NCT05892744 Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression
| NCT ID | NCT05892744 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Texas at Austin |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-09-30 |
| Primary Completion | 2027-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2023-09-30 with a primary completion date of 2027-07-15.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: * English as primary language, and comprehension suitable to understand experimenter instructions * 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) * 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. * Have a Quick Inventory of Depression Symptomology Self-Report Measures (QIDS) score \> 14 at baseline and the week prior to first Sertraline administration * Willing and able to undergo MRI and EEG procedures. Exclusion Criteria: * 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 * 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 * Currently pregnant, planning to become pregnant, or breastfeeding * Evidence of current or prior history of psychosis or bipolar disorder as evidenced by self-report or clinical interview * Meeting DSM-5 criteria for a substance-use disorder of moderate or greater severity in the past 6 months * Unstable psychiatric or medical conditions that may require hospitalizations or contraindicate study medication (i.e. autism spectrum disorder, schizophrenia, cancer, congestive heart failure, etc.) * 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. * History of epilepsy, moderate or severe traumatic brain injury, penetrating head injury, brain surgery, brain tumors, or any condition requiring an anticonvulsant * Treatment with electroconvulsive therapy, vagus nerve stimulation, or transcranial magnetic stimulation during the current depressive episode * Concomitant medication use that are likely to interfere or obscure effects from the study medication, including but not limited to antipsychotics and mood stabilizers * Current regular depression-specific evidence-based psychotherapy treatment * Considered by the investigative team to be a significant suicide risk as evidence by self-report or clinical interview
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05892744 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.
What phase is the NCT05892744 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05892744 currently recruiting?
Yes, NCT05892744 is actively recruiting participants. Contact the research team at fonzolab@austin.utexas.edu for enrollment information.
Where is the NCT05892744 trial being conducted?
This trial is being conducted at Austin, United States.
Who is sponsoring the NCT05892744 clinical trial?
NCT05892744 is sponsored by University of Texas at Austin. The trial plans to enroll 50 participants.