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Dopamine Receptor 1 Partial Agonist
Dopamine Receptor Agonist for Schizophrenia
Phase 1 & 2
Recruiting
Led By John Krystal, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Between the ages of 18 (including 18 years of age) and 45 (up to 45 years and 11 months) at the time of baseline study visit
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to two hours for each fmri session.
Awards & highlights
Study Summary
This trial will test whether CVL-562, a dopamine 1 partial agonist, affects working memory in patients with early episode schizophrenia. The goal is to establish neuroimaging biomarkers of the Dopamine Receptor 1/Dopamine Receptor 5 Family target engagement to accelerate development of D1R/D5R agonists in humans to treat cognitive impairments in schizophrenia.
Who is the study for?
This trial is for individuals aged 18-45 with early episode schizophrenia, schizoaffective disorder, or schizophreniform disorder. They must be fluent in English, not pregnant or planning to become so during the study, and on stable psychiatric medication for at least two months. Participants should have no significant medical conditions that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing CVL-562 (PF-06412562), a dopamine receptor partial agonist at different doses (1 mg, 4 mg, 15 mg, and 25 mg) against a placebo. It aims to see if this drug can improve working memory by engaging certain brain receptors using neuroimaging as a measure of effectiveness.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical reactions associated with central nervous system drugs such as headaches, dizziness, nausea, restlessness or other changes in mood or behavior.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 45 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to two hours for each fmri session.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to two hours for each fmri session.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neural activity across brain regions during a spatial working memory (sWM) task.
Secondary outcome measures
Association between neural activity and task performance
Functional connectivity across brain regions with the fronto-parietal network during sWM task
Performance during spatial working memory (sWM) task
+3 moreTrial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: CVL-562 (PF-06412562) 4 mgExperimental Treatment1 Intervention
Each subject will complete 5 test visits each involving the administration of CVL-562 (PF-06412562) (at different doses) or placebo. Subjects will be randomized to the order of doses of CVL-562 (PF-06412562) (1 mg, 4 mg, 15 mg, or 25 mg) or placebo for the next 5 visits. The randomization will assign 75% of patients to the highest dose on the last visit and 25% would receive the highest dose on one of the other four visits. Only the highest dose (25 mg) will be subject to this pseudo-randomization strategy; all other doses will be randomly distributed.
Group II: CVL-562 (PF-06412562) 25 mgExperimental Treatment1 Intervention
Each subject will complete 5 test visits each involving the administration of CVL-562 (PF-06412562) (at different doses) or placebo. Subjects will be randomized to the order of doses of CVL-562 (PF-06412562) (1 mg, 4 mg, 15 mg, or 25 mg) or placebo for the next 5 visits. The randomization will assign 75% of patients to the highest dose on the last visit and 25% would receive the highest dose on one of the other four visits. Only the highest dose (25 mg) will be subject to this pseudo-randomization strategy; all other doses will be randomly distributed.
Group III: CVL-562 (PF-06412562) 15 mgExperimental Treatment1 Intervention
Each subject will complete 5 test visits each involving the administration of CVL-562 (PF-06412562) (at different doses) or placebo. Subjects will be randomized to the order of doses of CVL-562 (PF-06412562) (1 mg, 4 mg, 15 mg, or 25 mg) or placebo for the next 5 visits. The randomization will assign 75% of patients to the highest dose on the last visit and 25% would receive the highest dose on one of the other four visits. Only the highest dose (25 mg) will be subject to this pseudo-randomization strategy; all other doses will be randomly distributed.
Group IV: CVL-562 (PF-06412562) 1 mgExperimental Treatment1 Intervention
Each subject will complete 5 test visits each involving the administration of CVL-562 (PF-06412562) (at different doses) or placebo. Subjects will be randomized to the order of doses of CVL-562 (PF-06412562) (1 mg, 4 mg, 15 mg, or 25 mg) or placebo for the next 5 visits. The randomization will assign 75% of patients to the highest dose on the last visit and 25% would receive the highest dose on one of the other four visits. Only the highest dose (25 mg) will be subject to this pseudo-randomization strategy; all other doses will be randomly distributed.
