Actively Recruiting
Theta-Burst Stimulation for Bipolar Depression
Led by Centre for Addiction and Mental Health · Updated on 2026-03-18
124
Participants Needed
2
Research Sites
258 weeks
Total Duration
On this page
Sponsors
C
Centre for Addiction and Mental Health
Lead Sponsor
U
University Health Network, Toronto
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Theta-Burst Stimulation for Bipolar Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have the ability to provide informed consent
- Must be an outpatient
- Diagnosed with bipolar disorder type I or II, current episode depressed, confirmed by MINI interview
- Aged between 18 and 65 years
- Have failed to respond to at least one adequate treatment trial for bipolar depression or unable to tolerate at least two separate treatment trials
- Have moderately severe depression with a PHQ-9 score of 15 or higher
- Not currently in a mixed or manic episode (YMRS score 10 or less)
- No changes or new psychotropic medications intended to treat depression in the 4 weeks before screening, except certain sleep aids
- Able to adhere to the treatment schedule
- Must pass the TMS adult safety screening questionnaire
You will not qualify if you...
- Substance use disorder (other than nicotine or caffeine) in the last 3 months
- Major unstable medical illness
- Active suicidal intent confirmed by psychiatric staff
- Pregnant or planning pregnancy during the study
- Lifetime diagnosis of schizophrenia or schizoaffective disorder
- Psychotic symptoms in the current episode
- Primary anxiety, trauma-related, OCD, or personality disorder causing greater impairment than bipolar depression
- Failed adequate course of electroconvulsive therapy during the current episode
- Previous treatment with rTMS
- Significant neurological disorders or history of seizures except certain exceptions
- Presence of intracranial implants or metal near the head that cannot be safely removed
- Psychotherapy treatment less than 3 months or unstable therapy
- Taking lorazepam over 2 mg daily equivalent
- Currently taking any anticonvulsant medication unless discontinued with sufficient clearance
- Significant sensory impairments preventing cooperation with interviews
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University Health Network
Toronto, Ontario, Canada, M5T 2S8
Actively Recruiting
2
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M6J 1H4
Actively Recruiting
Research Team
E
Elizabeth Clancy
CONTACT
M
Mawahib Semeralul
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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