RECRUITING

Biomarkers of Depression and Treatment Response

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Conditions

Depressive Disorder, Majortranscranial magnetic stimulationdepressionbiomarkerTMSneuroimagingrTMS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is a stratified, parallel-group, single-center study utilizing multimodal imaging techniques to identify biomarkers for Major Depressive Disorder (MDD). The study goal is to identify biomarkers for MDD and treatment response that can be implemented in clinical diagnosis and care as valid and reliable measures, through monitoring neurophysiological and electrophysiological changes across the course of transcranial magnetic stimulation (TMS) treatment.

Official Title

Biomarkers of Depression and Treatment Response

Quick Facts

Study Start:2020-12-01
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04581902

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-70
  2. * Meet Diagnostic and Statistical Manual-V (DSM-V) diagnostic criteria for Major Depressive Disorder in a current major depressive episode, without psychotic features.
  3. * Has Montgomery-Asberg Depressive Rating Scale (MADRS) of \> 19 at baseline, corresponding with moderate to severe depression.
  4. * Demonstrate a moderate level of resistance to antidepressant treatment in the current episode, defined as a failure of 1-4 adequate medication trials.
  5. * If participant is on a regimen of psychotropic medication, no changes in this regimen should be made during the period between the time at which pre-treatment and post-treatment scans are taken.
  6. * Willing and able to undergo non-invasive brain stimulation
  7. * Willing and able to attend research visits for approximately 8 weeks
  8. * Willing and able to provide informed consent
  9. * Ability to speak and read English
  1. * Diagnosed with acute or chronic psychotic symptoms of disorders (e.g. schizophrenia, schizophreniform, schizoaffective disorder) in the current depressive episode.
  2. * Has neurological conditions including epilepsy, cerebrovascular disease, dementia, increased intracranial pressure, having a history of repetitive or severe head trauma, or with primary or secondary tumors in the central nervous system.
  3. * Presence of an implanted magnetic-sensitive medical device in or near the head, including but not limited to pacemaker, vagus nerve stimulator, or metal aneurysm clips or coils, staples, or stents.
  4. * Generalized anxiety disorder as the primary DSM-V disorder during the current MDD episode.
  5. * Meets criteria for alcohol or substance abuse or dependence (other than caffeine) in previous 6 months, as determined by the SCID
  6. * History of seizures
  7. * Implantable hardware not compatible with MRI or with the study
  8. * Inability to comply with study daily visits
  9. * Women who are pregnant, plan to become pregnant, or breast feeding
  10. * Inability to speak and/or read English
  11. * Inability to give consent
  12. * Any active suicidal intent or plan during the current depressive episode, as determined by a score of 3 on Question #9 of Beck's Depression Inventory (scores reviewed daily by study team members versed in scoring clinical scales), or as by a subjective determination by a study clinician during any study visit.

Contacts and Locations

Study Contact

Katherine Scangos, MD, PhD
CONTACT
415-476-7439
brainstim@ucsf.edu
Rebecca Martinez, MS
CONTACT
rebecca.martinez@ucsf.edu

Principal Investigator

Andrew Krystal, MD, MS
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94143
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Andrew Krystal, MD, MS, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-01
Study Completion Date2025-12

Study Record Updates

Study Start Date2020-12-01
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • transcranial magnetic stimulation
  • depression
  • biomarker
  • TMS
  • neuroimaging
  • rTMS

Additional Relevant MeSH Terms

  • Depressive Disorder, Major