RecruitingDepression
Apimostinel + Automated Neurocognitive Training for Depression
Eligible age
18–60 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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
You may qualify if…
- ✓ 1. Participants of any gender are eligible
- ✓ 2. Aged 18 to 60 years
- ✓ 3. Meets Diagnostic and Statistical Manual, Fifth Edition (DSM-V) criteria for major depressive disorder (MDD)
- ✓ 4. MADRS score ≥ 20 at screening
- ✓ 5. 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
- ✓ 6. 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.
- ✓ 7. 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.
- ✓ 8. Clinical laboratory values \< 1.5 times the upper limit of normal (ULN) or deemed not clinically significant per the investigator
You may not qualify if…
- ✕ 1. Presence of lifetime bipolar, psychotic, or autism spectrum; or current problematic, moderate-to-severe substance use disorder
- ✕ 2. Use of a Monoamine Oxidase Inhibitor (MAOI) within 28 days of infusion date
- ✕ 3. 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
- ✕ 4. Currently hospitalized or residing in an in-patient facility during the study participation
- ✕ 5. 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.
- ✕ 6. Changes made to treatment regimen within 28 days of drug infusion (Day 0)
- ✕ 7. Reading level \<6th grade as per patient self-report
- ✕ 8. 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.
Where it's recruiting
Pennsylvania
Pittsburgh
Source: ClinicalTrials.gov · NCT06400121 · last updated 2026-08-10