CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 112 enrolled
Drug / intervention
CVL-562 (PF-06412562) 1 mg +4 moredrug
Likely dose
CVL-562 (PF-06412562) 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04457310
NCT04457310Phase 2Completed

A Translational and Neurocomputational Evaluation of a Dopamine Receptor 1 Partial Agonist for Schizophrenia

Yale University·interventional·Posted Jul 7, 2020·Updated Oct 15, 2025

In Brief

A Phase 2 clinical trial evaluating CVL-562 (PF-06412562) 1 mg, CVL-562 (PF-06412562) 4 mg, and 3 other interventions for Early Course Schizophrenia Spectrum Disorder. Completed, enrolled 112 participants across 4 sites.

Detailed Summary

This study will test whether CVL-562 (PF-06412562), a dopamine 1 partial agonist novel compound, affects working memory neural circuits in patients with early episode schizophrenia. The overall aim is to establish neuroimaging biomarkers of the Dopamine Receptor 1/Dopamine Receptor 5 Family (D1R/D5R) target engagement to accelerate development of D1R/D5R agonists in humans to treat cognitive impairments that underlie functional disability in schizophrenia, a key unaddressed clinical and public health concern.

Study Details

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJul 7, 2020
Enrollment StartMar 2, 2021
Primary CompletionMar 22, 2024
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 6.0 years ago

Interventions

CVL-562 (PF-06412562) 1 mgdrug

Each subject will complete 5 test visits each involving the administration of CVL-562 (PF-06412562) (at different doses) or placebo. Each test visit will be separated by at least 48 hours (six half-lives of CVL-562 (PF-06412562)).

CVL-562 (PF-06412562) 4 mgdrug

Each subject will complete 5 test visits each involving the administration of CVL-562 (PF-06412562) (at different doses) or placebo. Each test visit will be separated by at least 48 hours (six half-lives of CVL-562 (PF-06412562)).

CVL-562 (PF-06412562) 15 mgdrug

Each subject will complete 5 test visits each involving the administration of CVL-562 (PF-06412562) (at different doses) or placebo. Each test visit will be separated by at least 48 hours (six half-lives of CVL-562 (PF-06412562)).

CVL-562 (PF-06412562) 25 mgdrug

Each subject will complete 5 test visits each involving the administration of CVL-562 (PF-06412562) (at different doses) or placebo. Each test visit will be separated by at least 48 hours (six half-lives of CVL-562 (PF-06412562)).

Placeboother

Each subject will complete 5 test visits each involving the administration of CVL-562 (PF-06412562) (at different doses) or placebo. Each test visit will be separated by at least 48 hours (six half-lives of CVL-562 (PF-06412562)).