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Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 weeks
  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Task 3.1: The investigators will recruit 50 individuals with MDD as an independent cohort and will adopt the EMBARC protocol design, including fMRI and EEG assessments at baseline followed by sertraline prescribed to these patients with clinical assessment of outcomes over 8 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether brain activity and connections can help predict who will improve with sertraline (Zoloft), a medicine for depression. It is for people whose depression started before age 30 and is long-lasting or has happened more than once. Researchers use MRI brain scans and EEG, a test that records brain electrical activity.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • English is your main language, and you can understand the study instructions.
  • A study interview confirms that you currently have major depression.
  • Your depression started before age 30. Your current period of depression has lasted more than 2 years, or you have had at least 2 periods of major depression.
  • Your score on the QIDS depression survey is above 14 at the starting visit and during the week before your first sertraline dose.
  • You are willing and able to have MRI brain scans and EEG tests.

Who can't join

  • An antidepressant did not help during your current period of depression, despite taking a high enough dose for long enough under the study rules.
  • You are pregnant, planning to become pregnant, or breastfeeding.
  • You have a history of bipolar disorder or psychosis (trouble knowing what is real), or had a moderate or severe alcohol or drug use disorder in the past 6 months.
  • You have an unstable mental or physical health condition that may require hospital care or make the study medicine unsafe.
  • You cannot safely have an MRI, or have certain brain conditions, injuries, or surgeries. Examples include stroke, brain tumors, epilepsy (a seizure disorder), serious head injury, or needing medicine to prevent seizures. Some metal objects or devices in the body also rule out MRI.
  • During your current depression, you have had electroconvulsive therapy, vagus nerve stimulation, or transcranial magnetic stimulation—treatments using electricity or magnets to stimulate the brain or nerves. You also cannot be getting regular, research-supported talk therapy for depression.
  • You take medicines that could affect the study results, such as antipsychotic medicines or mood stabilizers.
  • The study team believes you are at serious risk of suicide.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

TX