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Procedure

Transcranial Magnetic Stimulation for Depression (FREED Trial)

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-treatment (within 24 hours prior to first treatment) and post-treatment (within 72 hours of final treatment)

Awards & highlights

FREED Trial Summary

This trial will compare 3 types of TBS (Theta Burst Stimulation) in 75 people with TRD (treatment-resistant depression). EEG data will be collected to measure changes in fronto-parietal theta connectivity and depressive symptoms. Hypothesis: Ind-iTBS will be more effective than targeted-iTBS and standard iTBS.

Who is the study for?

This trial is for adults aged 18-80 with major depressive disorder who haven't improved after trying at least one antidepressant. They must be able to consent, have a moderate to severe depression score, and not have started new antidepressants recently.Check my eligibility

What is being tested?

The FREED study tests three types of Transcranial Magnetic Stimulation (TMS) treatments over four weeks: fully individualized iTBS targeting frequency and E-field, iTBS targeting only E-field, and standard iTBS. It measures changes in brain connectivity and depression severity.See study design

What are the potential side effects?

Common side effects of TMS may include discomfort at the treatment site, headache, lightheadedness, or seizures in rare cases. Individual experiences with side effects can vary.

FREED Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-treatment (within 24 hours prior to first treatment) and post-treatment (within 72 hours of final treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-treatment (within 24 hours prior to first treatment) and post-treatment (within 72 hours of final treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-treatment (within 24 hours prior to first treatment) and post-treatment (within 72 hours of final treatment) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change from pre-treatment in fronto-parietal theta connectivity at post-treatment

FREED Trial Design

3Treatment groups

Active Control

Group I: iTBS individualized using E-field targeting only (targeted-iTBS)Active Control1 Intervention

In the targeted-iTBS, the coil placement and current amplitude will be provided using individualized E-field modeling and coordinate-based cortical targeting.

Group II: The fully individualized form of iTBS (BOTH the frequency and E-field targeting approaches)Active Control1 Intervention

In the Ind-iTBS, the coil placement and current amplitude will be provided using individualized E-field modeling and coordinate-based cortical targeting. The stimulation frequency will also be individualized according to EEG-derived TGC.

Group III: Standard iTBS treatment (i.e., typical iTBS localized to the DLPFC using the Beam F3 method)Active Control1 Intervention

The standard iTBS will be delivered with the typical 5Hz/50Hz patterned frequencies used in the FDA-approved treatment protocol and stimulation will be delivered according to the Beam F3 targeting.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,122 Previous Clinical Trials

1,520,969 Total Patients Enrolled

30 Trials studying Depression

56,178 Patients Enrolled for Depression

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,775 Total Patients Enrolled

55 Trials studying Depression

47,208 Patients Enrolled for Depression

Frequently Asked Questions

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

Are there any restrictions preventing my participation in this trial?

"This trial is recruiting seventy-five individuals with depression that are aged between eighteen and eighty. In order to participate, potential subjects must possess the capacity to provide informed consent, meet DSM-5 criteria for major depressive episode (MDE), have an MADRS score higher than 19 indicating moderate - severe depression, not increase/initiate new antidepressant medication in the month prior to screening as well as present a failed 3rd level of antidepressant treatment according to ATHF-SF classification."

Answered by AI

Does this scientific experiment include individuals over the age of eighty?

"This clinical trial requires that patients are at least 18 years old, with the upper age limit capped at 80."

Answered by AI

What is the aggregate patient count of this clinical experiment?

"Affirmative. Clinicaltrials.gov has information that this trial is currently enlisting volunteers, and it was initially made available on August 31st 2023 with a recent update posted November 5th 2023. The study requires 75 patients to be enrolled from 2 locations."

Answered by AI

Is this clinical experiment accepting new participants?

"Affirmative. The information on clinicaltrials.gov denotes that this experiment is actively seeking participants, having been posted initially on August 31st 2023 and last updated November 5th 2023. This trial requires 75 patients to be enrolled from two sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Frequency and E-field Enhancement of ITBS for Depression (FREED)

Zafiris Daskalakis 2023. "Frequency and E-field Enhancement of ITBS for Depression (FREED)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06003309.

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