RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: iTBS Stimulation for Bipolar Depression

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.

Official registry: https://clinicaltrials.gov/study/NCT06370988 · Centre for Addiction and Mental Health · enrollment listed as 124

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

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 iTBS Stimulation, or Sham iTBS Stimulation. The registry lists allocation as randomized. 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.

They plan to enroll about 124 people at 2 sites. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

Theta-Burst Stimulation for Bipolar Depression

Interventions: iTBS Stimulation, Sham iTBS Stimulation

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 65 Years
The participant must meet all of the who can join to eligible for this clinical trial:
Must be an outpatient
Have a DSM 5 diagnosis of bipolar disorder (type I or II), current episode depressed confirmed by Mini-International Neuropsychiatric Interview version 7.0.2 (MINI);
failure to achieve a clinical response to ≥1 adequate treatment trial for bipolar depression based on the Antidepressant Treatment History Form - Short Form (ATHF-SF) OR unable to tolerate at least 2 separate inadequate treatment trials for bipolar depression;43
moderately severe depression with a score ≥ 15 on the PHQ-9;44
not currently experiencing a mixed or manic episode (YMRS ≤10);
able to adhere to the treatment schedule;

Who the registry excludes

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;

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

University Health Network — Toronto, Ontario, Canada (recruiting)
Centre for Addiction and Mental Health — Toronto, Ontario, Canada (recruiting)

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FAQ about this NCT record

Is NCT06370988 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 NCT06370988?

Not a traditional drug phase. 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 NCT06370988?

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