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Behavioural Intervention
Accelerated Brain Stimulation for Depression (MediTMS Trial)
N/A
Recruiting
Led By Jyoti Mishra, PhD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Moderate to severe depression (PHQ-9 scale score >9 with confirmation using the Structured Clinical Interview for DSM-5 Disorders)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 weeks
Awards & highlights
MediTMS Trial Summary
This trial is testing a next-generation rTMS protocol that is guided by principles of brain plasticity, in order to improve the efficacy of rTMS for the treatment of depression.
Who is the study for?
This trial is for adults with moderate to severe depression who haven't had success with 1-3 antidepressants or can't tolerate them. Participants should not have active substance abuse, psychotic disorders, metal implants in the brain, history of stroke or seizures, and shouldn't be at immediate risk of suicide.Check my eligibility
What is being tested?
The study tests a new rTMS protocol that aims to improve brain plasticity and treat depression more effectively. It involves magnetic stimulation pulses on a specific part of the brain while patients are in a state of internal attention related to their condition.See study design
What are the potential side effects?
rTMS may cause discomfort at the stimulation site, headache, lightheadedness, or tingling. Rarely it could lead to seizures or hearing loss if ear protection isn’t used during treatment.
MediTMS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with moderate to severe depression.
MediTMS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 weeks
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 Clinical Depression (Remission)
Change from baseline brain activity in attention-to-breath task
MediTMS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Medi1TMSExperimental Treatment1 Intervention
rTMS theta-burst protocol paired with a consistent attention-to-breath task
Group II: Medi2TMSActive Control1 Intervention
rTMS theta-burst protocol paired with an intermittent deep breathing task
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Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,130 Previous Clinical Trials
1,552,806 Total Patients Enrolled
30 Trials studying Depression
55,609 Patients Enrolled for Depression
Jyoti Mishra, PhDPrincipal Investigator - University of California, San Diego
University of California, San Diego
4 Previous Clinical Trials
166 Total Patients Enrolled
2 Trials studying Depression
110 Patients Enrolled for Depression
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a diagnosed psychotic disorder.My depression hasn't improved after 1-3 antidepressants, or I couldn't tolerate 2 of them.I have been diagnosed with moderate to severe depression.I have a condition or device that could increase the risk of magnetic stimulation complications.
Research Study Groups:
This trial has the following groups:- Group 1: Medi2TMS
- Group 2: Medi1TMS
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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