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NMDA receptor antagonist

Cohort 1, Apimostinel for Depression

Phase 1
Waitlist Available
Led By Ronald M Burch, MD PhD
Research Sponsored by Gate Neurosciences, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights

Study Summary

This trial tests a new drug to check how safe, tolerable and effective it is in healthy people.

Eligible Conditions
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Treatment Emergent Adverse Events
Secondary outcome measures
Pharmacokinetics - Maximum Plasma Concentration
Other outcome measures
EEG - Power
Event related potential (ERP)

Trial Design

10Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 5, Apimostinel, 25 mg IV, 8 consecutive daily dosesExperimental Treatment1 Intervention
Apimostinel, 25 mg IV 8 consecutive daily doses
Group II: Cohort 4, Apimostinel, 10 mg IV 8 consecutive daily dosesExperimental Treatment1 Intervention
Apimostinel, 10 mg IV 8 consecutive daily doses
Group III: Cohort 3, Apimostinel, 5 mg IV 8 consecutive daily dosesExperimental Treatment1 Intervention
Apimostinel, 5 mg IV 8 consecutive daily doses
Group IV: Cohort 2, Apimostinel, 1 mg IV 8 consecutive daily dosesExperimental Treatment1 Intervention
Apimostinel, 1 mg IV 8 consecutive daily doses
Group V: Cohort 1, ApimostinelExperimental Treatment1 Intervention
Apimostinel, 25 mg IV single dose
Group VI: Cohort 3, Placebo 8 consecutive daily dosesPlacebo Group1 Intervention
Placebo IV 8 consecutive daily doses
Group VII: Cohort 1, PlaceboPlacebo Group1 Intervention
Placebo, IV single Dose
Group VIII: Cohort 2, Placebo IV 8 consecutive daily dosesPlacebo Group1 Intervention
Placebo IV 8 consecutive daily doses
Group IX: Cohort 4, Placebo 8 consecutive daily dosesPlacebo Group1 Intervention
Placebo IV 8 consecutive daily doses
Group X: Cohort 5, Placebo IV 8 consecutive daily dosesPlacebo Group1 Intervention
Placebo IV 8 consecutive daily doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
apimostinel
2022
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Gate Neurosciences, IncLead Sponsor
3 Previous Clinical Trials
495 Total Patients Enrolled
3 Trials studying Depression
495 Patients Enrolled for Depression
Ronald M Burch, MD PhDPrincipal InvestigatorGate Neurosciences, Inc
3 Previous Clinical Trials
545 Total Patients Enrolled
2 Trials studying Depression
477 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts underway for this trial?

"Affirmative. According to information hosted on clinicaltrials.gov, this research study is actively seeking participants and was first listed on October 15th 2022. The trial requires 40 individuals from one medical site, with the most recent update being made on October 27th 2022."

Answered by AI

What is the current sample size of this clinical investigation?

"Indeed, per the details posted on clinicaltrials.gov, this study is now recruiting participants. First revealed on October 15th 2022, it was recently updated around 40 days later and requires 40 patients from 1 location."

Answered by AI

Are individuals aged 30+ being considered for involvement in this clinical experiment?

"This clinical trial is limited to those aged between 18 and 55. By contrast, 192 trials are aimed at younger individuals while 968 trials cater to seniors over the age of 65."

Answered by AI

How can we measure the security of administering Apimostinel, 1 mg IV 8 consecutive daily doses to a given population?

"The safety of Cohort 2, Apimostinel is rated a 1 due to the limited data from Phase 1 trials demonstrating efficacy and protecting against potential adverse effects."

Answered by AI

What profile of participant is best suited for this trial?

"To qualify for this clinical trial, candidates must suffer from major depressive disorder (mdd) and be between 18-55 years old. The total number of selected participants is 40 individuals."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
South Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
Multiple Ascending Dose and Electroencephalography Trial of GATE-202 in Healthy Volunteers
2022. "Multiple Ascending Dose and Electroencephalography Trial of GATE-202 in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05597241.
~16 spots leftby Apr 2025
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