NCT05690503Active, not recruitingPhase 2
Glutamatergic Modulation as a Treatment for Depressive Symptoms Among Patients With Post-acute Sequelae of COVID (PASC): A Pilot Trial
Source: ClinicalTrials.gov · Last updated 16 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 30 Dec 2022
- Start date
- 20 Mar 2023
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- New York State Psychiatric Institute
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT05690503
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 12
- From 20 Mar 2023 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- 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
- Any of the following cardiac conditions: clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia within 1 year of signing study consent form.
- Recent history of significant violence (past 2 years) leading to an individual incurring physical harm, police involvement, or resulting in legal action.
Lab values
- 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.
Other
- Pregnant or interested in becoming pregnant during the study period.
- Physiologic dependence on a substance including benzodiazepines, alcohol, or opioids.
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| New York State Psychiatric Institute Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.