Status:
NOT_YET_RECRUITING
Ultrasound Neuromodulation of Circuits and Negative Valence Systems in Treatment-Resistant Depression
Lead Sponsor:
Laureate Institute for Brain Research, Inc.
Conditions:
Treatment-Resistant Depression
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Approximately one third of individuals with Major Depressive Disorder (MDD) are considered treatment-resistant, subject to severe disability and risk of suicide, and exhibit symptoms anchored in abnor...
Detailed Description
Approximately one third of individuals with depression are considered treatment-resistant (TRD) and exhibit symptoms anchored in abnormalities of RDoC Negative Valence Systems behavioral processes. Fo...
Eligibility Criteria
Inclusion
- Persons 18-65 years old, with gender and ethnicity recruitment targets including a M:F proportion of 1:2 and White:Black:Hispanic:Native American proportion as close as possible to 8:2:2:1 to reflect the regional epidemiology of TRD (63% White American; 16% African American; 14% Hispanic of any race; 5% Native American),
- DSM-5-TR diagnosis of MDD as confirmed by MINI structured interview followed by consultation with a board-certified psychiatrist,
- Evidence of treatment resistance defined as continued MDD symptoms despite any of the following:
- two or more adequate (6 week) trials of antidepressants with different mechanisms,
- evidence-based psychotherapy,
- augmentation agent (lithium, atypical antipsychotic, or T3), or
- consideration of ECT or prior ECT nonresponse or intolerance,
- at least moderate symptoms as indicated by MADRS≥20 upon screening
- stable treatments including psychotherapy and medication for at least six weeks prior to participation.
- Fluent English speaker, capable of written consent
- Consent that random observations of pathology are possible (e.g., brain abnormality seen during imaging)
Exclusion
- Clinical history of at least minor neurocognitive disorder of neurodegenerative origin,
- PROMIS (Cognitive Function scale) score ≤40 (i.e., mean - 1SD), collected at baseline
- clinical history of relevant structural pathology of the central nervous system, including Parkinson's disease, multiple sclerosis, and brain malignant neoplasia,
- uncontrolled diabetes mellitus (as evidenced by a fasting glycemia ≥ 120 mg/dL or hemoglobin A1c ≥ 6.5%) or hypertension (as evidenced by two consecutive readings ≥ 140/90 mmHg) to ensure medical stability, collected at baseline
- pregnancy or lactation,
- Has positive test result(s) for alcohol or drugs of abuse (including methadone, opiates, cocaine, amphetamine/methamphetamine, and ecstasy), or substance use disorder including alcohol, stimulants, sedatives, and cannabis exceeding mild severity in the last 6 months,
- active suicidal ideation (as measured by Suicide-Risk-Assessment-C-SSRS75 "Yes" answers to items 3, 4 or 5 of Suicidal Ideation-Past 1 month section, or any "Yes" answer to any of the items of Suicidal Behavior-Past 3 months section), or any suicide attempt in the last 3 months, collected at baseline
- MRI contraindications as detected by the MRI Safety Screen, including unwillingness/unable to complete MRI scans
- medical history indicative of moderate to severe traumatic brain injury as evidenced by history of \> 5 minutes of loss of consciousness, or of skull fractures, which in theory could distort LIFU tissue propagation, and
- a current diagnosis of a psychotic disorder (e.g. schizophrenia, bipolar disorder), an eating disorder (e.g. anorexia or bulimia nervosa), learning disability, or a personality disorder that is considered by the investigator to interfere with the ability of the subject to adhere to the protocol (e.g., narcissistic personality disorder, borderline personality disorder).
- Has a history of moderate or severe substance or alcohol use disorder according to DSM-5-TR
- Use of benzodiazepines or anticonvulsants in the 7 days prior to screening
- Medical, psychiatric, or other conditions that restrict the patient's following abilities: to interpret the study information, to give informed consent, to adhere to the rules of the protocol, or to complete the study.
- No reliable method of communication (i.e., no access to internet or phone connection)
- Prescription of a medication outside of the accepted range, as determined by best clinical practices and current research
- Unwillingness or inability to complete any of the major aspects of the study protocol
- Non-correctable vision or hearing problems
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2030
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT07166289
Start Date
September 1 2025
End Date
July 1 2030
Last Update
September 22 2025
Active Locations (1)
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1
Laureate Institute for Brain Research
Tulsa, Oklahoma, United States, 74136