Depression
Conditions
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.
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
Sponsors
Rebecca Price
Syndeio Biosciences, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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 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 9. 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 10. 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 to major depressive episodes are permitted.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) | Trajectories from baseline/screening through 5 days post infusion | interviewer-rated depression severity, comparing both apimostinel arms (collapsing active and sham CT arms) to placebo+CT arm; range 0-60; high score=worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quick Inventory of Depressive Symptoms | Trajectories from baseline/screening through 45 days post infusion | Self-reported depression (range: 0-27; higher scores = worse outcome) |
| Montgomery-Asberg Depression Rating Scale (MADRS) | Trajectories from baseline/screening through 6 months post infusion | interviewer-rated depression severity; range 0-60; high score=worse outcome |
Countries
United States
Contacts
CONTACTRebecca B Price, PhD
CONTACTCrystal Spotts, M.Ed.
PRINCIPAL_INVESTIGATORRebecca B Price, PhD
University of Pittsburgh
Outcome results
None listed