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Repetitive Transcranial Magnetic Stimulation
rTMS for Bipolar Disorder
N/A
Waitlist Available
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is being conducted to test the effects of high-dose, spaced theta-burst transcranial magnetic stimulation (TMS) on depressive symptoms in patients with bipolar disorder (BPD) who have failed to respond to prior treatments. The null hypothesis is that there will be no difference in reductions in depressive symptoms between the active TMS group and the sham group. The alternative hypothesis is that, compared with sham, active TMS will result in a greater reduction in depressive symptoms. The study will also aim to identify biomarkers in cortical regions associated with BPD and to formulate a statistical model that may be able to predict BPD remission after
Who is the study for?
This trial is for adults aged 18-70 with bipolar depression who haven't improved after at least two different treatments. Participants must score at least 20 on the MADRS depression scale, meet DSM 5 criteria for Bipolar I or II, be able to consent, and pass a safety screen for TMS. They should be on stable medication including one mood stabilizer.Check my eligibility
What is being tested?
The study tests if high dose spaced theta-burst rTMS can significantly reduce depressive symptoms in bipolar disorder compared to sham treatment over five days. It also aims to identify biomarkers in the brain that could predict remission from bipolar depression after treatment.See study design
What are the potential side effects?
While not explicitly stated here, common side effects of rTMS may include headache, scalp discomfort during stimulation, lightheadedness, and rare risk of seizure; however individual experiences may vary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of Biomarkers
Change in Hamilton Rating Scale for Depression (HRSD-17) Scores
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active iTBSExperimental Treatment1 Intervention
Patients will receive unilateral accelerated theta-burst stimulation to the left dorsal lateral prefrontal cortex for 5 consecutive days, with a total of 10 hours a day. Treatment will be 10min with 50min of breaks in between the 10 sessions.
Group II: Sham iTBSPlacebo Group1 Intervention
Patients will receive sham unilateral accelerated theta-burst stimulation to the left dorsal lateral prefrontal cortex for 5 consecutive days, with a total of 10 hours a day. Treatment will be 10min with 50min of breaks in between the 10 sessions.
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Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,126 Previous Clinical Trials
1,552,931 Total Patients Enrolled
12 Trials studying Bipolar Disorder
2,013 Patients Enrolled for Bipolar Disorder
Milken InstituteOTHER
7 Previous Clinical Trials
227 Total Patients Enrolled
6 Trials studying Bipolar Disorder
221 Patients Enrolled for Bipolar Disorder
University of PennsylvaniaOTHER
2,009 Previous Clinical Trials
42,894,593 Total Patients Enrolled
5 Trials studying Bipolar Disorder
667 Patients Enrolled for Bipolar Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a severe illness like widespread cancer or kidney failure.I have depression that hasn't improved after trying at least two different antidepressants.I have been diagnosed with bipolar depression.I am on a consistent medication plan that includes at least one mood stabilizer.My depression is severe, scoring 20 or more on a scale.I do not have depression as my main health issue.I don't have implants or conditions that make TMS or MRI unsafe for me.My gender does not affect my eligibility.I have been diagnosed with bipolar depression.I have depression that hasn't improved after trying at least 2 different antidepressants.I am between 18 and 70 years old.I am on a consistent medication plan that includes at least one mood stabilizer.
Research Study Groups:
This trial has the following groups:- Group 1: Sham iTBS
- Group 2: Active iTBS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Virginia
How old are they?
18 - 65
What site did they apply to?
UCSD Interventional Psychiatry
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I have Bipolar Disorder and have been experiencing depression for approximately 2 1/2 years. I have taken a few antidepressants. Still, I have been depressed. I would love to be in your Clinical Trials so that possibly a new medication will work wonders for me. Plus, I like to contribute to helping others with Bipolar Disorder/Depression.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- UCSD Interventional Psychiatry: < 48 hours
Average response time
- < 2 Days
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