Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression (NCT05892744) | Clinical Trial Compass
RecruitingPhase 4
Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression
United States50 participantsStarted 2023-09-30
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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 o…
What they're measuring
1
Change from Baseline on the GRID Hamilton Depression Rating Scale (GRID-HAM-D) at 8 weeks