Neurofeedback treatment for patients with depression who don't respond to standard therapies
Amygdala rtfMRI Neurofeedback for Treatment Resistant Depression
This study is testing a new type of brain training to see if it can help people with depression who haven't responded to regular treatments feel better by improving their emotional reactions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT03428828 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) training to enhance the amygdala's response to positive memories in individuals suffering from treatment-resistant major depressive disorder (TR-MDD). The trial will involve 100 participants who will be randomly assigned to receive either amygdala-focused neurofeedback or a control intervention targeting a non-emotional brain region. The researchers will measure changes in amygdala activity and clinical symptoms to determine the efficacy of this innovative approach. The study seeks to address the underlying mechanisms of TR-MDD by improving emotional reactivity through neurofeedback training.
Who should consider this trial
Good fit: Ideal candidates for this study are right-handed adults aged 18 to 55 with a primary diagnosis of recurrent major depressive disorder who have not responded to standard treatments.
Not a fit: Patients with unstable medical conditions or those who have a history of substance dependence may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel therapeutic option for patients with treatment-resistant depression, potentially leading to significant improvements in their symptoms.
How similar studies have performed: Previous studies have shown promising results using neurofeedback techniques in depression, suggesting potential for success in this novel application for treatment-resistant cases.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * right-handed adults (ages 18 - 55) with a primary diagnosis of MDD according to diagnostic criteria DSM-5 for recurrent MDD who are currently depressed will be recruited to participate * must be able to give written informed consent prior to participation * must have fewer than 45% memories categorized as specific on the Autobiographical Memory Test * must have a SHAPS score \> 4, indicating the presence of anhedonia * unmedicated or stable on an SSRI antidepressant regime (at least 3 weeks to ensure symptoms are stable) * previously failed to respond to two previous SSRI medications according to either a medical record review or clinical interview during Visit 1 Exclusion Criteria: * have a clinically significant or unstable cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder * met DSM-IV criteria for alcohol and/or substance dependence (other than nicotine) within 12 months prior to screening * have a history of traumatic brain injury * are unable to complete MRI scan due to claustrophobia or general MRI exclusions (e.g., shrapnel inside body) * are currently pregnant or breast feeding * are 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 SSRI antidepressants) likely to influence cerebral blood flow. Effective medications will not be discontinued for the purposes of the study. Inclusion of patients on stable antidepressant medications was decided in order to allow generalization towards a real world population * have a DSM-5 diagnosis of psychotic or organic mental disorder, bipolar I or II disorder or any past or current manic or hypomanic symptoms, autism, or a primary diagnosis of an anxiety disorder (though co-morbid anxiety will not be excluded) * have any eye problems or difficulties in corrected vision.
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Kymberly Young, PhD — University of Pittsburgh
- Study coordinator: Scott Barb
- Email: barbsm3@upmc.edu
- Phone: 412-648-6809
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.