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Transcranial Magnetic Stimulation Device

Accelerated Theta Burst Stimulation for Bipolar Depression

N/A

Waitlist Available

Led By Nolan Williams, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to provide informed consent

Male or female, 18 to 80 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and recurrent post-treatment time-points (weekly for 8 weeks and every two weeks up to 6 months)

Awards & highlights

Study Summary

This trial will test if a transcranial magnetic stimulation device can help treat bipolar depression when used on an accelerated schedule.

Who is the study for?

This trial is for adults aged 18-80 with treatment-resistant bipolar depression, who are on a stable dose of mood stabilizers. Participants must score above certain thresholds on depression scales and be in good health. Women must not be able to bear children or use birth control. Exclusions include epilepsy, psychosis, schizophrenia, heart disease, significant suicide risk, autism spectrum disorder, opiate use, and metal in the head.Check my eligibility

What is being tested?

The study tests an accelerated form of brain stimulation called theta-burst stimulation for those with bipolar depression that hasn't improved with standard treatments. All participants will receive this non-invasive therapy using magnetic pulses over several sessions.See study design

What are the potential side effects?

Theta-burst stimulation may cause discomfort at the site of application on the scalp, headache or lightheadedness during or after treatment sessions. Some individuals might experience temporary hearing changes due to the noise during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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People who want to participate in the study must be taking a mood stabilizer and their medication dose must remain stable during the study.

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You have had a bad reaction to antidepressant medication in the past, but you do not need to be currently taking antidepressants.

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Participants had to screen positive on the BDI-II, with a score of >=17 at both the screening and baseline visits in order to be eligible for the study.

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The subject must have a total MADRS score of >/=20 at both the screening and baseline visits in order to be eligible for the study.

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He is in good general health and has no known medical conditions.

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If female, a status of not being able to have children or using an acceptable form of birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and recurrent post-treatment time-points (weekly for 8 weeks and every two weeks up to 6 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and recurrent post-treatment time-points (weekly for 8 weeks and every two weeks up to 6 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and recurrent post-treatment time-points (weekly for 8 weeks and every two weeks up to 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

Change from baseline Montgomery Asberg Depression Rating Scale (MADRS)

Secondary outcome measures

Change from baseline Young Mania Rating Scale (YMRS)

Other outcome measures

Change from baseline Internal State Scale (ISS)

Change from baseline Inventory of Depressive Symptoms (IDS-SR)

Change from baseline in the Brief Visuospatial Memory Test - Revised (BVMT-R)

+5 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Accelerated intermittent theta burst treatmentExperimental Treatment1 Intervention

All participants will receive accelerated intermittent theta-burst stimulation.

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,381 Previous Clinical Trials

17,333,638 Total Patients Enrolled

Nolan Williams, MDPrincipal InvestigatorStanford University

16 Previous Clinical Trials

1,202 Total Patients Enrolled

Ian Kratter, MD, PhDPrincipal InvestigatorStanford University

2 Previous Clinical Trials

240 Total Patients Enrolled

Media Library

Major Depressive Disorder Research Study Groups: Accelerated intermittent theta burst treatment

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruiting process for participants still ongoing?

"According to the clinicaltrials.gov records, this trial is not currently recruiting participants; it was initially posted on July 1st 2019 and last updated in November 2021. Though no longer enrolling patients for this study, there are over a thousand other active trials seeking new volunteers."

Answered by AI

What is the ultimate goal of this research endeavor?

"The primary endpoint that will be monitored during this trial at baseline and post-treatment is the Change from Baseline Montgomery Asberg Depression Rating Scale (MADRS). The secondary endpoints are the Change from Baseline Columbia Suicide Severity Rating Scale (C-SSRS), which was created by researchers at Columbia University to rate suicidal ideation on a scale, Hamilton Rating Scale for Depression (HAM-21) - a 21 item clinical assessment measuring depressive symptoms scored 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression≥ 23 = Very Severe Depressions as well"

Answered by AI

Is this research restricted to individuals under 40, or are those over that age permitted as well?

"Patients that wish to participate in the trial must be of legal age (18 and over) but not exceed 80 years old."

Answered by AI

Is there an opportunity to participate in this clinical experiment?

"This clinical trial is recruiting 30 people with unipolar depression between the ages of 18 and 80. Notably, the following criteria must be met: an adequate dose of a mood stabiliser should already have been prescribed to applicants; they need to meet BDI-II and MADRS score thresholds at both screening and baseline visits (Day -5/-14 and Day 0); those who had intolerance to antidepressant medications in the past do not need to be currently taking antidepressants; non-childbearing potential females or use of birth control are also mandatory requirements; good general health as indicated by medical history; males/females aged from 18 through 80 years"

Answered by AI