Apimostinel Infusion, Intravenous / Isotonic Solution, Intravenous / Depression · Phase 2 Trial

Apimostinel + Automated Neurocognitive Training for Depression

ClinicalTrials.gov · August 10, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 2 randomized controlled trial registered at ClinicalTrials.gov (NCT06400121) that is currently recruiting to evaluate apimostinel (an experimental rapid-acting antidepressant) combined with automated cognitive training for depression treatment. No results are yet available in this registry record; the study is designed to measure MADRS trajectories over 5 and 45 days post-infusion and to test whether cognitive training can enhance or extend treatment durability.

What was studied

Phase 2, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Depression; age from 18 Years; to 60 Years. Intervention: Apimostinel + Cognitive Training. Compared with: Apimostinel + Sham Training — Sham Comparator; Placebo + Cognitive Training — Placebo Comparator. n = 150. 1 site: United States.

Key findings

Safety

This is a registry record only; no results, outcome data, or safety findings are reported.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

Phase 2 interventional trial with estimated enrollment; no results posted in this registry record; design is sound but study is still recruiting and outcome data are not yet reported.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Montgomery-Asberg Depression Rating Scale (MADRS) (assessed at Trajectories from baseline/screening through 5 days post infusion); Montgomery-Asberg Depression Rating Scale (MADRS) (assessed at Trajectories from baseline/screening through 45 days post infusion)

DesignPhase 2, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationDepression; age from 18 Years; to 60 Years

Sample size150

InterventionApimostinel + Cognitive Training

ComparatorApimostinel + Sham Training — Sham Comparator; Placebo + Cognitive Training — Placebo Comparator

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment150

Study phasePHASE 2

Primary outcome measure 1MADRS trajectories baseline/screening through 5 days post-infusion

Primary outcome measure 2MADRS trajectories baseline/screening through 45 days post-infusion

Caveats

This is a registry record only; no results, outcome data, or safety findings are reported.
Recruitment is ongoing; study enrollment, completion, and results status unknown.
Blinding, allocation concealment, and detailed study conduct are not described in this registry entry.
Study is Phase 2; not powered for definitive efficacy claims or clinical practice recommendations.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Randomized controlled trial with active drug, placebo, and behavioral comparators.

Directness

strong

Primary outcomes directly measure depression severity trajectories via MADRS.

Consistency

insufficient

Registry record only; no results reported for consistency assessment.

Risk of bias

insufficient

No methods detail on blinding, allocation concealment, or conduct reported here.

Sample adequacy

limited

Estimated 150 participants; Phase 2 trial, not powered for definitive efficacy claim.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06400121). This is a study registration, not published results. Lead sponsor: Rebecca Price. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 150 participants (ESTIMATED). Conditions: Depression. Interventions: DRUG: Apimostinel Infusion, Intravenous; BEHAVIORAL: Cognitive Training; BEHAVIORAL: Sham Training; DRUG: Isotonic Solution, Intravenous. Primary outcome measures: Montgomery-Asberg Depression Rating Scale (MADRS) , Trajectories from baseline/screening through 5 days post infusion; Montgomery-Asberg Depression Rating Scale (MADRS) , Trajectories from baseline/screening through 45 days post infusion. Brief summary: 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Rebecca PriceApimostinel Infusion, IntravenousIsotonic Solution, IntravenousDepressionCognitive TrainingNCT06400121Sham Training