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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 is a Early Phase 1 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 68 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG DAR-100A

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2011-04
Est. Completion 2013-11
Phase Early Phase 1

What the Registry Record Tells You About NCT01519557

The ClinicalTrials.gov registry entry for NCT01519557 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01519557 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.