Is NCT07227103 recruiting in Sarasota, FL?

Yes, NCT07227103 is currently enrolling participants at its Sarasota, FL location. This treatment resistant depression clinical trial is accepting qualified participants.

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

To join this clinical trial in Sarasota, 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 Sarasota 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 Sarasota, FL: NRX-101

About This Treatment Resistant Depression Study in Sarasota

Major depressive disorder (MDD) is a significant public health problem and leading cause of worldwide disability. Treatment resistance is common in MDD, however, for these individuals, targeted noninvasive brain stimulation is an alternative. Repetitive transcranial magnetic stimulation (rTMS) and more recently, theta-burst stimulation (TBS), are the noninvasive brain stimulation modalities with the largest evidence base in MDD. Although efficacious, an unacceptable proportion of patients do not significantly improve, and several aspects of the TMS parameter space are under investigation to enhance clinical outcomes. This study will compare Rapid Robotically-guided Transcranial Magnetic Stimulation (RRTMS) combined with an investigational neuroplasticity-inducing medication (NRX-101) to the effects of (1) sham TMS treatment and (2) placebo in achieving clinical response and remission from depression in patients with Treatment Resistant Depression. DCS has been shown in a randomized trial of more than double the percent response and remission from traditional TMS. When a one day (ONE-D) TMS protocol was combined with DCS, the measured response rate was 87% at one week. This trial will compare response and remission at six weeks following neuronavigated robotic-enabled Transcranial Magnetic Stimulation + NRX-101 (D-cycloserine/lurasidone) vs. TMS+placebo.

Sponsor: NeuroRx, Inc.

Who Can Participate

Inclusion Criteria

in this study Heterosexual female of childbearing potential who is not willing to use one of the specified forms of birth control during the study. 2. Female who is pregnant (positive pregnancy test at Screening) or breastfeeding. 3. Active suicidality (without the intention to act) as evidenced by a score of \>3 on the Columbia Suicide Severity Rating Scale. 4. Current DSM-5 diagnosis of moderate or severe substance use disorder (except marijuana or tobacco use disorder) within the 12 months prior to Screening. (Note: Substance use disorder cannot be the precipitant for study entry). 5. Current DSM-5 diagnosis of alcohol use disorder 6. A lifetime history of phencyclidine (PCP)/ketamine drug abuse 7. History of schizophrenia or schizoaffective disorder 8. History of anorexia nervosa, bulimia nervosa, eating disorder not otherwise specified (NOS), or other specified feeding and eating disorders (OSFED) within 3 years of Screening. 9. Has dementia, delirium, amnestic, or any other cognitive disorder. 10. Renal impairment defined as estimated glomerular filtration rate (eGFR) \< 60 mL/min, calculated using the 2021 CKD-EPI creatinine equation (racefree). 11. Clinically significant hepatic impairment. Clinically significant hepatic impairment is defined as a history of chronic liver disease (e.g., cirrhosis, chronic hepatitis, alcoholic liver disease, nonalcoholic steatohepatitis) or evidence at Screening of acute liver disease or impaired liver function (e.g., ALT or AST \>3 × ULN, total bilirubin \>2 × ULN) or in the opinion of the Investigator. 12. A clinically significant abnormality on the Screening physical examination that may affect safety or study participation, or that may confound interpretation of study results according to the study clinician. 13. Risk factors for neurocardiogenic syncope including history of syncope/ presyncope related to noxious stimuli, anxiety, micturation, or posture. 14. Co-morbidities as ascertained by medical history, physical examination (including measurement of vital signs), clinical laboratory evaluations, and electrocardiogram (ECG) which might interfere with compliance or the ability to assess efficacy or safety. 15. Diagnosis of moderate to severe heart disease or current episode of:

Myocardial infarction within 1 year of Screening.

Diagnosis of angina pectoris.

Prolonged QTc interval, as measured by Fridericia's correction formula (QTcF) ≥450 msec at Screening for males or ≥ 470 msec for females on 2 of 3 measurements at least 15 minutes apart prior to randomization on Day 1. 16. Diagnosis of chronic lung disease, excluding asthma. 17. Lifetime history of any of the following: neurologic conditions with structural cerebral damage, traumatic brain injury, multiple sclerosis, surgical procedures involving the brain or meninges, meningoencephalitis, degenerative central nervous system (CNS) disorder (e.g., Alzheimer's Disease, Parkinson's Disease), mental retardation, stroke (ischemic or hemorrhagic), intracranial abscess, or any other disease/procedure/accident/intervention that, according to the clinician, is deemed associated with significant injury to, or malfunction of, the CNS. 18. History of epilepsy, personal history of seizure, family history of epilepsy or seizure in a first degree relative. 19. Diagnosis of parenchymal or leptomeningeal cancer. Diabetes mellitus fulfilling any of the following criteria:

Unstable diabetes mellitus defined as glycosylated hemoglobin (HbA1c) \>8.0 percent at Screening.

Admitted to the hospital for treatment of diabetes mellitus or diabetes mellitus-related illness in the past 12 weeks.

Not under physician care for diabetes mellitus.

