RECRUITING

Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression

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Conditions

Major Depressive DisorderChronic Major Depression, RecurrentDepressionChronic DepressionMajor DepressionRecurrent DepressionantidepressantsertralinefMRIEEGbiomarker

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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

The purpose of the study is to identify brain biomarkers and characteristics that predict individual responses to treatment of major depression with the antidepressant drug sertraline (tradename Zoloft), a common selective serotonin reuptake inhibitor (SSRI) antidepressant. Our central hypothesis is that brain activity and connections jointly measured with functional magnetic resonance imaging (fMRI) and electroencephalogram (EEG) will be able to predict an individual's response to sertraline treatment.

Official Title

Establishing Multimodal Brain Biomarkers Using Data-driven Analytics for Treatment Selection in Depression

Quick Facts

Study Start:2023-09-30
Study Completion:2026-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05892744

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 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * English as primary language, and comprehension suitable to understand experimenter instructions
  2. * Meet criteria for a current major depressive episode diagnosed through the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) (SCID-5)
  3. * Meet criteria for early onset (prior to age 30) of depression and either: a) current major depressive episode lasts for \> 2 years; or b) participant meets criteria for recurrent major depression as evidenced by 2 or more major depressive episodes (including current episode) in their lifetime. These criteria will be assessed by the SCID-5.
  4. * Have a Quick Inventory of Depression Symptomology Self-Report Measures (QIDS) score \> 14 at baseline and the week prior to first Sertraline administration
  5. * Willing and able to undergo MRI and EEG procedures.
  1. * Non-early onset (i.e., after age 30), non-chronic (current episode lasting less than 2 years or only one lifetime major depressive episode, including current episode) qualifying Major Depressive Disorder
  2. * Must not have failed to respond to any prior antidepressant treatment in the current episode of sufficient duration and dose as defined by the Massachusetts General Hospital (MGH) Antidepressant Treatment Response Questionnaire
  3. * Currently pregnant, planning to become pregnant, or breastfeeding
  4. * Evidence of current or prior history of psychosis or bipolar disorder as evidenced by self-report or clinical interview
  5. * Meeting DSM-5 criteria for a substance-use disorder of moderate or greater severity in the past 6 months
  6. * Unstable psychiatric or medical conditions that may require hospitalizations or contraindicate study medication (i.e. autism spectrum disorder, schizophrenia, cancer, congestive heart failure, etc.)
  7. * Contraindications to MRI including, but not limited to, history of stroke, brain tumors, brain hemorrhages, internal wires, electrodes, pacemakers, implants, irremovable ferromagnetic objects in head that are unsafe for MRI and/or cause large distortions in imaging data, etc.
  8. * History of epilepsy, moderate or severe traumatic brain injury, penetrating head injury, brain surgery, brain tumors, or any condition requiring an anticonvulsant
  9. * Treatment with electroconvulsive therapy, vagus nerve stimulation, or transcranial magnetic stimulation during the current depressive episode
  10. * Concomitant medication use that are likely to interfere or obscure effects from the study medication, including but not limited to antipsychotics and mood stabilizers
  11. * Current regular depression-specific evidence-based psychotherapy treatment
  12. * Considered by the investigative team to be a significant suicide risk as evidence by self-report or clinical interview

Contacts and Locations

Study Contact

Greg Fonzo, Ph.D.
CONTACT
512-495-5856
fonzolab@austin.utexas.edu
Lauren Enten, B.S.A
CONTACT
lauren.enten@austin.utexas.edu

Study Locations (Sites)

Health Discovery Building (HDB), 1601 Trinity St., Bldg B., Z0600
Austin, Texas, 78712
United States

Collaborators and Investigators

Sponsor: University of Texas at Austin

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 Date2023-09-30
Study Completion Date2026-08-01

Study Record Updates

Study Start Date2023-09-30
Study Completion Date2026-08-01

Terms related to this study

Keywords Provided by Researchers

  • Depression
  • Chronic Depression
  • Major Depression
  • Recurrent Depression
  • antidepressant
  • sertraline
  • fMRI
  • EEG
  • biomarker

Additional Relevant MeSH Terms

  • Major Depressive Disorder
  • Chronic Major Depression, Recurrent