Group V: PlaceboPlacebo Group1 Intervention
Each subject will complete 5 test visits each involving the administration of CVL-562 (PF-06412562) (at different doses) or placebo. Subjects will be randomized to the order of doses of CVL-562 (PF-06412562) (1 mg, 4 mg, 15 mg, or 25 mg) or placebo for the next 5 visits. The randomization will assign 75% of patients to the highest dose on the last visit and 25% would receive the highest dose on one of the other four visits. Only the highest dose (25 mg) will be subject to this pseudo-randomization strategy; all other doses will be randomly distributed.
Find a Location
Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,647 Total Patients Enrolled
Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,321 Total Patients Enrolled
Columbia UniversityOTHER
1,433 Previous Clinical Trials
2,447,139 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic or react badly to certain medications.I have a history of serious heart problems.I am between 18 and 45 years old.I am currently taking olanzapine, clozapine, ziprasidone, or asenapine.You have a history of ADHD (Attention-Deficit/Hyperactivity Disorder) before developing psychosis or other mental health conditions that can affect your thinking abilities.I have not had major brain injuries, epilepsy, or severe head trauma.I can follow simple instructions and move as needed for a memory task.I haven't used certain sleep or seizure medications daily for the last 10 days.My current medications don't mix with the study's treatment, according to my psychiatrist.I haven't taken any strong medication or grapefruit juice in the last 10 days.My psychosis started less than 10 years ago.You have color blindness, eyes that do not align properly (strabismus), or other vision problems that cannot be corrected. If you wear glasses, you will be asked to use special glasses that can be safely used during an MRI.I understand the study and have signed the consent form.My mental health medication has been stable for 3 weeks, and I won't change it during the study.I have been mentally stable for the last two months without hospital visits or harmful thoughts.I have hepatitis B or C and abnormal liver tests.I have HIV/AIDS affecting my cognitive abilities.I have a condition like severe claustrophobia or obesity that makes long MRIs hard for me.My mental health medication dose has been stable for over 3 weeks.I do not have any metal implants that are unsafe for MRI, except possibly a copper IUD.I have not had ECT or neurostimulation in the last 6 months and don't plan to start during the study.I am currently experiencing a severe episode of depression or mania.
Research Study Groups:
This trial has the following groups:- Group 1: CVL-562 (PF-06412562) 1 mg
- Group 2: CVL-562 (PF-06412562) 4 mg
- Group 3: CVL-562 (PF-06412562) 25 mg
- Group 4: CVL-562 (PF-06412562) 15 mg
- Group 5: Placebo
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is the research cohort being expanded?
"Affirmative. Perusal of clinicaltrials.gov reveals that this research is actively recruiting subjects; it was initially posted on March 2nd 2021 and most recently updated August 8th 2022. 120 individuals need to be enrolled from 4 distinct sites."
Answered by AI
Am I eligible to join in on this investigation?
"This clinical trial seeks to enrol 120 patients suffering from schizophrenia who range in age between 18 and 45. In order for a patient to be eligible, they must meet the following requirements: provide an informed consent (as established through an interview), sign a voluntary informed consent prior to any study-specific procedures being performed, have been diagnosed with psychosis within 10 years of the start of this study, accept treatment constraints presented by the research team, have a PRA score that correlates with their IQ on other tests such as WRAT which measures intelligence but is briefer than other exams so it eases burden on participants during initial visit, demonstrate fluency in"
Answered by AI
Are there currently any opportunities for enrolment in this research endeavor?
"Affirmative, clinicaltrials.gov indicates that this research is currently recruiting participants with the first post date being March 2nd 2021 and most recent update on August 8th 2022. The project requires 120 volunteers at 4 different medical facilities."
Answered by AI
Does this research trial accept participants aged 65 and above?
"The age range for this clinical trial is 18 to 45 years of age, as specified in the requirements necessary for inclusion."
Answered by AI
What is the geographic extent of this clinical trial?
"Four different medical facilities are enrolling patients in this clinical trial, including Columbia University (New york City), Yale University (New Haven), and the University of Pennsylvania (Philadelphia). Additionally, there are other potential sites."
Answered by AI
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