Not on the same dose of oral hypoglycemic drug(s) and/or diet for the 4 weeks prior to Screening. 180645 180645 Protocol NRX101-011\_ MIND1 V3.0 FINAL Pg. 8 NRX101-011 Protocol v3.0 9 Confidential

Exclusion Criteria

A patient is ineligible for inclusion in this study Heterosexual female of childbearing potential who is not willing to use one of the specified forms of birth control during the study. 2. Female who is pregnant (positive pregnancy test at Screening) or breastfeeding. 3. Active suicidality (without the intention to act) as evidenced by a score of \>3 on the Columbia Suicide Severity Rating Scale. 4. Current DSM-5 diagnosis of moderate or severe substance use disorder (except marijuana or tobacco use disorder) within the 12 months prior to Screening. (Note: Substance use disorder cannot be the precipitant for study entry). 5. Current DSM-5 diagnosis of alcohol use disorder 6. A lifetime history of phencyclidine (PCP)/ketamine drug abuse 7. History of schizophrenia or schizoaffective disorder 8. History of anorexia nervosa, bulimia nervosa, eating disorder not otherwise specified (NOS), or other specified feeding and eating disorders (OSFED) within 3 years of Screening. 9. Has dementia, delirium, amnestic, or any other cognitive disorder. 10. Renal impairment defined as estimated glomerular filtration rate (eGFR) \< 60 mL/min, calculated using the 2021 CKD-EPI creatinine equation (racefree). 11. Clinically significant hepatic impairment. Clinically significant hepatic impairment is defined as a history of chronic liver disease (e.g., cirrhosis, chronic hepatitis, alcoholic liver disease, nonalcoholic steatohepatitis) or evidence at Screening of acute liver disease or impaired liver function (e.g., ALT or AST \>3 × ULN, total bilirubin \>2 × ULN) or in the opinion of the Investigator. 12. A clinically significant abnormality on the Screening physical examination that may affect safety or study participation, or that may confound interpretation of study results according to the study clinician. 13. Risk factors for neurocardiogenic syncope including history of syncope/ presyncope related to noxious stimuli, anxiety, micturation, or posture. 14. Co-morbidities as ascertained by medical history, physical examination (including measurement of vital signs), clinical laboratory evaluations, and electrocardiogram (ECG) which might interfere with compliance or the ability to assess efficacy or safety. 15. Diagnosis of moderate to severe heart disease or current episode of:

Myocardial infarction within 1 year of Screening.

Diagnosis of angina pectoris.

Unstable diabetes mellitus defined as glycosylated hemoglobin (HbA1c) \>8.0 percent at Screening.

Admitted to the hospital for treatment of diabetes mellitus or diabetes mellitus-related illness in the past 12 weeks.

Not under physician care for diabetes mellitus.

Not on the same dose of oral hypoglycemic drug(s) and/or diet for the 4 weeks prior to Screening. 180645 180645 Protocol NRX101-011\_ MIND1 V3.0 FINAL Pg. 8 NRX101-011 Protocol v3.0 9 Confidential

Not on the same dose of oral thiazolidinediones (glitazones) for the 8 weeks prior to Screening. 21. Any current or past history of any physical condition which, in the opinion of the investigator, may put the patient at risk or interfere with study results interpretation. 22. On exclusionary concomitant psychotropic and non-psychotropic medications (see Section 9.5) 23. Prescribed more than one agent in each of the following categories at randomization: a. Approved SSRIs. b. Approved serotonin and norepinephrine reuptake inhibitors (SNRIs). c. Approved tetracyclic antidepressants (TeCAs). 24. Currently prescribed oxcarbazepine or carbamazepine. 25. Exclusionary laboratory values or any other clinically significant abnormal laboratory result at Screening. Within normal limits (WNL) will be determined based on lab values of the local lab used. 26. Known allergies to lurasidone or Latuda®, cycloserine or Seromycin®, or the following excipients: mannitol, croscarmellose sodium, magnesium stearate, silicon dioxide, and/or hydroxypropylmethylcellulose (HPMC). 27. Participation in any clinical trial with an investigational drug or device within the past 3 months or planned concurrent study participation. 28. Study site personnel and/or persons employed by NRx Pharma, Inc., the Contract Research Organization (CRO), the investigator, or study site (i.e., permanent, temporary contract worker, or designee responsible for the conduct of the study), or an immediate family member (i.e., spouse, parent, child, or sibling \[biological or legally adopted\]) of such persons. Positive urine toxicity screening for use of any cocaine, opiates, nonprescribed amphetamines, or non-prescribed barbiturates. (Note: cannabinoids or marijuana use is not exclusionary, unless patient meets the DSM-5 criteria for cannabis withdrawal). 30. Patients with pacemakers and/or any implants including metal in the head except the mouth (cochlear implant, implanted brain stimulators, aneurysm clips) 31. Individuals with an intracranial lesion or increased intracranial pressure

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 Sarasota?

Yes, this clinical trial (NCT07227103) has an active research site in Sarasota, FL 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 Sarasota, FL

If you're searching for treatment resistant depression treatment options in Sarasota, FL, this clinical trial (NCT07227103) 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 Sarasota research site is actively enrolling participants for this phase 2/3 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 Sarasota, FL

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