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NCT01979679 · ClinicalTrials.gov registry record · Phase 3
A D2 Receptor Occupancy and fMRI Study in Schizophrenic Subjects Treated With Lurasidone
A Phase 3 study, sponsored by University of California, Irvine.
- Completed
- Registry status
- Phase 3
- Development phase
- 28
- Enrollment target
NCT01979679: Completed Phase 3 study, sponsored by University of California, Irvine.
NCT01979679 is a Phase 3 study that has completed, run by University of California, Irvine. The registered enrollment target is 28 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01979679, a Phase 3 study, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 28 participants
- Enrollment target
Study Summary
The purpose of this research study is to measure how many of the dopamine receptors lurasidone occupies throughout the brain of patients with schizophrenia or schizoaffective disorder and over what time period the occupancy occurs. This is research because lurasidone is an investigational medication that has not yet been approved by the Food and Drug Administration (FDA). Dopamine receptors have key roles in many processes, including the control of motivation, learning, and fine motor movement. The degree of occupancy and the transience of occupancy D2 receptor occupancy for optimal clinical response and to prevent relapses is a controversial area that this study will address. In this study Positron Emission Tomography (PET) scanning will be performed with D2/D3 ligand 18F-fallypride (a radioactive, injectable substance) to help the researchers measure the use of these receptors. Researchers hope that quantifying the amount of receptors being occupied by the medication will help them to determine the best dose of study medication in terms of improvement and least side effects related to body size and gender as well as in preventing relapse that may be related to hypersensitivity. Magnetic Resonance Imaging (fMRI) will also be performed. MRI is a scanning method which makes pictures of parts of the brain using a large magnetic field. This study will use a particular kind of MRI called fMRI, or functional MRI. fMRI takes pictures of the brain while the person is thinking or doing a simple task. fMRI will allow the researchers to investigate patients regional brain activation during cognitive (mental) and emotional tasks.
Primary Outcome
To determine whether additional D2 receptor occupancy can be accomplished with doses of 160 mg of lurasidone per day.
Interventions
- DRUG Lurasidone 80 mg
- DRUG Lurasidone 120 mg
- DRUG Lurasidone 160 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2008-12 |
| Phase | Phase 3 |
What the finished NCT01979679 record still lists
NCT01979679 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Lurasidone 80 mg is the first listed.
NCT01979679 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01979679 about?
NCT01979679 is a clinical study titled "A D2 Receptor Occupancy and fMRI Study in Schizophrenic Subjects Treated With Lurasidone". The purpose of this research study is to measure how many of the dopamine receptors lurasidone occupies throughout the brain of patients with schizophrenia or schizoaffective disorder and over what time period the occupancy occurs. This is research because lurasidone is an investigational medication...
What is the current status of trial NCT01979679?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 28 participants. The study started on 2008-12.
What interventions are being tested in trial NCT01979679?
The interventions under investigation include: Lurasidone 80 mg (DRUG), Lurasidone 120 mg (DRUG), Lurasidone 160 mg (DRUG).
Who is sponsoring clinical trial NCT01979679?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01979679's enrollment target sits among peer trials
28 1935th of 2000 higher than 65 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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