission on General Anxiety Disorder 7 item (GAD-7)	Less than or equal to 4	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Response on GAD-7	50% Reduction in score	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Change in GAD-7	changes in scores	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Remission on Beck Depression Inventory (BDI-II)	Less than or equal to 12	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Response on BDI-II	50% Reduction in Score	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Change on BDI-II	changes in scores	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Remission on Beck Scale for Suicidal Ideation (SSI)	Score of 0	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Change on SSI	changes in scores	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Change in WHO Disability Assessment Schedule (WHODAS)	changes in scores	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Proportion of Patients Maintaining Response During Relapse Prevention	Includes number of treatment days needed and number going on to receive ECT	24 weeks (Tapering and Relapse prevention phase)