Your session is about to expire
← Back to Search
Behavioural Intervention
Neuromodulation for Depression
N/A
Recruiting
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
Currently diagnosed with Major Depressive Disorder (MDD) or Bipolar Disorder type II and meets criteria for a Major Depressive Episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5)
Must be on a stable antidepressant therapeutic regimen for 6 weeks prior to study enrollment and agree to continue this regimen throughout the study period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study Summary
This trial is testing noninvasive brain stimulation for the treatment of anhedonic depression, which is part of a larger study conducted at three different universities. The goal is to compare different interventions and create an end-to-end model of anhedonic depression.
Who is the study for?
This trial is for adults aged 18-80 with Major Depressive Disorder or Bipolar II, experiencing a major depressive episode and resistant to standard antidepressant treatments. Participants must be proficient in English, willing to follow the study procedures, have ongoing psychiatric care, and agree not to change their stable antidepressant regimen during the study. Pregnant individuals or those with certain mental health conditions, substance abuse issues, or contraindications for rTMS or MRI are excluded.Check my eligibility
What is being tested?
The trial tests three forms of accelerated intermittent theta burst stimulation (aiTBS) on anhedonic depression: individualized aiTBS tailored by brain response frequency and bioconductivity modeling; standard aiTBS; and sham treatment as placebo. Delivered over one week at UCSD among other sites, it aims to develop biomarkers for tailoring treatment options.See study design
What are the potential side effects?
Potential side effects from aiTBS may include discomfort at the stimulation site, headache, lightheadedness, tingling or spasms of facial muscles. Serious risks are rare but can include seizures or mania in people with bipolar disorder.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with MDD or Bipolar II and am currently experiencing a major depressive episode.
Select...
I have been on a stable antidepressant regimen for 6 weeks and will continue it during the study.
Select...
I have been diagnosed with Major Depressive Disorder or Bipolar II.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in DARS Scores
Change in MADRS Scores
Secondary outcome measures
Assessment of Neuroplasticity
Other outcome measures
Cross-Sectional TMS-EEG Biomarker
Cross-Sectional fMRI Biomarker
Predictive TMS-EEG Biomarker
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Individualized Accelerated Intermittent Theta Burst Stimulation (Ind-aiTBS)Experimental Treatment1 Intervention
Patients will receive individualized unilateral accelerated theta-burst stimulation to the left dorsal lateral prefrontal cortex for 5 consecutive days, with a total of 10 hours a day. Treatment will be 10min with 50min of breaks in between the 10 sessions. The target for stimulation will be individualized using the participant's fMRI scans by finding the region of the DLPFC most anti-correlated with the subgenual anterior cingulate cortex (sgACC). This target will be determined using e-field modeling and theta-gamma coupling.
Group II: Standard Accelerated Intermittent Theta Burst Stimulation (Std-aiTBS)Active Control1 Intervention
Patients will receive unilateral accelerated theta-burst stimulation to the left dorsal lateral prefrontal cortex for 5 consecutive days, with a total of 10 hours a day. Treatment will be 10min with 50min of breaks in between the 10 sessions.
Group III: Sham Accelerated Intermittent Theta Burst Stimulation (sham)Placebo Group1 Intervention
Patients will receive sham unilateral accelerated theta-burst stimulation to the left dorsal lateral prefrontal cortex for 5 consecutive days, with a total of 10 hours a day. Treatment will be 10min with 50min of breaks in between the 10 sessions.
Find a Location
Who is running the clinical trial?
Wellcome Leap Inc.UNKNOWN
Cornell UniversityOTHER
166 Previous Clinical Trials
14,089,731 Total Patients Enrolled
Wellcome Leap OrganizationUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I take more than 2 mg/day of lorazepam or a similar medication.I am between 18 and 80 years old.I have been on a stable antidepressant regimen for 6 weeks and will continue it during the study.I can get neuromodulation treatment after the study ends.I have a history of serious brain or nerve conditions.My depression symptoms have not worsened by 30% or more recently.I have been diagnosed with MDD or Bipolar II and am currently experiencing a major depressive episode.You have a severe borderline personality disorder.I have a hormone disorder that is not fully treated.I do not have metal implants in my head, a history of seizures, or known brain lesions.You have been diagnosed with intellectual disability or autism spectrum disorder.You have tested positive for illegal drugs in a urine test.I have access to psychiatric care before and after the study.I have tried at least two antidepressants without success or could not tolerate them.Your MADRS score is 20 or higher at the first screening visit.I've had more than 8 ECT sessions without noticeable improvement.You cannot have an MRI because you have metal in your body that can be affected by the machine.I can get neuromodulation treatment after the study ends.I have been diagnosed with Major Depressive Disorder or Bipolar II.You currently have a serious problem with drugs or alcohol, or you are showing signs of needing to stop using them.I have used ketamine or had ECT for depression in the last 30 days.I have a history of or currently have a psychotic disorder or depression with psychotic features.You have serious thoughts about hurting yourself with a plan.Your MADRS score is 20 or higher at the first screening visit.
Research Study Groups:
This trial has the following groups:- Group 1: Sham Accelerated Intermittent Theta Burst Stimulation (sham)
- Group 2: Standard Accelerated Intermittent Theta Burst Stimulation (Std-aiTBS)
- Group 3: Individualized Accelerated Intermittent Theta Burst Stimulation (Ind-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.
Anhedonia Patient Testimony for trial: Trial Name: NCT05537285 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research permit the participation of senior citizens?
"The parameters for being considered a participant in this clinical trial mandate that applicants be aged 18 to 80. Notably, there are 33 studies available for those below the age of majority and 221 trials open to people over 65 years old."
Answered by AI
Am I eligible to be a participant in this research endeavor?
"This trial requires participants to be between 18 and 80 years of age and suffering from anhedonia. A total of 129 individuals need to enroll in order for the study to be a success."
Answered by AI
What is the enrollment capacity for this medical investigation?
"Affirmative. According to the information published on clinicaltrials.gov, this medical research project is currently seeking out volunteers. This trial was first posted on August 1st 2022 and recently modified on September 11th 2022 with an aim of recruiting 129 individuals at one particular site."
Answered by AI
Are there any opportunities for new participants to join the current clinical trial?
"Affirmative, according to clinicaltrials.gov the trial is actively seeking participants after being posted on August 1st 2022 and last edited on September 11th 2022. The study looks for 129 individuals in total from a single site."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
What site did they apply to?
UCSD Interventional Psychiatry
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I’ve tried many SSRI, SNRI, atypicals and mood stabilizers that didn’t work or worked initially then side effects were intolerable.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
if I’ve had TMS once before and it helped can I be in the trial?
PatientReceived 2+ prior treatments
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger