Health Trials

Apimostinel + Automated Neurocognitive Training for Depression

ConditionDepression
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorRebecca Price

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Participants of any gender are eligible

Aged 18 to 60 years

Meets Diagnostic and Statistical Manual, Fifth Edition (DSM-V) criteria for major depressive disorder (MDD)

MADRS score ≥ 20 at screening

Disqualifiers

Presence of lifetime bipolar, psychotic, or autism spectrum; or current problematic, moderate-to-severe substance use disorder

Use of a Monoamine Oxidase Inhibitor (MAOI) within 28 days of infusion date

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

Currently hospitalized or residing in an in-patient facility during the study participation

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Apimostinel + Cognitive TrainingExperimental treatment 2 interventions
Group B: Apimostinel + Sham TrainingSham comparator 2 interventions
Group C: Placebo + Cognitive TrainingPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Montgomery-Asberg Depression Rating Scale (MADRS)

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

Time frame
Trajectories from baseline/screening through 5 days post infusion
2

Montgomery-Asberg Depression Rating Scale (MADRS)

interviewer-rated depression severity, comparing apimostinel+CT to placebo+CT arm; range 0-60; high score=worse outcome

Time frame
Trajectories from baseline/screening through 45 days post infusion

Secondary outcomes

1

Quick Inventory of Depressive Symptoms

Self-reported depression (range: 0-27; higher scores = worse outcome)

Time frame
Trajectories from baseline/screening through 45 days post infusion
2

Quick Inventory of Depressive Symptoms

Self-reported depression (range: 0-27; higher scores = worse outcome)

Time frame
Trajectories from baseline/screening through 6 months post infusion
3

Montgomery-Asberg Depression Rating Scale (MADRS)

interviewer-rated depression severity; range 0-60; high score=worse outcome

Time frame
Trajectories from baseline/screening through 6 months post infusion

Other outcomes

1

Clinician-Administered Dissociative States Scale (CADSS)

Dissociative side effects; range=0-92; higher score=worse outcome

Time frame
Trajectories from baseline through 120 min post infusion
2

Brief Psychiatric Rating Scale--4 item psychosis subscale (BPRS+)

Psychotomimetic side effects; range=4-28; higher score=worse outcome

Time frame
Trajectories from baseline through 120 min post infusion
3

Time to onset of effect on MADRS

Defined as the first time the MADRS score is statistically significantly different from placebo group

Time frame
Assessed at each study visit from Day 1 to Month 6
4

Duration of effect on MADRS

Defined as the last time the MADRS score is statistically significantly different from placebo group

Time frame
Assessed at each study visit from Day 1 to Month 6

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rebecca Price

Lead sponsor

University of Pittsburgh

Sponsor institution

Syndeio Biosciences, Inc

Collaborator

Source ClinicalTrials.gov
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