Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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: Completed Phase 4 study of Schizophrenia, sponsored by Duke University.

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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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

Primary Outcome

A Patient Acceptance Likert Scale (1= Very Acceptable to 7 = Completely Unacceptable, i.e., individual refuses further doses) will be administered to the patient by the Research Nurse on day 14 of treatment.

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
Duke University

1,725 total trials

What the finished NCT01549041 record still lists

NCT01549041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (86% lower).

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 a single indexed study location in 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.

Similar trials for Schizophrenia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01549041's enrollment target sits among peer trials

30 263rd of 315 higher than 49 of 315 other Schizophrenia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Schizophrenia 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

  • NCT00977977 · 30 participants · Phase 2

    Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy

  • NCT01459107 · 30 participants · Phase 2

    Human Upper Extremity Allotransplantation

  • NCT01666080 · 30 participants · NA

    Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)

  • NCT01720836 · 30 participants · Phase 1

    Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer

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

Source: ClinicalTrials.gov NCT01549041, the US trial registry maintained by the National Library of Medicine. NCT01549041 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.