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NCT01549041 · ClinicalTrials.gov registry record · Phase 4

Once-Daily Asenapine for Schizophrenia

A Phase 4 study of Schizophrenia, sponsored by Duke University.

Completed
Registry status
Phase 4
Development phase
30
Enrollment target
1
Study location

NCT01549041 is a Phase 4 study of Schizophrenia that has completed, run by Duke University. The registered enrollment target is 30 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01549041, a Phase 4 study of Schizophrenia, has completed, sponsored by Duke University.

COMPLETED
Registry status
Phase 4
Development phase
30 participants
Enrollment target
1
Study location

Study Summary

The investigators propose to explore: 1. the acceptance by patients of once versus twice daily dosing with asenapine, 2. the acceptance by staff of once versus twice daily dosing with asenapine, and 3. the changes in psychopathology associated with these two dosing strategies, in 30 patients with schizophrenia or schizoaffective disorder. The investigators hypothesize that patient and staff acceptance will be better with once daily dosing and that improvements in psychopathology will be similar across once daily and twice daily dosing

Conditions Studied

Interventions

  • DRUG Asenapine 10 mg daily in the evening
  • DRUG Asenapine 5 mg twice daily

Study Locations (1)

North Carolina

  • Central Regional Hospital - Butner

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2012-04
Est. Completion 2013-11
Phase Phase 4

Sponsor

Duke University

1,725 total trials

What the Registry Record Tells You About NCT01549041

The ClinicalTrials.gov registry entry for NCT01549041 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (86% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Asenapine 10 mg daily in the evening is the first listed.

NCT01549041 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT01549041 about?

NCT01549041 is a clinical study titled "Once-Daily Asenapine for Schizophrenia". The investigators propose to explore: 1. the acceptance by patients of once versus twice daily dosing with asenapine, 2. the acceptance by staff of once versus twice daily dosing with asenapine, and 3. the changes in psychopathology associated with these two dosing strategies, in 30 patients with sc...

What is the current status of trial NCT01549041?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2012-04. Estimated completion is 2013-11.

What conditions does trial NCT01549041 study?

This clinical trial studies the following conditions: Schizophrenia.

What interventions are being tested in trial NCT01549041?

The interventions under investigation include: Asenapine 10 mg daily in the evening (DRUG), Asenapine 5 mg twice daily (DRUG).

Who is sponsoring clinical trial NCT01549041?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01549041 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.