Who is eligible for clinical trial NCT06370988?

Participants must meet the protocol's inclusion criteria for Bipolar Depression. The stated age range is 18 Years to 65 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06370988 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

Theta-Burst Stimulation for Bipolar Depression (NCT06370988)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Centre for Addiction and Mental Health

🩺 Plain-English Summary (8th-Grade Level)

The purpose of this trial is to determine if intermittent theta-burst stimulation (iTBS) can reduce the symptoms of depression in treatment-resistant bipolar disorder. To do this, some of the participants in this study will receive treatment with active iTBS stimulation, while others will receive sham iTBS stimulation. Participants will come for 30 days of either active iTBS or sham iTBS, with a 6-week follow-up period. Symptoms of depression (for determining treatment efficacy) and mania (for determining treatment safety) will be assessed using the 17-item Hamilton Rating Scale for Depression (HRSD-17) and the Young Mania Rating Scale (YMRS) every five treatments during the treatment course, and at 1 week and 6 week after treatment completion.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (16 items).

Location: University Health Network — Toronto, Ontario

Age range: 18 Years to 65 Years

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

Exclusion Criteria An individual who meets any of the following criteria will be excluded from participation in this clinical trial:
have a history of MINI diagnosis of a substance use disorder (other than nicotine and/or caffeine) within the last 3 months;
have a concomitant major unstable medical illness;
have active suicidal intent (assessed during HRSD-17 Item 3 and SSRS as imminent intent to act on specific plan, confirmed by psychiatric staff);
are pregnant or intend to get pregnant during the study;
have a lifetime MINI diagnosis of schizophrenia or schizoaffective disorder;
have psychotic symptoms within the current episode;
have a MINI anxiety disorder, trauma-related disorder, obsessive compulsive disorder, or personality disorder assessed by a study investigator to be primary and/or causing greater impairment than BD-DE;
failure of an adequate acute course of ECT as defined by ATHF-SF during the current episode;
have received any rTMS before due to potential to compromise blinding of treatment allocation;
have any clinically significant neurological disorder (e.g., recent major cerebrovascular accident), or any history of seizure except those therapeutically induced by ECT or with clear precipitant (e.g., febrile seizure of childhood, alcohol withdrawal, etc.);
have any intracranial implant (e.g., aneurysm clips, shunts, stimulators,) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

University Health Network — Toronto, Ontario
Centre for Addiction and Mental Health — Toronto, Ontario

📞 Contact the Study Coordinator

Phone: (416) 535-8501

Email: Elizabeth.Clancy@camh.ca

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