Health TrialsbyHealthPanel

Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression

ConditionsMajor Depressive DisorderChronic Major Depression, Recurrent
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Sertraline

    Drug

    50-200mg/day

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Sertraline hydrochloride, up to 200mg/day or maximum tolerable doseOther 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline on the GRID Hamilton Depression Rating Scale (GRID-HAM-D) at 8 weeks

Standardized clinician-administered measure of depression symptom severity. Scores range from 0-52. Lower scores indicate less depressive symptomatology, and so are the more desirable.

Time frame
8 weeks

Secondary outcomes

1

Change from Baseline on the Quick Inventory of Depressive Symptomology-Self Report (QIDS-SR) at 8 weeks

Self-report measure of depressive symptom severity. Scores range from 0 to 27.

Time frame
8 weeks
2

Change from Baseline on the Columbia-Suicide Severity Rating Scale (C-SSRS) at 8 weeks

Clinician-administered measure of suicidal ideation. Scores range from 0 to 25.

Time frame
8 weeks
3

Change from Baseline on the Beck Anxiety Inventory (BAI) at 8 weeks

Self-report measure of anxiety symptom severity. Scores range from 0 to 63.

Time frame
8 weeks
4

Change from Baseline on the Spielberger State Trait Anxiety Inventory-Trait Form (STAI-T) at 8 weeks

Self-report measure of trait anxiety. Scores range from 20 to 80.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas at Austin

Lead sponsor

Lehigh University

Collaborator

Source ClinicalTrials.gov
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