Accelerated Theta Burst Stimulation for Manic Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UCSD Interventional Psychiatry, San Diego, CA
Manic Disorder+1 More
Accelerated Theta Burst Stimulation - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The research study is being conducted to test whether using high dose spaced theta-burst rTMS (a form of repetitive transcranial magnetic stimulation) produces a significant reduction in depressive symptoms compared with sham. This project will recruit patients aged 18-70 with symptoms of bipolar depression (BPD) who have failed (or not shown signs of improvement) after at least two prior treatments. The null hypothesis is that there will be no difference in reductions in depressive symptoms by the end of a five-day treatment period. The alternative hypothesis is that, compared with sham, active TMS will result in a greater reduction in depressive symptoms by the end of the treatment period. To facilitate the development of rTMS protocols there is a need for biomarkers that are sensitive to BPD symptom severity and clinical improvement. Previously in our lab, investigators developed biomarkers suitable for depression trials, and these biomarkers are very likely to show sensitivity to BPD, since they are associated with brain regions and functions associated with BPD. As a secondary aim, the investigators will try to identify biomarkers in cortical region associated with BPD, and formulate a statistical model that may be able to predict BPD remission after the treatment. this study will lead to development of new brain stimulation treatment protocols and biomarkers, will aid in treatment selection, and eventually lead to better clinical outcome for patients suffering from BPD.

Eligible Conditions

  • Manic Disorder
  • Bipolar Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: 6 months

6 months
Assessment of Biomarkers
Change in Hamilton Rating Scale for Depression (HRSD-17) Scores
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Active iTBS
1 of 2
Sham iTBS
1 of 2
Experimental Treatment
Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: Accelerated Theta Burst Stimulation · Has Placebo Group · N/A

Active iTBS
Device
Experimental Group · 1 Intervention: Accelerated Theta Burst Stimulation · Intervention Types: Device
Sham iTBS
Device
PlaceboComparator Group · 1 Intervention: Sham accelerated Theta Burst Stimulation · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
Closest Location: UCSD Interventional Psychiatry · San Diego, CA
Photo of san diego 1Photo of san diego 2Photo of san diego 3
N/AFirst Recorded Clinical Trial
0 TrialsResearching Manic Disorder
0 CompletedClinical Trials

Who is running the clinical trial?

Milken InstituteOTHER
6 Previous Clinical Trials
192 Total Patients Enrolled
University of PennsylvaniaOTHER
1,797 Previous Clinical Trials
36,106,502 Total Patients Enrolled
University of California, San DiegoLead Sponsor
1,007 Previous Clinical Trials
1,793,104 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

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You are able to provide informed consent to participate in the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.