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Behavioural Intervention
aiTBS for Depression
N/A
Recruiting
Led By Ian Kratter, MD, PhD
Research Sponsored by Stanford University
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 baseline and immediate post-treatment, 1-month
Awards & highlights
Study Summary
This trial is testing if a brain stimulation technique can help people with depression that doesn't respond to other treatments.
Who is the study for?
This trial is for adults aged 18-80 with bipolar II disorder currently experiencing a major depressive episode, who haven't responded to standard treatments. They must be in good health, not have hypomania or psychosis, and women must use effective contraception. Excluded are those with metal in their head, pacemakers, substance abuse issues, severe insomnia, certain mental health conditions like anxiety disorders or personality disorders, recent suicidal behavior or thoughts.Check my eligibility
What is being tested?
The study tests accelerated intermittent theta-burst stimulation (aiTBS) targeting the left dorsolateral prefrontal cortex to treat treatment-resistant depression in bipolar II disorder patients. It's a double-blind trial comparing active aiTBS against sham (placebo) aiTBS using the MagPro rTMS system.See study design
What are the potential side effects?
While specific side effects of aiTBS aren't detailed here, similar treatments can cause discomfort at the stimulation site on the scalp, headache or lightheadedness immediately after treatment. There may also be a risk of seizure although it's considered rare.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and immediate post-treatment, 1-month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and immediate post-treatment, 1-month
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)
Change in resting-state functional connectivity
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active aiTBSActive Control1 Intervention
Participants will be randomized to active or sham aiTBS condition, and receive 10 aiTBS to left DLPFC (LDLPFC) sessions a day for 5 days of course.
Group II: Sham aiTBSPlacebo Group1 Intervention
Participants will be randomized to active or sham aiTBS condition, and receive 10 aiTBS to left DLPFC (LDLPFC) sessions a day for 5 days of course.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,560 Total Patients Enrolled
22 Trials studying Bipolar Disorder
1,658 Patients Enrolled for Bipolar Disorder
Ian Kratter, MD, PhDPrincipal InvestigatorStanford University
2 Previous Clinical Trials
210 Total Patients Enrolled
1 Trials studying Bipolar Disorder
30 Patients Enrolled for Bipolar Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My movement disorder won't interfere with treatment.I have been on a mood stabilizer for 6 weeks and will continue it during the study.I have never undergone TMS therapy.I don't have brain conditions that could affect the study.My primary diagnosis is not bipolar II disorder.I have a history of severe, untreatable migraines.I am experiencing withdrawal symptoms from alcohol or benzodiazepines.I've had more than 8 ECT sessions without improvement.I usually sleep at least 5 hours each night.I have a history of epilepsy or seizures.I have had brain surgery for depression.I have a history of heart issues, including heart attack or heart failure.My treatment's intensity is more than 65% of the maximum level.I have used ketamine or had ECT for depression in the last 4 weeks.My mood symptoms have been stable, without a 30% change in severity recently.I am between 18 and 80 years old with bipolar II disorder, currently experiencing a major depressive episode.
Research Study Groups:
This trial has the following groups:- Group 1: Active aiTBS
- Group 2: Sham aiTBS
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.
Does this experiment include participants aged sixty or above?
"The minimum age requirement for this research project is 18 and the maximum allowable age to participate is 80."
Answered by AI
Are the requirements for this medical study compatible with my current health status?
"This research study is currently seeking 60 participants with a bipolar disorder diagnosis and between the ages of 18-80."
Answered by AI
Are there any vacancies to participate in the research project?
"Affirmative. Records on clinicaltrials.gov verify that this investigation, which was posted in December of 2022, is presently enrolling participants. The research team aim to recruit 60 individuals from a single centre."
Answered by AI
What is the present enrollment of this experimental trial?
"Yes, clinicaltrials.gov corroborates that this study is actively recruiting participants. The first public listing was released on December 20th 2022 and has since been updated on May 6th 2023. As of now, 60 patients must be recruited at a single medical site."
Answered by AI
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