DepressionPhase 2NCT06400121
Apimostinel + Automated Neurocognitive Training for Depression
A Phase 2 study testing Apimostinel Infusion, Intravenous, Cognitive Training and Isotonic Solution, Intravenous in people with Depression, run by Rebecca Price at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression
- What is being tested?
- Apimostinel Infusion, Intravenous, Cognitive Training and Isotonic Solution, Intravenous
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2024to 1 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
- 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
- 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.
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- 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.
- Clinical laboratory values < 1.5 times the upper limit of normal (ULN) or deemed not clinically significant per the investigator
- 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
- 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.
Who cannot join
- 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
- Acute suicidality or other psychiatric crises requiring treatment escalation, using the Columbia-Suicide Severity Rating Scale (C-SSRS) as both an initial exclusion criteria (C-SSRS "Baseline/Screening" Version for past 1-month period) and as grounds for rescue/removal (C-SSRS "Since Last Visit" form). Participants with C-SSRS suicide ideation scores scored "yes" on items 4 (active suicidal ideation with some intent to act) and/or 5 (active suicidal ideation with specific plan and intent) will be excluded from the study, and if enrolled, will be exited from the study and referred immediately to the nearest emergency mental health facility for additional thorough assessment and appropriate treatment referral.
- Changes made to treatment regimen within 28 days of drug infusion (Day 0)
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- Reading level <6th grade as per patient self-report
- Serious, unstable medical illnesses including respiratory [obstructive sleep apnea, or history of difficulty with airway management during previous anesthetics], cardiovascular [including ischemic heart disease and uncontrolled hypertension], and neurologic [including history of severe head injury diagnoses.
- Clinically significant abnormal findings of laboratory parameters [including urine toxicology screen for drugs of abuse], physical examination, or ECG.
- Uncontrolled or poorly controlled hypertension, as determined by the study physician's review of vitals collected during screening and any other relevant medical history/records.
- Patient has clinically significant renal dysfunction as assessed by the estimated glomerular filtration rate <70 mL/min using the Chronic Kidney Disease Epidemiology Collaboration -creatinine methodology.
- Patient has liver enzyme test results >2 times the upper limit of normal.
- Patient has resting heart rate (supine) <60 or >100 bpm at the Screening Visit or Pre-Dose Baseline, in the absence of an etiology that, in the judgment of the investigator, is related to exceptionally good cardiovascular fitness.
- Patient has PR interval >250 msec at the Screening Visit or Pre-Dose Baseline
- Patients starting hormonal treatment (e.g., estrogen) in the 3 months prior to Screening.
- Patients taking medications with known activity at the NMDA or AMPA glutamate receptor [e.g., riluzole, amantadine, memantine, topiramate, dextromethorphan (including AuvelityTM), D-cycloserine, ketamine or esketamine], or the mu-opioid receptor.
- Patients taking any of the following medications: St John's Wort, theophylline, tramadol, metrizamide.
- Patients who have received ECT in the past 6 months prior to Screening.
- Patients currently receiving treatment with vagus nerve stimulation (VNS) or repetitive transcranial stimulation (rTMS).
- Participation in any clinical trial of an investigational product or device within 30 days of enrollment in this trial
- Positive screen for unreported drugs of abuse, including: cocaine, PCP, opioid or other agent that in the opinion of the investigator is being abused. Positive marijuana screen is not exclusionary if use is consistent with clinical diagnostic interview findings and is seen in the absence of a moderate-to-severe substance use disorder.
- Participants or sexual partners of participants who are currently pregnant or planning to become pregnant during the course of the study
- Participants who are breastfeeding
- History of allergy, sensitivity, or intolerance to apimostinel, zelquistinel, NMDAR ligands including ketamine,dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213
Rebecca Price, PhD, 412-648-6445, canlab@pitt.edu
About this study
Official title: 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
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.
- Conditions
- Depression
- Being tested
- Apimostinel Infusion, Intravenous, Cognitive Training, Sham Training, Isotonic Solution, Intravenous
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apimostinel Infusion, IntravenousDrug
Single injection of Apimostinel (10mg)
Cognitive TrainingBehavioural
8 sessions of digital active training
Sham TrainingBehavioural
8 sessions of digital sham training
Isotonic Solution, IntravenousDrug
Single injection of placebo
| Study group | Role | What they receive |
|---|---|---|
| Apimostinel + Cognitive Training | Experimental | Not described Receives: Drug: Apimostinel Infusion, Intravenous; Behavioral: Cognitive Training |
| Apimostinel + Sham Training | Sham comparator | Not described Receives: Drug: Apimostinel Infusion, Intravenous; Behavioral: Sham Training |
| Placebo + Cognitive Training | Placebo comparator | Not described Receives: Behavioral: Cognitive Training; Drug: Isotonic Solution, Intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Trajectories from baseline/screening through 5 days post infusion
Montgomery-Asberg Depression Rating Scale (MADRS)
interviewer-rated depression severity, comparing apimostinel+CT to placebo+CT arm; range 0-60; high score=worse outcome
Measured: Trajectories from baseline/screening through 45 days post infusion
Secondary outcomes (3)
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Measured: Trajectories from baseline/screening through 45 days post infusion
Quick Inventory of Depressive Symptoms
Self-reported depression (range: 0-27; higher scores = worse outcome)
Measured: Trajectories from baseline/screening through 6 months post infusion
Montgomery-Asberg Depression Rating Scale (MADRS)
interviewer-rated depression severity; range 0-60; high score=worse outcome
Measured: Trajectories from baseline/screening through 6 months post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start28 Oct 2024
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rebecca Price
- Sponsor type
- University, hospital or other
- Collaborators
- Syndeio Biosciences, Inc
- Responsible party
- Sponsor-investigator, Rebecca Price, University of Pittsburgh
- Investigators
- Rebecca B Price, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400121
- Sponsor's protocol ID
- STUDY24010064
- Status last verified
- Aug 2026
- First submitted
- 1 May 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06400121
- Acronym / sponsor ID
- STUDY24010064
- Conditions
- Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Rebecca PriceUniversity, hospital or other
- Collaborators
- Syndeio Biosciences, Inc
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Apimostinel + Cognitive Training | Experimental | Drug: Apimostinel Infusion, Intravenous, Behavioral: Cognitive Training |
| Apimostinel + Sham Training | Sham comparator | Drug: Apimostinel Infusion, Intravenous, Behavioral: Sham Training |
| Placebo + Cognitive Training | Placebo comparator | Behavioral: Cognitive Training, Drug: Isotonic Solution, Intravenous |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
- 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
Key exclusion criteria (24 listed)
- 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
- Acute suicidality or other psychiatric crises requiring treatment escalation, using the Columbia-Suicide Severity Rating Scale (C-SSRS) as both an initial exclusion criteria (C-SSRS "Baseline/Screening" Version for past 1-month period) and as grounds for rescue/removal (C-SSRS "Since Last Visit" form). Participants with C-SSRS suicide ideation scores scored "yes" on items 4 (active suicidal ideation with some intent to act) and/or 5 (active suicidal ideation with specific plan and intent) will be excluded from the study, and if enrolled, will be exited from the study and referred immediately to the nearest emergency mental health facility for additional thorough assessment and appropriate treatment referral.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apimostinel Infusion, IntravenousSingle injection of Apimostinel (10mg) | Drug | Apimostinel + Cognitive Training, Apimostinel + Sham Training |
| Cognitive Training8 sessions of digital active training | Behavioural | Apimostinel + Cognitive Training, Placebo + Cognitive Training |
| Sham Training8 sessions of digital sham training | Behavioural | Apimostinel + Sham Training |
| Isotonic Solution, IntravenousSingle injection of placebo | Drug | Placebo + Cognitive Training |
Primary outcome
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 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
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Trajectories from baseline/screening through 45 days post infusion
interviewer-rated depression severity, comparing apimostinel+CT to placebo+CT arm; range 0-60; high score=worse outcome
3 secondary outcomes
Quick Inventory of Depressive Symptoms
Time frame: Trajectories from baseline/screening through 45 days post infusion
Quick Inventory of Depressive Symptoms
Time frame: Trajectories from baseline/screening through 6 months post infusion
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Trajectories from baseline/screening through 6 months post infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rebecca B Price, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apimostinel Infusion, Intravenous, Cognitive Training and Isotonic Solution, Intravenous in people with Depression, run by Rebecca Price at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca B Price, PhD (4123832150, canlab@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: Trajectories from baseline/screening through 5 days post infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.