Bipolar Disorder Trial, Recruiting NCT07108257 Sponsor: Sunnybrook Health Sciences Centre Condition: Bipolar Disorder
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Bipolar Disorder Trial, Recruiting

NCT07108257
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 18 and 65 years old (inclusive).
  • You are willing and able to give your consent to take part and can attend all required study visits, as agreed by both a psychiatrist and a surgeon involved in the study.
  • You have been diagnosed with Bipolar Disorder Type 1 or Type 2 according to standard medical guidelines (DSM-5).
  • When you are in a depressive episode, your depression scores at least 20 on a standard rating scale called the Hamilton Depression Rating Scale, and you have been experiencing major depression for at least 2 weeks at the time of that assessment.
  • Your bipolar depression has not responded well enough to treatment — specifically, you have tried at least two single medications, or at least one single medication plus a combination treatment, and each treatment was tried for at least 4 weeks.
  • You are able to understand the study information and make your own medical decisions.

Who may not be able to join:

  • You have an unstable heart condition, such as unstable chest pain, a heart attack in the last 6 months, heart failure requiring certain medications, use of heart rhythm medications, or very high blood pressure that is hard to control.
  • You have metal implants in your body (such as a pacemaker) or other reasons why you cannot safely have an MRI scan, or your body size may be a limitation (confirm with trial site).
  • Your blood tests show problems with bleeding or blood clotting, such as a low platelet count or abnormal clotting levels.
  • You have a history of stroke or bleeding in the brain, or a stroke within the past 6 months.
  • You have sleep apnea that is not being treated or controlled.
  • You have taken blood-thinning medications (such as warfarin or aspirin) within one week before the procedure, or certain other medications that increase bleeding risk within one month before the procedure.
  • You are unable or unwilling to lie still on your back for an extended period of time during treatment.
  • You have taken part in another clinical trial within the last 30 days.
  • You are unable to communicate with the research team.
  • You have significant problems with memory or thinking ability.
  • You have a history of psychosis (losing touch with reality) based on a clinical evaluation.
  • You are currently in a catatonic or psychotic state, or you are actively thinking about suicide at the time of evaluation.
  • A brain tumor has been found, either previously known or discovered on a pre-treatment MRI scan.
  • You are currently pregnant or breastfeeding.
  • You have had a problem with alcohol or drug misuse or dependence within the past 6 months.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: (416)-480-6954

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
25 June 2025
Est. completion
16 September 2027

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Safety of Magnetic Resonance-guided Focused Ultrasound for patients with Treatment-Resistant Bipolar Disorder

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov