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

NCT05690503 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 8336
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Post-acute sequelae of SARS-CoV2 (PASC), colloquially known as "long-COVID," is thought to affect between 10-30% of all COVID-19 survivors. Patients with PASC also report worsening behavioral health symptoms over time that include new-onset depression, anxiety, and even suicidal behavior. The purpose of this randomized, double-blind, controlled trial is to test the efficacy of a glutamate modulator among PASC patients suffering from new-onset or worsening of depressive symptoms.

Conditions

Post-acute Sequelae of COVID-19; Depressive Symptoms; Cognitive Dysfunction

Keywords

Ketamine; PASC; Long Covid

Outcome Measures

Primary Outcomes (1)

• Reduction in depressive symptoms

  from baseline to week 5.

Secondary Outcomes (1)

• Improvement in neurocognitive symptoms of PASC

  from baseline to week 5.

Study Arms (2)

CI-581a+CI-581b

EXPERIMENTAL

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

Drug: CI-581a; Drug: CI-581b

CI-581b+CI-581a

EXPERIMENTAL

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

Drug: CI-581a; Drug: CI-581b

Interventions

CI-581a DRUG

Medication infusion intravenously over 90 minutes.

CI-581a+CI-581b; CI-581b+CI-581a

CI-581b DRUG

Medication infusion intravenously over 90 minutes.

CI-581a+CI-581b; CI-581b+CI-581a

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meeting the case-definition for PASC with depressive symptoms
• Otherwise physically healthy
• No adverse reactions to study medications
• Capacity to consent and comply with study procedures, including sufficient proficiency in English
• Sexually active participants must use an effective form of birth control (condom plus spermicide, diaphragm plus spermicide, or birth control pills) before and throughout their study participation.
• Willingness to provide one or more emergency contacts to the study team

You may not qualify if:

• Meeting the DSM-5 criteria for lifetime history of bipolar disorder, schizophrenia, or any psychotic illness.
• Lifetime history of delirium, dementia, amnesia, or dissociative disorders
• Current suicide risk or a history of suicide attempt within the past year
• Pregnant or interested in becoming pregnant during the study period.
• Any of the following cardiac conditions: clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia within 1 year of signing study consent form.
• Unstable physical disorders which might make participation hazardous such as hypertension (\>160/90), anemia, active hepatitis or other liver disease (transaminase levels \<3 X the upper limit of normal will be considered acceptable), epilepsy, or untreated diabetes. Participants reporting HIV+ status will be asked to provide information about their current treatment, including all medications. Participants who are on the antiretroviral ritonavir (Norvir) will be excluded due to the possibility that ketamine in combination with this medication may increase the risk of drug-induced hepatitis.
• Previous history of a substance use disorder with the study medications, and/or a history of an adverse reaction/experience with prior exposure to the study medications.
• Recent history of significant violence (past 2 years) leading to an individual incurring physical harm, police involvement, or resulting in legal action.
• On psychotropic or other medications whose effect could be disrupted by participation in the study.
• Other personal circumstances and behavior judged to be incompatible with establishment of rapport or safe exposure to the study medications.
• Physiologic dependence on a substance including benzodiazepines, alcohol, or opioids.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Depression; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Saleena Subaiya, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

• Elias Dakwar, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

• Kate O'Malley, MA

  New York State Psychiatric Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: January 19, 2023
• Study Start: March 20, 2023
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

US (1)