Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: MagPro X100/R30 stimulator, Cool-B70 coil for Bipolar Depression Depressed Phase

The purpose of this trial is to conduct an adequately powered clinical trial of once daily LFR for individuals diagnosed with treatment-resistant BD-DE who have not responded to iTBS or sham treatment applied to the left DLPFC. This work will develop the evidence supporting the use of LFR rTMS for individuals with treatment-resistant BD-DE who currently have limited treatment options to alleviate their suffering.

Official registry: https://clinicaltrials.gov/study/NCT06986460 · Tyler Kaster · enrollment listed as 80

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are MagPro X100/R30 stimulator, Cool-B70 coil. The registry lists allocation as na. The purpose of this trial is to conduct an adequately powered clinical trial of once daily LFR for individuals diagnosed with treatment-resistant BD-DE who have not responded to iTBS or sham treatment applied to the left DLPFC.

They plan to enroll about 80 people at 2 sites. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

Low Frequency Right Dorsolateral Pre Frontal Cortical Repetitive TMS for Bipolar Depression

Interventions: MagPro X100/R30 stimulator, Cool-B70 coil

Primary outcome (registry wording): Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Must be an outpatient;
  • older than 18 years;
  • failure to achieve a clinical response within the TRIBE study (CTO#: 4343) defined as ≤50% response from baseline to 6 weeks on the HRSD-17
  • Score ≥10 on PHQ-9 at both (i) the 6 weeks follow-up in the TRIBE trial and (ii) at screening;
  • ≤3 months from completion of the TRIBE study;
  • not currently experiencing a mixed or manic episode (YMRS ≤10);
  • able to adhere to the treatment schedule;

Public study contact (from the registry)

Hannah Taalman

416-535-8501

Hannah.taalman@camh.ca

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

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FAQ about this NCT record

Is NCT06986460 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06986460?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06986460?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary