Efficacy and Safety of Asenapine With Placebo and Haloperidol (41023)(P05926)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00156104
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : August 22, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

September 7, 2005
September 12, 2005
August 22, 2017
July 1, 2005
August 18, 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 ]
For treatment of acute schizophrenia
Complete list of historical versions of study NCT00156104 on 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. ]
  • Neurocognition and cognitive functioning [ Time Frame: Baseline and Endpoint ( Day 42) ]
  • CDSS [ Time Frame: Days 21 and 42(Endpoint). ]
  • Suicidal thinking ( ISST modified) [ Time Frame: Days 14 and 42 (Endpoint) ]
  • Quality of life and patient functionality (QLS; Q-LES-Q ;PETIT0; Physical exam; Pregnancy test [ Time Frame: Baseline and Day 42(Endpoint) ]
  • Readiness to discharge [ Time Frame: At weekly intervals during the 6-week trial ]
  • EPS ( AIMS; BARS; SARS) [ Time Frame: At weekly intervals during the 6-week triaL ]
  • Labs; Vital Signs; Weight and girth; ECG [ Time Frame: Days 14; 28 and 42 (Endpoint) ]
  • Safety and Tolerability
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Efficacy and Safety of Asenapine With Placebo and Haloperidol (41023)(P05926)(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.

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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • 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
    Intervention: Other: Placebo arm

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 16, 2006
August 18, 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Canada,   India,   Romania,   Russian Federation,   United States
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Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
August 2017

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