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Glutamate Modulator

Glutamatergic Modulation for Post-COVID Depression

Phase 2

Recruiting

Led By Saleena Subaiya, MD

Research Sponsored by New York State Psychiatric Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to week 5.

Awards & highlights

Study Summary

This trial tests if a drug can help reduce depression in those who have had long-term effects of COVID-19. Up to 30% of survivors experience worsening depression, anxiety, & suicidal ideation over time.

Who is the study for?

This trial is for English-speaking adults who've had COVID-19 and are now experiencing new or worsening depression, but are otherwise physically healthy. They must use effective birth control if sexually active, provide emergency contacts, have no severe reactions to the study drugs, and meet PASC criteria with depressive symptoms.Check my eligibility

What is being tested?

The trial is testing two glutamate modulators (CI-581a and CI-581b) to see if they can help with depression in patients with long-COVID. It's a randomized, double-blind study which means participants won't know which treatment they're getting and neither will the researchers.See study design

What are the potential side effects?

While specific side effects aren't listed here, glutamate modulators like those being tested may cause changes in mood or behavior, dizziness or confusion. Participants should report any unusual feelings or symptoms during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to week 5.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to week 5.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 5. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Reduction in depressive symptoms

Secondary outcome measures

Improvement in neurocognitive symptoms of PASC

Trial Design

2Treatment groups

Experimental Treatment

Group I: CI-581b+CI-581aExperimental Treatment2 Interventions

Administration of CI-581b at 0.025mg/kg during week 1. Administration of CI-581a at 0.8mg/kg during week 3.

Group II: CI-581a+CI-581bExperimental Treatment2 Interventions

Administration of CI-581a at 0.8mg/kg during week 1. Administration of CI-581b at 0.025mg/kg during week 3.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CI-581a

2013

Completed Phase 3

~80

CI-581b

2013

Completed Phase 3

~70

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor

475 Previous Clinical Trials

153,895 Total Patients Enrolled

81 Trials studying Depression

10,710 Patients Enrolled for Depression

Saleena Subaiya, MDPrincipal InvestigatorNew York State Psychiatric Institute

Kate O'Malley, MAStudy DirectorNew York State Psychiatric Institute

Media Library

CI-581a (Glutamate Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05690503 — Phase 2

Depression Research Study Groups: CI-581a+CI-581b, CI-581b+CI-581a

Depression Clinical Trial 2023: CI-581a Highlights & Side Effects. Trial Name: NCT05690503 — Phase 2

CI-581a (Glutamate Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05690503 — Phase 2

Frequently Asked Questions

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

Does this clinical trial include those over the age of thirty-five?

"Patients wishing to partake in this research must be between 18 and 65 years of age. There are 199 studies specifically targeting those under the legal age of consent, while 1386 focus on seniors above 65."

Answered by AI

What impacts could CI-581a+CI-581b have on the health of participants?

"An analysis by Power yielded a risk rating of 2 for CI-581a+CI-581b, due to the lack of clinical data regarding efficacy but also considering the limited safety information available from Phase 2 trials."

Answered by AI

Are there any availabilities for people to join this clinical trial?

"Affirmative. Data hosted on clinicaltrials.gov affirms that this medical trial, initially posted in March of 2023, is currently enrolling participants. 12 individuals are needed at a single research site."

Answered by AI

How many participants are participating in the current clinical trial?

"Affirmative. The clinical trials website reflects that this research is actively searching for participants and was initially published on March 20th, 2023 before being amended on the 30th of the same month. 12 patients are sought to be enrolled in one trial site."

Answered by AI

What are the qualifying criteria for participation in this trial?

"This research project is actively seeking 12 patients aged 18-65 who are suffering from cognitive impairment. In addition to these basic requirements, potential participants must meet the case definition for PASC with depressive symptoms and be in generally good physical health without any adverse reactions to study medications. Additionally, applicants should have a capacity to provide informed consent and comprehend English instructions; sexually active individuals must use birth control throughout their participation; willing to give emergency contacts information if necessary."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Glutamatergic Modulation as a Treatment for Depressive Symptoms Among Patients With Post-acute Sequelae of COVID (PASC): A Pilot Trial

Elias Dakwar 2023. "Glutamatergic Modulation as a Treatment for Depressive Symptoms Among Patients With Post-acute Sequelae of COVID (PASC): A Pilot Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05690503.