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Amygdala Neurofeedback for Depression - Large Scale Clinical Trial

Confirmatory Efficacy Randomized Clinical Trial of Amygdala Neurofeedback for Major Depressive Disorder

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 year

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 complete the BDI-II monthly for one year following completion of the neurofeedback intervention."
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 feedback from live MRI brain scans can treat major depression on its own. The training aims to increase how the amygdala, a part of the brain involved in emotions, responds to positive memories. It is for adults ages 18–55 who currently have depression.

The goal of this study is to evaluate whether rtfMRI-nf training to increase the amygdala response to positive memories may serve as a stand-alone intervention for major depressive disorder

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.
  • Your main diagnosis is major depressive disorder, and you are currently depressed.
  • You can give written consent before joining the study.
  • You take no medicine for depression, or your antidepressant treatment has been stable for at least 4 weeks. Medicines that work will not be stopped for this study.

Who can't join

  • You have a serious or unstable illness affecting your heart, lungs, hormones, brain, nerves, or digestive system, or another unstable medical condition.
  • You have a current severe alcohol or drug use disorder, except for nicotine or caffeine. A clinician will decide whether mild or moderate use would affect the study.
  • You have a history of brain injury, bipolar I or II disorder, a disorder involving loss of touch with reality, or a mental disorder caused by a physical brain problem.
  • You cannot have an MRI because of fear of tight spaces or another MRI safety issue, such as metal fragments in your body.
  • You are pregnant or breastfeeding.
  • You cannot complete questionnaires written in English.
  • Within 3 weeks of testing, you use antipsychotics, seizure medicines, stimulants, benzodiazepines (some anxiety or sleep medicines), beta-blockers (some heart medicines), or other medicines that may affect blood flow in the brain, except antidepressants. Medicines that work will not be stopped for this study.
  • You have eye problems or trouble seeing even with glasses or contact lenses.

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

Official eligibility criteria

Inclusion Criteria: * ages 18 - 55 * primary diagnosis of MDD and are currently depressed * able to give written informed consent prior to participation * unmedicated OR are stable on an antidepressant regime (at least 4 weeks to ensure symptoms are stable). Effective medications will not be discontinued for the purposes of the study. Exclusion Criteria: * clinically significant or unstable cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder * Current severe DSM-V alcohol or substance use disorder, with the exception of nicotine or caffeine. Clinician will access subjects' alcohol and substance use on a case-by-case to determine whether specific cases of mild or moderate alcohol or substance use would also interfere with the effects of the intervention. * history of traumatic brain injury * unable to complete MRI scan due to claustrophobia or general MRI exclusions (e.g., shrapnel inside body) * currently pregnant or breast feeding * unable to complete questionnaires written in English * current (within 3 weeks of testing) use of any antipsychotics, anticonvulsants, stimulants, benzodiazepines, beta-blockers, or other medications (except antidepressants) likely to influence cerebral blood flow. Effective medications will not be discontinued for the purposes of the study. * diagnosis of psychotic or organic mental disorder, bipolar I or II disorder. * eye problems or difficulties in corrected vision.

Study sites (1)

PA