Conventional Bilateral rTMS vs. Bilateral Theta Burst Stimulation for Late-Life Depression

Major Depression Clinical Trial

Official title:

Conventional Bilateral rTMS vs. Bilateral Theta Burst Stimulation for Late-Life Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02998580
• Other study ID #: 076-2016
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: April 24, 2020

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

This trial will compare conventional sequential bilateral rTMS to a bilateral theta burst stimulation protocol. The right and left dorsolateral prefrontal cortices will be the site of stimulation in both treatment conditions. The site of stimulation will be targeted using MRI co-registration. The study seeks to determine if the bilateral theta burst protocol has similar effectiveness to the conventional bilateral rTMS protocol in treating major depression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: April 24, 2020
• Est. primary completion date: April 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• are an outpatient

• are =60 years old

• have a Mini-International Neuropsychiatric Interview (MINI 6.0)67 confirmed diagnosis of MDD, with a current MDE

• have failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of > 3 in the current episode or have failed to tolerate two separate trials of an antidepressant

• have a score > 17 on the MADRS

• have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening

• have normal electrolytes, hemoglobin and thyroid functioning based on pre-study blood work

• Pass the TMS adult safety screening (TASS) questionnaire

• Are able to have an MRI

Exclusion Criteria:

• have a history of substance dependence or abuse within the last 3 months

• have a concomitant major unstable medical illness determined by one of the study physicians

• have active suicidal intent

• have a lifetime MINI diagnosis of bipolar I or II disorder, or primary psychotic disorder

• have current psychotic symptoms

• have a diagnosis of obsessive compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia, assessed by a study investigator to be primary. One of these comorbidities will not be exclusionary if they are not deemed to be primary.

• have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD

• have presumed or probable dementia or clinical evidence of dementia as assessed by a Short Blessed Test score of greater than 10.

• did not respond to a course of ECT in the current depressive episode

• have received rTMS in the current episode, patients who have had rTMS in a previous episode would be eligible

• have a history of a primary seizure disorder or a seizure associated with an intracranial lesion.

• 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

• have a implanted electronic device that is currently function such as a defibrillator

• currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant

• if participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study

• non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Major Depression

Intervention

Device:
• LFR followed by HFL
Magventure Cool B70 Coil with RX100 Stimulator
• cTBS followed by iTBS
Magventure Cool B70 Coil with RX100 Stimulator

Locations

Country	Name	City	State
Canada	CAMH	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change on the Montgomery Asberg Depression Rating Scale (MADRS)	Change from baseline to week 4 or 6 endpoint	After 4 or 6 weeks
Secondary	Remission on the MADRS	Score less than or equal to 10	After 4 or 6 weeks

External Links

•   Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collab