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TMS for Depression and Anxiety
Phase 2
Waitlist Available
Led By Shan H Siddiqi, MD
Research Sponsored by Brigham and Women's Hospital
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 (before treatment), 3 weeks (after 15 treatments), and 6 weeks (after 30 treatments)
Awards & highlights
Study Summary
This trial will compare two different ways of using transcranial magnetic stimulation to treat people with major depressive disorder. The goal is to see if one method is better than the other at treating both depression and anxiety.
Who is the study for?
This trial is for adults aged 18-65 with major depressive disorder who have not improved after at least one antidepressant treatment. Participants must have a Beck Depression Inventory score of 20+ and an Anxiety Inventory score of 16+. It's not for those with dementia, bipolar, seizure disorders, certain metal implants, severe substance use in the past six months (except cannabis/nicotine), active psychosis or suicidal thoughts.Check my eligibility
What is being tested?
The study tests two different targets for transcranial magnetic stimulation (TMS) to see which is more effective for treating symptoms of depression versus anxiety. TMS is a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain.See study design
What are the potential side effects?
TMS may cause discomfort at the site of stimulation, headache, lightheadedness, or tingling. Rarely it can induce seizures or mania in people with bipolar disorder. Most side effects are mild and improve shortly after treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (before treatment), 3 weeks (after 15 treatments), and 6 weeks (after 30 treatments)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (before treatment), 3 weeks (after 15 treatments), and 6 weeks (after 30 treatments)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anxiety
Mental Depression
Secondary outcome measures
Multidimensional battery of emotional questionnaires
Multidimensional task-based emotional assessment
NIH Toolbox cognitive battery
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Dysphoric targetExperimental Treatment1 Intervention
The "dysphoric" target is a region in the dorsolateral prefrontal cortex. TMS targeted to this region has been shown to be more effective for depression than anxiety.
Group II: Anxiosomatic targetExperimental Treatment1 Intervention
The "anxiosomatic" target is a region in the dorsomedial prefrontal cortex. TMS targeted to this region has been shown to be more effective for anxiety than depression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial magnetic stimulation
2015
Completed Phase 4
~520
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,622 Previous Clinical Trials
11,468,717 Total Patients Enrolled
28 Trials studying Depression
115,913 Patients Enrolled for Depression
Shan H Siddiqi, MDPrincipal InvestigatorBrigham and Women's Hospital
2 Previous Clinical Trials
195 Total Patients Enrolled
1 Trials studying Depression
180 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a condition called seizure disorder, which makes you unable to receive a specific type of treatment called rTMS.You have been diagnosed with bipolar disorder.You have had a serious problem with drugs or alcohol in the past six months, except for cannabis and nicotine.You have been diagnosed with major depressive disorder by a medical professional and at least one medication used to treat it has not worked for you.You are currently experiencing severe mental health symptoms that affect your thinking and perception.You have moderate or severe autism.You are currently having thoughts of hurting yourself or thinking about suicide.You have severe pain or illness that gets worse when lying down in the MRI scanner.You have been diagnosed with a type of mental illness called schizophrenia or a related disorder.You have a strong fear of being in small, enclosed spaces (like an MRI machine).You have a condition called dementia, which is diagnosed by a specialist doctor who treats problems with the brain.You currently have a mood disorder caused by drugs or substances you have used.Your score on the Beck Anxiety Inventory (BAI) is 16 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Dysphoric target
- Group 2: Anxiosomatic target
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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