Apimostinel + Automated Neurocognitive Training for Depression

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Rebecca Price
Study ID
NCT06400121
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Apimostinel Infusion, Intravenous — DRUG
    Single injection of Apimostinel (10mg)
  • Cognitive Training — BEHAVIORAL
    8 sessions of digital active training
  • Sham Training — BEHAVIORAL
    8 sessions of digital sham training
  • Isotonic Solution, Intravenous — DRUG
    Single injection of placebo

Study Details

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.

Key Dates

Start date
Oct 28, 2024
Status verified
Sep 2025
Primary completion
Mar 1, 2029
Completion
Dec 1, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apimostinel + Cognitive Training
  • Sham Comparator: Apimostinel + Sham Training
  • Placebo Comparator: Placebo + Cognitive Training

Primary Outcome Measure

Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Trajectories from baseline/screening through 5 days post infusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Western Psychiatric Institute and ClinicPittsburghPennsylvania15213
Rebecca Price, PhD
[email protected]
412-648-6445

Find similar trials in Pittsburgh, PA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Western Psychiatric Institute and Clinic· Pittsburgh, PA

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