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Recruiting NCT05194098

NCT05194098 Using Electrophysiology to Index Non-invasive Brain Stimulation Effects on Reward System Functioning in Depression

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Clinical Trial Summary
NCT ID NCT05194098
Status Recruiting
Phase
Sponsor San Francisco Veterans Affairs Medical Center
Condition Major Depressive Disorder
Study Type INTERVENTIONAL
Enrollment 45 participants
Start Date 2021-10-01
Primary Completion 2024-09-30

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 65 Years
Study Type INTERVENTIONAL
Interventions
TMS: single session intermittent theta burst stimulation (iTBS) to dorsomedial prefrontal target in individuals with major depressive disorder, via MagVenture MagPro R30 device / Cool-DB80 A/P coilSHAM (inactive) TMS stimulation

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 45 participants in total. It began in 2021-10-01 with a primary completion date of 2024-09-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Depression is a leading cause of morbidity and mortality, conferring substantial healthcare and societal costs. By studying methods to non-invasively target neural circuitry involved in reward responsivity, information generated by this project will improve understanding of the circuit alterations that underlie motivation and pleasure deficits in depression, and could also lead to the development of biologically-based markers of neurostimulation-based treatment response.

Eligibility Criteria

• Our studies require some in-person visits to our research lab, located at 42nd Ave and Clement St in San Francisco. Inclusion Criteria: * All participants * 18-65 years old * Normal (or corrected to normal) vision * Participants with MDD * Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for MDD * Screened for TMS and MRI safety * On a stable psychiatric medication regime for \> 1 month Exclusion Criteria (all participants): * Premorbid IQ estimate \< 70 * Past or present neurological problems (including seizures and head trauma resulting in neurological or cognitive sequelae) * Loss of consciousness \> 30 minutes or any loss of consciousness with neurological sequelae * Major medical conditions (e.g., seizure disorders, treatment with anticonvulsant medication, endocrine disorders, significant cardiac pathology), or other physical conditions if they preclude participation in EEG, TMS, or MRI protocols (e.g. peripheral nerve damage, limb paralysis etc.) * Substance dependence, within the past year, current (past 3 months) substance misuse, or failed urine toxicology on the day of neuroimaging sessions * Known claustrophobia * Pregnancy (a pregnancy urine test will be conducted to rule-out pregnancy) Exclusion criteria (Participants with MDD only) * Past or present DSM-5 (SCID-5) 'Schizophrenia Spectrum or Other Psychotic Disorder' diagnosis * Past or present DSM-5 (SCID-5) Bipolar and Related Disorders Diagnosis * Past or present DSM-5 (SCID-5) MDD with psychotic features (mood congruent or mood incongruent) * Past or present DSM-5 (SCID-5) Gambling Disorder Exclusion Criteria (HCs only) • DSM-5 (SCID-5) criteria for any psychiatric disorder

Contact & Investigator

Central Contact

Jason B Hemmerle, MBA

✉ jason.hemmerle@ucsf.edu

📞 4152214810

Principal Investigator

Susanna L Fryer, PhD

PRINCIPAL INVESTIGATOR

University of California, San Francisco

Frequently Asked Questions

Who can join the NCT05194098 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05194098 currently recruiting?

Yes, NCT05194098 is actively recruiting participants. Contact the research team at jason.hemmerle@ucsf.edu for enrollment information.

Where is the NCT05194098 trial being conducted?

This trial is being conducted at San Francisco, United States.

Who is sponsoring the NCT05194098 clinical trial?

NCT05194098 is sponsored by San Francisco Veterans Affairs Medical Center. The principal investigator is Susanna L Fryer, PhD at University of California, San Francisco. The trial plans to enroll 45 participants.

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