Phase 2, Randomized, Double-Blind, Placebo-Controlled, Single Intravenous Dose, Parallel Efficacy Study of Apimostinel With or Without Subsequent Automated Self-Association Training in Subjects With Major Depressive Disorder
Rebecca Price
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.
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 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 contracept…
Interventions
- DrugApimostinel Infusion, Intravenous
Single injection of Apimostinel (10mg)
- BehavioralCognitive Training
8 sessions of digital active training
- BehavioralSham Training
8 sessions of digital sham training
- DrugIsotonic Solution, Intravenous
Single injection of placebo
Location
- Western Psychiatric Institute and ClinicPittsburgh, Pennsylvania