Accelerated theta burst stimulation for older adults with treatment-resistant depression

Effects of Accelerated Bilateral Sequential Theta Burst Stimulation on Dual-task Cost, Depression, Cognition and Other Outcomes in Older Adults With Treatment-resistant Depression: A Randomized, Double-blind, Sham-controlled Trial

This study is testing a new brain stimulation treatment to see if it can help older adults with depression who haven't found relief from other medications.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Ontario Shores Centre for Mental Health Sciences (other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT06323486 on ClinicalTrials.gov

What this trial studies

The CogniTReaD study is a pilot clinical trial designed to evaluate the effects of accelerated bilateral sequential theta burst stimulation (absTBS) compared to a sham treatment in older adults suffering from treatment-resistant depression (TRD). This double-blinded, randomized controlled trial will assess various outcomes including mood, cognitive functions, anxiety levels, quality of life, and physical performance over a treatment period. Participants aged 50 and older, who have not responded to at least two antidepressant medications, will be recruited to receive either the active treatment or the sham intervention in a specific sequence. The study aims to determine the efficacy and safety of absTBS in improving symptoms of depression and cognitive function while monitoring for any adverse effects.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 50 years or older who have a confirmed diagnosis of treatment-resistant depression and have not responded to multiple antidepressant treatments.

Not a fit: Patients with active suicidal ideation or those who do not meet the criteria for treatment-resistant depression may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for older adults with treatment-resistant depression, potentially improving their mood and cognitive functions.

How similar studies have performed: While the approach of using theta burst stimulation is relatively novel, similar studies have shown promising results in treating depression with transcranial magnetic stimulation techniques.

Eligibility criteria

Inclusion Criteria

1. Aged 50 years or older;
2. Mini International Neuropsychiatric Interview (MINI)-confirmed diagnosis of a non-psychotic major depressive disorder;
3. Currently in a major depressive episode with a score on HAMD-17 of 17 or more;
4. Insufficient response (i.e., failure to achieve remission) to at least two appropriate courses of antidepressant medications during the current depressive episode (i.e., meeting the criteria for TRD);
5. Participants taking or not taking any psychotropic medication/s. If the eligible participant is on any psychotropic medications, the participant should have taken the medication/s at a stable dose for at least 1 week before the start of study intervention treatment and be willing to remain on a stable dose throughout the study follow-up;
6. Passing the TMS safety screen; and
7. Those who have the capacity to provide consent and who voluntary consent to participate in the study.

Exclusion Criteria

1. Those with MINI-confirmed active substance use disorder within the last 3 months;
2. Those with lifetime MINI-confirmed diagnosis of bipolar I disorder, delusional disorder, schizophrenia, schizoaffective disorder, or schizophreniform disorder;
3. Those with major unstable medical comorbidities (i.e., rapidly deteriorating medical/neurological conditions that poses a significant risk to a person's life);
4. Those with a diagnosis of dementia confirmed using the Global Clinical Dementia Rating (CDR) with a score greater than or equal to 1.
5. Those with significant neurological conditions, such as those with any disease process associated with increased intracranial pressure, space-occupying intracranial lesion, history of epilepsy/seizure except those induced by ECT, or febrile seizure of infancy or a single occurrence of seizure associated with a known drug, cerebral aneurysm, or major head trauma resulting to loss of consciousness more than 5 minutes;
6. Those with cardiac pacemaker or implanted mediation pump;
7. Those with intracranial implants/hardwares, including but not limited to aneurysm clips, shunts, stimulators, cochlear implants, electrodes, or any other metal material inside or near the head (excluding the mouth) that cannot be safely removed;
8. Those who are taking more than 2 mg of Lorazepam daily (or equivalent) or taking any dose of an anticonvulsant that may potentially hamper rTMS efficacy;
9. Those who are unable to express and understand using the English language; and
10. Individuals who are pregnant or who are likely pregnant.

Where this trial is running

Toronto, Ontario

• Ontario Shores Centre for Mental Health Sciences — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Amer M. Burhan, MBChB, MSc — Ontario Shores Centre for Mental Health Sciences and University of Toronto
• Study coordinator: Amer M. Burhan, MBChB, MSc

Conditions: Depressive Disorder, Treatment-Resistant, Treatment-resistant depression, Accelerated bilateral sequential theta burst stimulation, Repetitive transcranial magnetic stimulation, Motoric-cognitive risk syndrome, Randomized controlled trial, Brain stimulation