Theta-Burst Stimulation for Bipolar Depression

Not Applicable

Recruiting

• Conditions: Treatment- Resistant Bipolar Disorder; Bipolar Depression; Type 2 Bipolar Disorder; Bipolar Disorder

• Registration Number: NCT06370988
• Lead Sponsor: Centre for Addiction and Mental Health

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-15
• Study First Posted: 2024-04-17
• Study Start: 2024-05-15
• Status Verified: 2024-08
• Last Update Submitted: 2025-06-26
• Last Update Posted: 2025-06-29
• Primary Completion: 2029-05
• Study Completion: 2029-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17)	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.

Secondary Outcome Measures

Name	Time	Method
Symptoms of Mania	From enrollment to 6 weeks post-treatment	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.

Trial Locations

Locations (2)

University Health Network; 🇨🇦 Toronto, Ontario, Canada

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada