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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 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. The trial reports 4 study locations across 3 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04457310
The ClinicalTrials.gov registry entry for NCT04457310 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
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 4 study locations spanning 3 distinct geographic areas - top geographies include 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.
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