← Back to Search

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
Must be on a stable medication regimen requiring at least one mood stabilizer
Depression severity as represented by scoring at least 20 on MADRS
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check β€œYes” for the criteria below
Select...
I am on a consistent medication plan that includes at least one mood stabilizer.
Select...
My depression is severe, scoring 20 or more on a scale.
Select...
I have been diagnosed with bipolar depression.
Select...
I am between 18 and 70 years old.
Select...
I have depression that hasn't improved after trying at least 2 different antidepressants.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

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.

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,114 Previous Clinical Trials
1,519,820 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
1,991 Previous Clinical Trials
42,875,720 Total Patients Enrolled
5 Trials studying Bipolar Disorder
665 Patients Enrolled for Bipolar Disorder

Media Library

Accelerated Theta Burst Stimulation (Repetitive Transcranial Magnetic Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05393648 β€” N/A
Bipolar Disorder Research Study Groups: Sham iTBS, Active iTBS
Bipolar Disorder Clinical Trial 2023: Accelerated Theta Burst Stimulation Highlights & Side Effects. Trial Name: NCT05393648 β€” N/A
Accelerated Theta Burst Stimulation (Repetitive Transcranial Magnetic Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05393648 β€” N/A

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:
  1. UCSD Interventional Psychiatry: < 48 hours
Average response time
  • < 2 Days
~19 spots leftby Dec 2024