RecruitingNot applicable

Rapid Antidepressant Dynamics in Acute Neuromodulation Treatments

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 55 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: 1 week
  • 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
  • "Participants will: Receive three types of brain stimulation (intermittent, continuous, and sham) in different sessions Undergo MRI scans during the administration of either a fast-acting or conventional antidepressant."
  • "Following each stimulation session, participants will complete an MRI protocol that includes administration of either a fast-acting or conventional antidepressant, as well as resting-state functional imaging."
  • "Behavioral outcomes include mood ratings acquired repeatedly during the scanning session and via daily remote assessments for one week post-stimulation."
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 how different types of brain stimulation without surgery affect mood and brain activity in adults ages 18–55 with major depression. It also studies how brain stimulation works with antidepressant medicines.

The goal of this clinical trial is to learn how different types of non-invasive brain stimulation affect mood and brain function in adults with major depressive disorder (MDD). It will also study how brain stimulation may work together with antidepressant treatments. The main questions this study aims to answer are: How do different patterns of brain stimulation affect mood in people with depression? Do brain networks involved in emotion and self-reflection respond differently depending on the type of stimulation? What are the combined effects of brain stimulation and antidepressant treatments on mood and brain activity? Researchers will compare different brain stimulation patterns and target areas to understand their individual and combined effects. Participants will: Receive three types of brain stimulation (intermittent, continuous, and sham) in different sessions Undergo MRI scans during the administration of either a fast-acting or conventional antidepressant. Complete mood assessments during the scan and for one week after each session This study may help identify brain-based strategies to improve treatment for depression. In addition, a subset of participants (\~25) will complete a reward-guided decision-making fMRI task for feasibility purposes.

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

Eligibility

Who can join

  • You are 18–55 years old.
  • You have major depressive disorder. You may also have an anxiety disorder or a personality disorder.
  • You are not taking medicines that affect mood, thinking, or behavior when you join.

Who can't join

  • You are pregnant or breastfeeding.
  • You have depression with loss of touch with reality, schizophrenia, bipolar disorder, or another excluded mental health disorder. Anxiety disorders are allowed.
  • You have had severe substance use in the past 2 months, not counting nicotine, based on a study interview.
  • You need hospital care right away, are actively suicidal, or are at high risk of suicide.
  • You have epilepsy, a condition that causes seizures, or another condition that needs anti-seizure medicine.
  • In the past 2 months, you received vagus nerve stimulation, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS). These treatments use electrical or magnetic stimulation.
  • You have taken psychiatric medicine or medicine added to boost its effects in the past 21 days, or you are receiving talk therapy focused on depression.
  • You are in another study, or screening shows that MRI brain scans or TMS magnetic brain stimulation would not be safe for you.

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

Official eligibility criteria

Inclusion criteria: 1. Adults ages 18-55 (\~60% female). 2. Diagnosis of Major Depressive Disorder (MDD) with or without comorbid anxiety disorders (e.g., panic disorder) or Axis II disorders. 3. Psychotropic-free at enrollment. Exclusion Criteria: 1. being pregnant or breastfeeding; 2. diagnosis of psychotic depression, schizophrenia, bipolar disorder, or other Axis I disorders, except for anxiety disorders; 3. severe substance use (excluding nicotine) in the last 2 months as determined by using the MINI, a structured interview that uses the Diagnostic and Statistical Manual of Mental Disorders; 4. requiring immediate hospitalization; 5. epilepsy or conditions requiring an anticonvulsant; 6. receiving vagus nerve stimulation, electroconvulsive therapy (ECT), or TMS in the last 2 months; 7. currently taking or have taken within the last 21 days psychiatric medication or augmenting agents; 8. receiving depression-specific psychotherapy; 9. actively suicidal or considered a high suicide risk; 10. enrolled in another study; or 11. MRI/TMS contraindication as determined by the fMRI and TMS screening questionnaires

Study sites (1)

PA