Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01519557 · ClinicalTrials.gov registry record · Early Phase 1
Pharmacologic and Clinical Testing of a D1 Agonist for Cognitive Enhancement in Neuropsychiatric Disorders
A Early Phase 1 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 68
- Enrollment target
NCT01519557: Completed Early Phase 1 study, sponsored by New York State Psychiatric Institute.
NCT01519557 is a Early Phase 1 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 68 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (28% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01519557, a Early Phase 1 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 68 participants
- Enrollment target
Study Summary
The investigators propose to recruit individuals with schizophrenia who are symptomatically stable and already taking medications to participate in this study. The investigators will recruit 90 individuals with schizophrenia and randomize them to low and high doses of DAR-0100A, as well as to placebo. The investigators will have them stay in the hospital for several weeks and receive up to 10 doses of DAR-0100A. The investigators will also test their cognition before and after receiving DAR-0100A to see if DAR-0100A is helpful and perform MRI scans before and after taking the medication to see which areas of the brain are activated when DAR-0100A is administered. These tests will be very important because they will help the investigators determine whether the D1 receptor is a good treatment target for schizophrenia and whether more research and resources should be devoted to finding medications that target this system. Patients with schizophrenia will be free of other medical, psychiatric and neurological disorders including alcohol and substance dependence, and will be able to understand the nature of the study and to provide informed consent.
Primary Outcome
The investigators will measure neural activity during working memory (WM) tasks using blood-oxygen-level-dependent (BOLD)contrast function magnetic resonance imaging (fMRI) and the n-back task and self-ordered object working memory task (SOWMT), prior to (day 0, baseline) and after receiving sub-acute (day 5) treatment with DAR-0100A (15mg or 0.5mg) or placebo.
Interventions
- DRUG Placebo
- DRUG DAR-100A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2011-04 |
| Est. Completion | 2013-11 |
| Phase | Early Phase 1 |
What the finished NCT01519557 record still lists
NCT01519557 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (28% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01519557 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01519557 about?
NCT01519557 is a clinical study titled "Pharmacologic and Clinical Testing of a D1 Agonist for Cognitive Enhancement in Neuropsychiatric Disorders". The investigators propose to recruit individuals with schizophrenia who are symptomatically stable and already taking medications to participate in this study. The investigators will recruit 90 individuals with schizophrenia and randomize them to low and high doses of DAR-0100A, as well as to placeb...
What is the current status of trial NCT01519557?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 68 participants. The study started on 2011-04. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01519557?
The interventions under investigation include: Placebo (DRUG), DAR-100A (DRUG).
Who is sponsoring clinical trial NCT01519557?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01519557's enrollment target sits among peer trials
68 357th of 2000 higher than 1,639 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02044497 · 68 participants · Phase 4
Population Pharmacokinetics and Pharmacogenomics of Oral Oxycodone in Pediatric Surgical Patients
- NCT03779854 · 68 participants · Phase 2
Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant
- NCT03821246 · 68 participants · Phase 2
Neoadjuvant Atezolizumab-Based Combination Therapy in Men With Localized Prostate Cancer Prior to Radical Prostatectomy
- NCT04115514 · 68 participants · Phase 2
Treatment of ARDS With Instilled T3
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia