Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Texas at Austin
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Sertraline
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Texas at Austin
Lead sponsor
Lehigh University
Collaborator
Source ClinicalTrials.gov