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NCT04457310 · ClinicalTrials.gov registry record · Phase 2
A Translational and Neurocomputational Evaluation of a Dopamine Receptor 1 Partial Agonist for Schizophrenia
A Phase 2 study of Early Course Schizophrenia Spectrum Disorder, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 112
- Enrollment target
- 4
- Study locations
NCT04457310: Completed Phase 2 study of Early Course Schizophrenia Spectrum Disorder, sponsored by Yale University.
NCT04457310 is a Phase 2 study of Early Course Schizophrenia Spectrum Disorder that has completed, run by Yale University. The registered enrollment target is 112 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04457310, a Phase 2 study of Early Course Schizophrenia Spectrum Disorder, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 112 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
Neural activity will be measured by blood oxygen level dependent (BOLD) signal that will be assessed during functional magnetic resonance (fMRI) sessions. During each fMRI session, subjects will participate in a sWM task that involves the ability to keep a spatial location in mind over a short period of time. The sWM task includes four conditions: 1) only sWM; 2) a motor response without sWM; 3) sWM with a distracter presented near the original memory location; and 4) sWM with a distractor prese
Conditions Studied
Interventions
- OTHER Placebo
- DRUG CVL-562 (PF-06412562) 1 mg
- DRUG CVL-562 (PF-06412562) 4 mg
- DRUG CVL-562 (PF-06412562) 15 mg
- DRUG CVL-562 (PF-06412562) 25 mg
Study Locations (4)
New York
- Columbia University - New York
- Stony Brook University - Stony Brook
Connecticut
- Yale University - New Haven
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2021-03-02 |
| Est. Completion | 2024-03-22 |
| Phase | Phase 2 |
What the finished NCT04457310 record still lists
NCT04457310 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower).
The record links to 1 condition, with Early Course Schizophrenia Spectrum Disorder appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT04457310 reports a single indexed study location in New York, Connecticut, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04457310 about?
NCT04457310 is a clinical study titled "A Translational and Neurocomputational Evaluation of a Dopamine Receptor 1 Partial Agonist for Schizophrenia". 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...
What is the current status of trial NCT04457310?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 112 participants. The study started on 2021-03-02. Estimated completion is 2024-03-22.
What conditions does trial NCT04457310 study?
This clinical trial studies the following conditions: Early Course Schizophrenia Spectrum Disorder.
What interventions are being tested in trial NCT04457310?
The interventions under investigation include: Placebo (OTHER), CVL-562 (PF-06412562) 1 mg (DRUG), CVL-562 (PF-06412562) 4 mg (DRUG), CVL-562 (PF-06412562) 15 mg (DRUG), CVL-562 (PF-06412562) 25 mg (DRUG).
Who is sponsoring clinical trial NCT04457310?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04457310 being conducted?
This trial has 4 study locations across Connecticut, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04457310's enrollment target sits among peer trials
112 631st of 2000 higher than 1,369 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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