Accelerated Bilateral Sequential Theta Burst Stimulation in Older Adults With Treatment-resistant Depression

Launched by ONTARIO SHORES CENTRE FOR MENTAL HEALTH SCIENCES · Mar 14, 2024

Keywords

ClinConnect Summary

The CogniTReaD study is a research trial that aims to find out if a new treatment called accelerated bilateral sequential theta burst stimulation (absTBS) can help older adults who are struggling with depression that hasn't improved with standard medications. In this study, participants aged 50 and older who have been diagnosed with major depressive disorder will receive either the active treatment or a placebo (an inactive treatment) without knowing which one they are getting. The researchers will look at how this treatment affects mood, cognitive abilities (like thinking and remembering), anxiety, quality of life, and physical performance, as well as monitor any side effects.

To be eligible to participate, individuals must be at least 50 years old and have experienced a significant level of depression that hasn't responded to at least two different antidepressant medications. They should not have certain severe mental health conditions, unstable medical issues, or specific neurological problems. Participants will also need to be able to understand and provide consent for the study. This trial is a chance for those who have not found relief from traditional treatments to explore a new option, and it could pave the way for larger studies in the future if successful.

Gender

ALL

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.