Is NCT07166289 recruiting in Tulsa, OK?

Yes, NCT07166289 is currently recruiting participants at its Tulsa, OK location. This treatment-resistant depression clinical trial is actively enrolling qualified participants.

How do I join the treatment-resistant depression clinical trial in Tulsa?

To join this clinical trial in Tulsa, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Tulsa clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Treatment-Resistant Depression Clinical Trial in Tulsa, OK

About This Treatment-Resistant Depression Study in Tulsa

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 abnormalities of Research Domain Criteria (RDoC) Negative Valence Systems behavioral processes. In the present study we plan to use low-intensity focused ultrasound in 120 persons with treatment-resistant MDD to modulate deep white matter tracts connecting the thalamus and different regions of the prefrontal cortex reversibly and non-invasively, with the aim of assigning a causal, mechanistic role to large scale brain circuits in the production of those critical behavioral abnormalities. A successful study will help to attain the precise definition of neuromodulation targets for this clinical population in utter need of help.

Sponsor: Laureate Institute for Brain Research, Inc.

Who Can Participate

Inclusion Criteria

Persons 18-65 years old, with sex 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 Criteria

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 ot 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

Unwilligness or inability to complete any of the major aspects of the study protocol

Non-correctable vision or hearing problems

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Tulsa?

Yes, this clinical trial (NCT07166289) has an active research site in Tulsa, OK that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Treatment-Resistant Depression Treatment Options in Tulsa, OK

If you're searching for treatment-resistant depression treatment options in Tulsa, OK, this clinical trial (NCT07166289) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Tulsa research site is actively enrolling participants for this clinical trial. You'll receive care from experienced treatment-resistant depression specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all treatment-resistant depression clinical trials near you to find additional studies recruiting in your area.

Treatment-Resistant Depression Clinical Trial in Tulsa, OK

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