Bipolar DepressionTRIBENCT06370988
Theta-Burst Stimulation for Bipolar Depression
A study testing iTBS Stimulation in people with Bipolar Depression and Bipolar Disorder, run by Centre for Addiction and Mental Health at 2 sites in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Depression, Bipolar Disorder, Treatment- Resistant Bipolar Disorder
- What is being tested?
- iTBS Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 2 sitesCanada
- Study dates
- 15 May 2024to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant must meet all of the inclusion criteria to eligible for this clinical trial:
- Must be deemed to have capacity to provide informed consent;
- 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);
- Age 18-65;
- 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
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- moderately severe depression with a score ≥ 15 on the PHQ-9;44
- not currently experiencing a mixed or manic episode (YMRS ≤10);
- no increase or initiation of psychotropic medication with intention of treating depressive symptoms in the 4 weeks prior to screening. This excludes targeted treatment of insomnia with trazodone, melatonin, low-dose doxepin [3-6mg], low-dose benzodiazepines [≤2mg lorazepam daily equivalent], non-benzodiazepine benzodiazepine receptor agonists, or orexin antagonists;
- able to adhere to the treatment schedule;
- pass the TMS adult safety screening questionnaire.45
Who cannot join
- 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;
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- 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;
- are participating in psychotherapy for less than 3 months. Patients will be permitted if they have been in stable treatment for at least 3 months prior to study entry, with no anticipated change in the frequency of therapeutic sessions, or focus of therapeutic sessions over the duration of the study;
- are currently taking lorazepam >2 mg daily (or equivalent) due to the potential to limit rTMS efficacy;
- are currently taking any dose of an anticonvulsant due to the potential to limit rTMS efficacy. If anticonvulsants have been discontinued prior to screening, at least 5 half-lives have elapsed until screening to allow sufficient drug clearance;
- have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5T 2S8
Eileen Lam, 437-553-0367, Eileen.lam@uhn.ca
Daphne Voineskos, M.D., Ph.D
- Recruiting
Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H4
Hannah Taalman, 416-535-8501, hannah.taalman@camh.ca
Tyler Kaster, M.D., Ph.D
About this study
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.
- Conditions
- Bipolar Depression, Bipolar Disorder, Treatment- Resistant Bipolar Disorder, Type 2 Bipolar Disorder
- Being tested
- iTBS Stimulation, Sham iTBS Stimulation
- Keywords
- Transcranial Magnetic Stimulation, Repetitive Transcranial Magnetic Stimulation, rTMS, iTBS
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTBS StimulationDevice
Fluid-Cooled B70 A/P Coil with either Magventure X100 or R30
Sham iTBS StimulationDevice
Fluid-Cooled B70 A/P Coil with either Magventure X100 or R30
| Study group | Role | What they receive |
|---|---|---|
| Sham iTBS Stimulation | Sham comparator | Administered once daily over 30 days, using a sham coil that reproduces auditory and tactile sensations of stimulation and has an identical external appearance. Each session will deliver 600 pulses of sham iTBS in triplet 50Hz bursts, repeated at 5Hz 2s on 8s off for a total time of ~3 minutes, 9 seconds at a target intensity of 120% of the subject's resting motor threshold. Receives: Device: Sham iTBS Stimulation |
| Active iTBS Stimulation | Experimental | Administered once daily over 30 days. Each session will deliver 600 pulses of active iTBS in triplet 50Hz bursts, repeated at 5Hz 2s on 8s off for a total time of ~3 minutes, 9 seconds at a target intensity of 120% of the subject's resting motor threshold. Receives: Device: iTBS Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17)
Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17), ITT, 6 weeks (completion of treatment phase (30 txs)). The main effect of interest is the interaction term between time since starting treatment and treatment allocation. This analytic approach incorporates longitudinal depressive symptom assessments throughout the trial rather solely at treatment completion.
Measured: From enrollment to 6 weeks post-treatment
Secondary outcomes (1)
Symptoms of Mania
Safety of rTMS in BD-DE with respect to symptoms of mania, Young Mania Rating Scale (YMRS), Safety Outcomes, 6 weeks (completion of treatment phase (30 txs)). The main effect of interest is the interaction term between time since starting treatment and treatment allocation. This analytic approach incorporates longitudinal depressive symptom assessments throughout the trial rather solely at treatment completion.
Measured: From enrollment to 6 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start15 May 2024
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial will use a multi-centre randomized controlled trial for individuals with treatment-resistant Bipolar Depression comparing iTBS applied to the left DLPFC with sham treatment and examining differences in efficacy and safety outcomes between groups over 6 weeks of treatment.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Principal investigator, Tyler Kaster, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370988
- Sponsor's protocol ID
- 4343
- Acronym
- TRIBE
- Status last verified
- Oct 2026
- First submitted
- 15 Apr 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theta-Burst Stimulation for Bipolar Depression
- ClinicalTrials.gov ID
- NCT06370988
- Acronym / sponsor ID
- TRIBE / 4343
- Conditions
- Bipolar Depression, Bipolar Disorder, Treatment- Resistant Bipolar Disorder, Type 2 Bipolar Disorder
- Keywords
- Transcranial Magnetic Stimulation, Repetitive Transcranial Magnetic Stimulation, rTMS, iTBS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- 15 May 2024 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This trial will use a multi-centre randomized controlled trial for individuals with treatment-resistant Bipolar Depression comparing iTBS applied to the left DLPFC with sham treatment and examining differences in efficacy and safety outcomes between groups over 6 weeks of treatment.
| Arm | Type | Receives |
|---|---|---|
| Sham iTBS Stimulation | Sham comparator | Device: Sham iTBS StimulationAdministered once daily over 30 days, using a sham coil that reproduces auditory and tactile sensations of stimulation and has an identical external appearance. Each session will deliver 600 pulses of sham iTBS in triplet 50Hz bursts, repeated at 5Hz 2s on 8s off for a total time of ~3 minutes, 9 seconds at a target intensity of 120% of the subject's resting motor threshold. |
| Active iTBS Stimulation | Experimental | Device: iTBS StimulationAdministered once daily over 30 days. Each session will deliver 600 pulses of active iTBS in triplet 50Hz bursts, repeated at 5Hz 2s on 8s off for a total time of ~3 minutes, 9 seconds at a target intensity of 120% of the subject's resting motor threshold. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The participant must meet all of the inclusion criteria to eligible for this clinical trial:
- Must be deemed to have capacity to provide informed consent;
- 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);
- Age 18-65;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iTBS StimulationFluid-Cooled B70 A/P Coil with either Magventure X100 or R30 | Device | Active iTBS Stimulation |
| Sham iTBS StimulationFluid-Cooled B70 A/P Coil with either Magventure X100 or R30 | Device | Sham iTBS Stimulation |
Primary outcome
Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17)
Time frame: From enrollment to 6 weeks post-treatment
Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17), ITT, 6 weeks (completion of treatment phase (30 txs)). The main effect of interest is the interaction term between time since starting treatment and treatment allocation. This analytic approach incorporates longitudinal depressive symptom assessments throughout the trial rather solely at treatment completion.
1 secondary outcome
Symptoms of Mania
Time frame: From enrollment to 6 weeks post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Bipolar Depression
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iTBS Stimulation in people with Bipolar Depression and Bipolar Disorder, run by Centre for Addiction and Mental Health at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah Taalman (416-535-8501, Hannah.Taalman@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17) (time frame: From enrollment to 6 weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.