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Glutamate Modulator
Glutamatergic Modulation for Post-COVID Depression
Phase 2
Waitlist Available
Led By Elias Dakwar, 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 up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a medication that adjusts a brain chemical called glutamate to help people with long-term COVID-19 effects who are experiencing depression. Many studies have recently been conducted to assess the antidepressant efficacy of glutamate modification in mood disorders. The goal is to see if this treatment can improve their mood and mental clarity. The study involves giving the medication through infusions over several weeks.
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.
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.
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 ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Find a Location
Who is running the clinical trial?
New York State Psychiatric InstituteLead Sponsor
478 Previous Clinical Trials
153,961 Total Patients Enrolled
Elias Dakwar, MDPrincipal InvestigatorNew York State Psychiatric Institute
9 Previous Clinical Trials
525 Total Patients Enrolled
Kate O'Malley, MAStudy DirectorNew York State Psychiatric Institute
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with bipolar disorder, schizophrenia, or any psychotic illness according to the DSM-5 criteria.You have been involved in a serious violent incident in the past two years that caused physical harm or led to police or legal involvement.You have uncontrolled high blood pressure, anemia, liver disease, epilepsy, or untreated diabetes. If you have HIV, you may be asked about your current treatment. If you are taking a specific HIV medication called ritonavir (Norvir), you will not be able to participate.You have recently tried to hurt yourself or are currently feeling like you might.You have had a history of severe memory or thinking problems.You are physically dependent on substances like benzodiazepines, alcohol, or opioids.You have a heart condition such as a very thick heart muscle, chest pain, or a significant heart rhythm problem within the past year.You are taking medications that might be affected by being in the study.You have not had any bad reactions to the study drugs before.You have had problems with drug or alcohol abuse, or have had a bad reaction to the study medications before.You have been diagnosed with PASC and are experiencing symptoms of depression.
Research Study Groups:
This trial has the following groups:- Group 1: CI-581a+CI-581b
- Group 2: CI-581b+CI-581a
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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