search
Back to results

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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Asenapine
Asenapine
Haloperidol
Placebo arm
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    1

    2

    3

    4

    Arm Description

    Asenapine 5 mg BID

    Asenapine 10 mg BID

    Haloperidol 4m mg BID

    placebo

    Outcomes

    Primary Outcome Measures

    Improvement in schizophrenia (change in total PANSS score) from baseline to endpoint (LOCF/MMRM)

    Secondary Outcome Measures

    Other dimensions of schizophrenia (positive, negative, disorganized thought, hostility/excitement, anxiety/depression, and general psychopathology) CGI-S; CGI-I
    Neurocognition and cognitive functioning
    CDSS
    Suicidal thinking ( ISST modified)
    Quality of life and patient functionality (QLS; Q-LES-Q ;PETIT0; Physical exam; Pregnancy test
    Readiness to discharge
    EPS ( AIMS; BARS; SARS)
    Labs; Vital Signs; Weight and girth; ECG
    Safety and Tolerability

    Full Information

    First Posted
    September 7, 2005
    Last Updated
    February 4, 2022
    Sponsor
    Organon and Co
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00156104
    Brief Title
    Efficacy and Safety of Asenapine With Placebo and Haloperidol (41023)(P05926)(COMPLETED)
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2005 (Actual)
    Primary Completion Date
    August 18, 2006 (Actual)
    Study Completion Date
    September 16, 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    460 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Asenapine 5 mg BID
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Asenapine 10 mg BID
    Arm Title
    3
    Arm Type
    Active Comparator
    Arm Description
    Haloperidol 4m mg BID
    Arm Title
    4
    Arm Type
    Placebo Comparator
    Arm Description
    placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Asenapine
    Intervention Description
    5 mg BID
    Intervention Type
    Drug
    Intervention Name(s)
    Asenapine
    Intervention Description
    10 mg BID
    Intervention Type
    Drug
    Intervention Name(s)
    Haloperidol
    Intervention Description
    4 mg BID
    Intervention Type
    Other
    Intervention Name(s)
    Placebo arm
    Primary Outcome Measure Information:
    Title
    Improvement in schizophrenia (change in total PANSS score) from baseline to endpoint (LOCF/MMRM)
    Time Frame
    Primary outcome measured weekly for 6 weeks
    Secondary Outcome Measure Information:
    Title
    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.
    Title
    Neurocognition and cognitive functioning
    Time Frame
    Baseline and Endpoint ( Day 42)
    Title
    CDSS
    Time Frame
    Days 21 and 42(Endpoint).
    Title
    Suicidal thinking ( ISST modified)
    Time Frame
    Days 14 and 42 (Endpoint)
    Title
    Quality of life and patient functionality (QLS; Q-LES-Q ;PETIT0; Physical exam; Pregnancy test
    Time Frame
    Baseline and Day 42(Endpoint)
    Title
    Readiness to discharge
    Time Frame
    At weekly intervals during the 6-week trial
    Title
    EPS ( AIMS; BARS; SARS)
    Time Frame
    At weekly intervals during the 6-week triaL
    Title
    Labs; Vital Signs; Weight and girth; ECG
    Time Frame
    Days 14; 28 and 42 (Endpoint)
    Title
    Safety and Tolerability

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20520283
    Citation
    Kane JM, Cohen M, Zhao J, Alphs L, Panagides J. Efficacy and safety of asenapine in a placebo- and haloperidol-controlled trial in patients with acute exacerbation of schizophrenia. J Clin Psychopharmacol. 2010 Apr;30(2):106-15. doi: 10.1097/JCP.0b013e3181d35d6b.
    Results Reference
    result
    PubMed Identifier
    25367164
    Citation
    Castle DJ, Slott Jensen JK. Management of depressive symptoms in schizophrenia. Clin Schizophr Relat Psychoses. 2015 Apr;9(1):13-20. doi: 10.3371/CSRP.CAJE.103114.
    Results Reference
    derived
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs