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Efficacy and Safety of Asenapine With Placebo and Haloperidol (41023)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Organon
ClinicalTrials.gov Identifier:
NCT00156104
First received: September 7, 2005
Last updated: August 18, 2008
Last verified: August 2008

September 7, 2005
August 18, 2008
July 2005
September 2006   (final data collection date for primary outcome measure)
Improvement in schizophrenia (change in total PANSS score) from baseline to endpoint (LOCF/MMRM) [ Time Frame: Primary outcome measured weekly for 6 weeks ] [ Designated as safety issue: No ]
For treatment of acute schizophrenia
Complete list of historical versions of study NCT00156104 on ClinicalTrials.gov Archive Site
  • Other dimensions of schizophrenia (positive, negative, disorganized thought, hostility/excitement, anxiety/depression, and general psychopathology) CGI-S; CGI-I [ Time Frame: At weekly intervals throughout the 6-week trial. ] [ Designated as safety issue: Yes ]
  • Neurocognition and cognitive functioning [ Time Frame: Baseline and Endpoint ( Day 42) ] [ Designated as safety issue: Yes ]
  • CDSS [ Time Frame: Days 21 and 42(Endpoint). ] [ Designated as safety issue: Yes ]
  • Suicidal thinking ( ISST modified) [ Time Frame: Days 14 and 42 (Endpoint) ] [ Designated as safety issue: Yes ]
  • Quality of life and patient functionality (QLS; Q-LES-Q ;PETIT0; Physical exam; Pregnancy test [ Time Frame: Baseline and Day 42(Endpoint) ] [ Designated as safety issue: Yes ]
  • Readiness to discharge [ Time Frame: At weekly intervals during the 6-week trial ] [ Designated as safety issue: Yes ]
  • EPS ( AIMS; BARS; SARS) [ Time Frame: At weekly intervals during the 6-week triaL ] [ Designated as safety issue: No ]
  • Labs; Vital Signs; Weight and girth; ECG [ Time Frame: Days 14; 28 and 42 (Endpoint) ] [ Designated as safety issue: Yes ]
  • Safety and Tolerability [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety of Asenapine With Placebo and Haloperidol (41023)(COMPLETED)
A Multicenter, Randomized, Double-Blind, Fixed-Dose, 6-Week Trial of the Efficacy and Safety of Asenapine Compared With Placebo Using Haloperidol Positive Control in Subjects With an Acute Exacerbation of Schizophrenia

Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by Positive symptoms (symptoms that should not be there, inability to think clearly, to distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and relate to others). Other symptoms include reduced ability to recall and learn new information, difficulty with problem solving, or maintaining productive employment. The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other.

Asenapine is an investigational drug that may help to correct the inbalance in dopamine and serotonin. This is a 6-week trial to test the efficacy and safety of asenapine, compared with placebo, using an active comparator agent (haloperidol) in the treatment of patients with an acute exacerbation of schizophrenia. Patients who complete the 6-week trial will have the option of continuing in an additional one year extension trial.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Asenapine
    5 mg BID
  • Drug: Asenapine
    10 mg BID
  • Drug: Haloperidol
    4 mg BID
  • Other: Placebo arm
  • Experimental: 1
    Asenapine 5 mg BID
    Intervention: Drug: Asenapine
  • Experimental: 2
    Asenapine 10 mg BID
    Intervention: Drug: Asenapine
  • Active Comparator: 3
    Haloperidol 4m mg BID
    Intervention: Drug: Haloperidol
  • Placebo Comparator: 4
    placebo
    Intervention: Other: Placebo arm
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
460
October 2006
September 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Currently suffering from an acute exacerbation of schizophrenia. Caregiver required.

Exclusion Criteria:

  • Have an uncontrolled, unstable medical condition. Have any other pyschiatric disorder other than schizophrenia as a primary diagnosis.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00156104
41023, Hera
No
Study Director, NV Organon, part of Schering-Plough Corporation
Organon
Not Provided
Not Provided
Organon
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP