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Dopamine Receptor 1 Partial Agonist

Dopamine Receptor Agonist for Schizophrenia

Phase 1 & 2
Waitlist Available
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
Must not have
History of allergy or other contraindication to the proposed pharmacotherapy
History of significant cardiac disease (ex: ischemia, arrhythmia)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to two hours for each fmri session.
Awards & highlights

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 below
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I am between 18 and 45 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic or react badly to certain medications.
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I have a history of serious heart problems.
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I am currently taking olanzapine, clozapine, ziprasidone, or asenapine.
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I have not had major brain injuries, epilepsy, or severe head trauma.
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I have hepatitis B or C and abnormal liver tests.
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I have HIV/AIDS affecting my cognitive abilities.
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I have not had ECT or neurostimulation in the last 6 months and don't plan to start during the study.
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I am currently experiencing a severe episode of depression or mania.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to two hours for each fmri session.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to two hours for each fmri session. for reporting.

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 more

Trial 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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Schizophrenia Spectrum Disorder primarily target dopamine receptors, with a focus on D2 receptor antagonists, which help reduce positive symptoms like hallucinations and delusions by blocking dopamine activity. However, these treatments often do not address cognitive impairments and negative symptoms. Novel treatments, such as the dopamine 1 partial agonist CVL-562, aim to modulate D1 receptors, which are crucial for cognitive functions and working memory. By targeting D1 receptors, these treatments hold promise for improving cognitive deficits and overall functional outcomes in patients, addressing a significant unmet need in schizophrenia care.
High dose antipsychotic polypharmacy and dopamine partial agonists - time to rethink guidelines?The past and future of novel, non-dopamine-2 receptor therapeutics for schizophrenia: A critical and comprehensive review.Dopamine Targeting Drugs for the Treatment of Schizophrenia: Past, Present and Future.

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,820 Previous Clinical Trials
2,692,699 Total Patients Enrolled
Yale UniversityLead Sponsor
1,874 Previous Clinical Trials
2,953,436 Total Patients Enrolled
Columbia UniversityOTHER
1,448 Previous Clinical Trials
2,531,370 Total Patients Enrolled

Media Library

CVL-562 (PF-06412562) 15 mg (Dopamine Receptor 1 Partial Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04457310 — Phase 1 & 2
Schizophrenia Spectrum Disorder Research Study Groups: CVL-562 (PF-06412562) 1 mg, CVL-562 (PF-06412562) 4 mg, CVL-562 (PF-06412562) 25 mg, CVL-562 (PF-06412562) 15 mg, Placebo
Schizophrenia Spectrum Disorder Clinical Trial 2023: CVL-562 (PF-06412562) 15 mg Highlights & Side Effects. Trial Name: NCT04457310 — Phase 1 & 2
CVL-562 (PF-06412562) 15 mg (Dopamine Receptor 1 Partial Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04457310 — Phase 1 & 2
~28 spots leftby Jul 2025