Is NCT06400121 recruiting in Pittsburgh, PA?

Yes, NCT06400121 is currently recruiting participants at its Pittsburgh, PA location. This depression clinical trial is actively enrolling qualified participants.

How do I join the depression clinical trial in Pittsburgh?

To join this clinical trial in Pittsburgh, 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 Pittsburgh 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.

Depression Clinical Trial in Pittsburgh, PA

About This Depression Study in Pittsburgh

Apimostinel shows initial promise as a novel rapid-acting antidepressant medication with minimal side effects or safety concerns. Cognitive Training (CT) is a digital intervention that has shown promise in extending the durability of another similar drug (ketamine). This randomized controlled trial will test the efficacy and safety of apimostinel (vs. placebo) for the acute treatment of depression, and will test the potential of CT to enhance and/or extend the durability of apimostinel's antidepressant effect.

Sponsor: Rebecca Price

Who Can Participate

Inclusion Criteria

Participants of any gender are eligible

Aged 18 to 60 years

Meets Diagnostic and Statistical Manual, Fifth Edition (DSM-V) criteria for major depressive disorder (MDD)

MADRS score ≥ 20 at screening

Score \>1SD above the normative mean on the Cognitive Triad Inventory (CTI) "self" subscale \*OR\

\<1SD below the normative mean on the Rosenberg self-esteem scale

Participants of childbearing potential with a negative serum pregnancy test prior to entry into the study and who are practicing an adequate method of birth control (eg oral or parenteral contraceptives, intrauterine device, barrier, abstinence) and who do not plan to become pregnant during the course of the study. Participants may be included without a negative serum pregnancy test if they are surgically sterile or at least 2 years post- menopausal. Participants who could impregnate a sexual partner should use an acceptable method of birth control during the study, from the day of dosing to 28 days following dose.

Participants who could impregnate a partner and their sexual partner of childbearing potential should use an acceptable method of birth control during the study, from day of dosing to 28 days following dose.

Clinical laboratory values \< 1.5 times the upper limit of normal (ULN) or deemed not clinically significant per the investigator

Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments

Based on the investigator's clinical judgment, participants with eating disorders, obsessive compulsive disorder (OCD), panic disorder, post-traumatic stress disorder (PTSD), and generalized anxiety disorders secondary to major depressive episodes are permitted.

Exclusion Criteria

Presence of lifetime bipolar, psychotic, or autism spectrum; or current problematic, moderate-to-severe substance use disorder

Use of a Monoamine Oxidase Inhibitor (MAOI) within 28 days of infusion date

Huntington's, Parkinson's, Alzheimer's, Multiple Sclerosis, or a history of strokes or with one or more seizures without a clear and resolved etiology

Currently hospitalized or residing in an in-patient facility during the study participation

Acute suicidality or other psychiatric crises requiring treatment escalation, using the Columbia-Suicide Severity Rating Scale (C-SSRS) as both an initial exclusion criteria (C-SSRS "Baseline/Screening" Version for past 1-month period) and as grounds for rescue/removal (C-SSRS "Since Last Visit" form). Participants with C-SSRS suicide ideation scores scored "yes" on items 4 (active suicidal ideation with some intent to act) and/or 5 (active suicidal ideation with specific plan and intent) will be excluded from the study, and if enrolled, will be exited from the study and referred immediately to the nearest emergency mental health facility for additional thorough assessment and appropriate treatment referral.

Changes made to treatment regimen within 28 days of drug infusion (Day 0)

Reading level \<6th grade as per patient self-report

Serious, unstable medical illnesses including respiratory \[obstructive sleep apnea, or history of difficulty with airway management during previous anesthetics\], cardiovascular \[including ischemic heart disease and uncontrolled hypertension\], and neurologic \[including history of severe head injury diagnoses.

Clinically significant abnormal findings of laboratory parameters \[including urine toxicology screen for drugs of abuse\], physical examination, or ECG.

Uncontrolled or poorly controlled hypertension, as determined by the study physician's review of vitals collected during screening and any other relevant medical history/records.

Patient has clinically significant renal dysfunction as assessed by the estimated glomerular filtration rate \<70 mL/min using the Chronic Kidney Disease Epidemiology Collaboration -creatinine methodology.

Patient has liver enzyme test results \>2 times the upper limit of normal.

Patient has resting heart rate (supine) \<60 or \>100 bpm at the Screening Visit or Pre-Dose Baseline, in the absence of an etiology that, in the judgment of the investigator, is related to exceptionally good cardiovascular fitness.

Patient has PR interval \>250 msec at the Screening Visit or Pre-Dose Baseline

Patients starting hormonal treatment (e.g., estrogen) in the 3 months prior to Screening.

Patients taking medications with known activity at the NMDA or AMPA glutamate receptor \[e.g., riluzole, amantadine, memantine, topiramate, dextromethorphan (including AuvelityTM), D-cycloserine, ketamine or esketamine\], or the mu-opioid receptor.

Patients taking any of the following medications: St John's Wort, theophylline, tramadol, metrizamide.

Patients who have received ECT in the past 6 months prior to Screening.

Patients currently receiving treatment with vagus nerve stimulation (VNS) or repetitive transcranial stimulation (rTMS).

Participation in any clinical trial of an investigational product or device within 30 days of enrollment in this trial

Positive screen for unreported drugs of abuse, including: cocaine, PCP, opioid or other agent that in the opinion of the investigator is being abused. Positive marijuana screen is not exclusionary if use is consistent with clinical diagnostic interview findings and is seen in the absence of a moderate-to-severe substance use disorder.

Participants or sexual partners of participants who are currently pregnant or planning to become pregnant during the course of the study

Participants who are breastfeeding

History of allergy, sensitivity, or intolerance to apimostinel, zelquistinel, NMDAR ligands including ketamine,dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone.

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 Pittsburgh?

Yes, this clinical trial (NCT06400121) has an active research site in Pittsburgh, PA 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.

Depression Treatment Options in Pittsburgh, PA

If you're searching for depression treatment options in Pittsburgh, PA, this clinical trial (NCT06400121) 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 Pittsburgh research site is actively enrolling participants for this clinical trial. You'll receive care from experienced 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 depression clinical trials near you to find additional studies recruiting in your area.

Depression Clinical Trial in Pittsburgh, PA

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