RecruitingNot ApplicableNCT06370988

Theta-Burst Stimulation for Bipolar Depression

Sponsor

Centre for Addiction and Mental Health

Enrollment

124 participants

Start Date

May 15, 2024

Study Type

INTERVENTIONAL

Conditions

Bipolar Disorder Bipolar Depression Treatment- Resistant Bipolar Disorder Type 2 Bipolar Disorder

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a type of repetitive brain stimulation called Theta-Burst Stimulation (TBS) — a non-invasive procedure that uses magnetic pulses on the scalp — can help relieve depression in people with bipolar disorder who haven't responded well to medications. **You may be eligible if...** - You are between 18 and 65 years old - You have bipolar disorder (Type I or II) currently in a depressive episode - You have tried at least one adequate medication for bipolar depression without success, or couldn't tolerate the medication - Your depression is moderately severe (PHQ-9 score of 15 or higher) - You are not currently in a manic or mixed episode **You may NOT be eligible if...** - You have metal implants in your head or a history of seizures (contraindications to brain stimulation) - You are pregnant - You have had recent changes to your mood stabilizer medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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