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New treatment option for Depression
Official title Apimostinel + Automated Neurocognitive Training for Depression
ClinicalTrials.gov ID: NCT06400121
What this study is testing
What is Apimostinel Infusion, Intravenous?
Apimostinel Infusion, Intravenous is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for depression.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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...
You likely can't join if
- 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...
- Changes made to treatment regimen within 28 days of drug infusion (Day 0)
See the full eligibility criteria
Who can join
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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) \ 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...
- 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]...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.