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Behavioural Intervention

Positive Correlation Target for Persistent Depressive Disorder

Phase 1

Waitlist Available

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

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

Must have

Age between 18-65 years old

Diagnosis of major depressive or persistent depressive disorder as per SCID clinical interview

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 weeks

Awards & highlights

Study Summary

This trial aims to study how the brain responds to transcranial magnetic stimulation (TMS) in people with depression by focusing on a specific brain region called the subgenual anterior cingulate cortex

Who is the study for?

This trial is for individuals with various forms of depression, including persistent depressive disorder and major depressive disorder. Participants must be eligible to undergo MRI scans and receive daily TMS treatments on weekdays for 4-6 weeks.Check my eligibility

What is being tested?

The study is testing how a brain region called the subgenual anterior cingulate cortex (sgACC) responds to Transcranial Magnetic Stimulation (TMS). It involves daily TMS sessions combined with MRI scans to observe changes in sgACC engagement during treatment.See study design

What are the potential side effects?

TMS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in rare cases. The MRI procedure might lead to discomfort due to its enclosed nature and loud noises during scanning.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 65 years old.

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I have been diagnosed with major or persistent depression.

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I can understand and agree to the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

sgACC Blood Oxygen Level Dependent (BOLD) signal change following single-pulse fMRI-guided TMS (TMS On vs TMS Off)

Secondary outcome measures

Change in sgACC evoked response Pre/Post TMS treatment with positive and negative sgACC correlated targets

Trial Design

2Treatment groups

Active Control

Group I: Positive Correlation TargetActive Control1 Intervention

TMS treatment will be administered using a TMS target positively correlated with the sgACC.

Group II: Anticorrelation TargetActive Control1 Intervention

TMS treatment will be administered using a TMS target anticorrelated with the sgACC.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,880,038 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,529 Total Patients Enrolled

Frequently Asked Questions

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

Are individuals currently able to apply and participate in this ongoing research study?

"As per clinicaltrials.gov, the ongoing trial is not in active pursuit of new participants. Initially posted on March 30th, 2024 and updated lastly on February 9th, 2024. Despite this trial closing recruitment, there are currently 1398 other studies accepting enrollees at present."

Answered by AI

What are the risks associated with Positive Correlation Target in terms of patient safety?

"Given that this is a Phase 1 trial, the safety rating for Positive Correlation Target is set at 1 by our team. This signifies a scarcity of data validating both its efficacy and safety."

Answered by AI

Is there an age limit that excludes individuals over 60 years old from participating in this trial?

"Eligible candidates for this research must fall within the age range of 18 to 65 years. Interestingly, there are a substantial number of clinical trials available for individuals under 18 and over 65 years old: specifically, 222 studies cater to pediatric patients while 1019 focus on older adults."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Engaging sgACC With TMS for Depression

Desmond Oathes 2024. "Engaging sgACC With TMS for Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06266390.