Individualized Accelerated Intermittent Theta Burst Stimulation (Ind-aiTBS) for Anhedonia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UCSD Interventional Psychiatry, San Diego, CA
Anhedonia+1 More
Individualized Accelerated Intermittent Theta Burst Stimulation (Ind-aiTBS) - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This program of research constitutes a three-arm, randomized, placebo-controlled trial testing noninvasive brain stimulation for the treatment of anhedonic depression. This trial is part of a larger, three-site study that will be conducted at UCSD, Stanford University, and Cornell University, with the overarching goals to compare competing interventions tested at each site and to combine data that will allow for the creation of an end-to-end model of anhedonic depression. By doing this, the investigators hope to gain insight and lead to the development of brain-behavior biomarkers to identify who is best suited for the different treatment options tested at each site. An additional exploratory objective is phenotyping anhedonic depression from the acquired measures. Anhedonic patients recruited at UCSD will be randomized to one of three treatment arms to receive different forms of accelerated intermittent theta burst stimulation (aiTBS),a novel form of repetitive transcranial magnetic stimulation (rTMS) that is an FDA approved treatment for depression. These arms include: individualized accelerated iTBS (Ind-aiTBS),based on both the frequency of brain responses and electric-field (e-field) modeling of brain bioconductivity; standard accelerated iTBS (Std-aiTBS); and accelerated sham iTBS(sham). Treatment will be delivered on an accelerated schedule, over one week. Additional study sessions will occur both before and after treatment to assess for clinical, neurophysiological, and cognitive measures that will allow for both individualization of treatment and detailed assessment of the effects of the different treatment arms.

Eligible Conditions

  • Anhedonia
  • Major Depressive Disorder (MDD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Anhedonia

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: 8 weeks

8 weeks
Assessment of Neuroplasticity
Change in DARS Scores
Change in MADRS Scores
Cross-Sectional TMS-EEG Biomarker
Cross-Sectional fMRI Biomarker
Predictive TMS-EEG Biomarker
Predictive fMRI Biomarker

Trial Safety

Safety Progress

1 of 3

Other trials for Anhedonia

Trial Design

3 Treatment Groups

Standard Accelerated Intermittent Theta Burst Stimulation (Std-aiTBS)
1 of 3
Individualized Accelerated Intermittent Theta Burst Stimulation (Ind-aiTBS)
1 of 3
Sham Accelerated Intermittent Theta Burst Stimulation (sham)
1 of 3
Active Control
Experimental Treatment
Non-Treatment Group

129 Total Participants · 3 Treatment Groups

Primary Treatment: Individualized Accelerated Intermittent Theta Burst Stimulation (Ind-aiTBS) · Has Placebo Group · N/A

Individualized Accelerated Intermittent Theta Burst Stimulation (Ind-aiTBS)
Device
Experimental Group · 1 Intervention: Individualized Accelerated Intermittent Theta Burst Stimulation (Ind-aiTBS) · Intervention Types: Device
Standard Accelerated Intermittent Theta Burst Stimulation (Std-aiTBS)
Device
ActiveComparator Group · 1 Intervention: Standard Accelerated Intermittent Theta Burst Stimulation (Std-aiTBS) · Intervention Types: Device
Sham Accelerated Intermittent Theta Burst Stimulation (sham)
Device
ShamComparator Group · 1 Intervention: Sham Accelerated Intermittent Theta Burst Stimulation (Sham) · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks
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
1 TrialsResearching Anhedonia
0 CompletedClinical Trials

Who is running the clinical trial?

Stanford UniversityOTHER
2,130 Previous Clinical Trials
35,668,781 Total Patients Enrolled
1 Trials studying Anhedonia
65 Patients Enrolled for Anhedonia
University of California, San DiegoLead Sponsor
1,007 Previous Clinical Trials
1,793,035 Total Patients Enrolled
2 Trials studying Anhedonia
350 Patients Enrolled for Anhedonia
Wellcome Leap Inc.UNKNOWN
Cornell UniversityOTHER
146 Previous Clinical Trials
100,582 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are between the ages of 18 and 80 at the time of screening.
Access to open label neuromodulation treatment after study completion.
You must be on a stable antidepressant therapeutic regimen for at least 6 weeks prior to study enrollment and agree to continue this regimen throughout the study period.

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.