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Twelve Month Study Comparing Paliperidone Palmitate and Select Oral Antipsychotics in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital

Primary Purpose

Schizophrenia

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
paliperidone palmitate
risperidone
olanzapine
aripiprazole
haloperidole
quetiapine
perphenazine
paliperidone
Sponsored by
Ortho-McNeil Janssen Scientific Affairs, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Schizophrenia focused on measuring Schizophrenia, Risperidone, Risperdal, Paliperidone palmitate, Aripiprazole, Haloperidol, Olanzapine, Paliperidone, Perphenazine, Quetiapine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Must be able to understand and sign the informed consent form approved by the Institutional Review Board (IRB)
  • Must be an outpatient who, following an acute exacerbation of schizophrenia, has been discharged from an inpatient psychiatric hospital within 60 days of screening
  • Have a current diagnosis of schizophrenia
  • Have available a designated individual who is likely to have knowledge of the subject's health status and who agrees to let the study site personnel know of changes in the patient's circumstances
  • Women must be postmenopausal (for at least 2 years), surgically sterile (hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent, or if sexually active, be practicing a highly effective method of birth control

Exclusion Criteria:

  • Allergies, hypersensitivity (anaphylaxis-type reaction), or intolerance to risperidone or paliperidone
  • Actively abusing intravenous drugs
  • Have a positive urine drug screen test for barbiturates, cocaine, amphetamines, or opiates at screening
  • have an unstable medical illness
  • Women who are pregnant or breast-feeding, or planning to become pregnant
  • Have received injectable antipsychotic treatment within 2 injection cycles prior to screening
  • Received treatment with clozapine within 3 months of screening
  • Attempted suicide within 6 months before screening or are at imminent risk of suicide or violent behavior, as clinically assessed by the investigator at time of screening
  • homeless at time of stuyd consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    001

    002

    003

    004

    005

    006

    007

    008

    Arm Description

    paliperidone palmitate 78 117 156 or 234 mg monthly injection for 12 months

    olanzapine flexible dosing as prescribed by the study doctor for 12 months

    paliperidone flexible dosing as prescribed by the study doctor for 12 months

    aripiprazole flexible dosing as prescribed by the study doctor for 12 months

    haloperidole flexible dosing as prescribed by the study doctor for 12 months

    perphenazine flexible dosing as prescribed by the study doctor for 12 months

    quetiapine flexible dosing as prescribed by the study doctor for 12 months

    risperidone flexible dosing as prescribed by the study doctor for 12 months

    Outcomes

    Primary Outcome Measures

    Time to treatment failure defined as psychiatric hospitalization, suicide, discontinuation of treatment due to inadequate efficacy or safety/tolerability, treatment supplementation due to inadequate efficacy, or increase in psychiatric services

    Secondary Outcome Measures

    Change in Clinical Global Impression-Severity score
    Change in Global Assessment of Functionality score
    Change in Medication Satisfaction Questionnaire score
    Proportion of subjects with at least one psychiatric hospitalization

    Full Information

    First Posted
    August 30, 2010
    Last Updated
    July 4, 2013
    Sponsor
    Ortho-McNeil Janssen Scientific Affairs, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01193166
    Brief Title
    Twelve Month Study Comparing Paliperidone Palmitate and Select Oral Antipsychotics in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital
    Official Title
    A Twelve-Month, Prospective, Randomized, Active-Controlled, Open-Label, Flexible-Dose Study of Paliperidone Palmitate Compared With Oral Antipsychotic Treatment in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2013
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    This study was stopped due to an internal reconsideration of priorities of the product portfolio.
    Study Start Date
    August 2010 (undefined)
    Primary Completion Date
    September 2012 (Anticipated)
    Study Completion Date
    September 2012 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ortho-McNeil Janssen Scientific Affairs, LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study will assess the use of paliperidone palmitate compared with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 12 months, in patients diagnosed with schizophrenia who were recently released from an inpatient psychiatric hospital.
    Detailed Description
    The primary objective of this study will be to compare paliperidone palmitate treatment with the randomly assigned oral antipsychotic treatment in delaying time to treatment failure over 12 months in subjects diagnosed with schizophrenia who were recently discharged from an inpatient psychiatric hospital. Patients will receive either paliperidone palmitate 78, 117, 156, or 234 mg monthly by injection for twelve months OR oral aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone at doses selected by the study doctor.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia
    Keywords
    Schizophrenia, Risperidone, Risperdal, Paliperidone palmitate, Aripiprazole, Haloperidol, Olanzapine, Paliperidone, Perphenazine, Quetiapine

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    001
    Arm Type
    Experimental
    Arm Description
    paliperidone palmitate 78 117 156 or 234 mg monthly injection for 12 months
    Arm Title
    002
    Arm Type
    Active Comparator
    Arm Description
    olanzapine flexible dosing as prescribed by the study doctor for 12 months
    Arm Title
    003
    Arm Type
    Active Comparator
    Arm Description
    paliperidone flexible dosing as prescribed by the study doctor for 12 months
    Arm Title
    004
    Arm Type
    Active Comparator
    Arm Description
    aripiprazole flexible dosing as prescribed by the study doctor for 12 months
    Arm Title
    005
    Arm Type
    Active Comparator
    Arm Description
    haloperidole flexible dosing as prescribed by the study doctor for 12 months
    Arm Title
    006
    Arm Type
    Active Comparator
    Arm Description
    perphenazine flexible dosing as prescribed by the study doctor for 12 months
    Arm Title
    007
    Arm Type
    Active Comparator
    Arm Description
    quetiapine flexible dosing as prescribed by the study doctor for 12 months
    Arm Title
    008
    Arm Type
    Active Comparator
    Arm Description
    risperidone flexible dosing as prescribed by the study doctor for 12 months
    Intervention Type
    Drug
    Intervention Name(s)
    paliperidone palmitate
    Intervention Description
    78, 117, 156, or 234 mg monthly injection for 12 months
    Intervention Type
    Drug
    Intervention Name(s)
    risperidone
    Intervention Description
    flexible dosing as prescribed by the study doctor for 12 months
    Intervention Type
    Drug
    Intervention Name(s)
    olanzapine
    Intervention Description
    flexible dosing as prescribed by the study doctor for 12 months
    Intervention Type
    Drug
    Intervention Name(s)
    aripiprazole
    Intervention Description
    flexible dosing as prescribed by the study doctor for 12 months
    Intervention Type
    Drug
    Intervention Name(s)
    haloperidole
    Intervention Description
    flexible dosing as prescribed by the study doctor for 12 months
    Intervention Type
    Drug
    Intervention Name(s)
    quetiapine
    Intervention Description
    flexible dosing as prescribed by the study doctor for 12 months
    Intervention Type
    Drug
    Intervention Name(s)
    perphenazine
    Intervention Description
    flexible dosing as prescribed by the study doctor for 12 months
    Intervention Type
    Drug
    Intervention Name(s)
    paliperidone
    Intervention Description
    flexible dosing as prescribed by the study doctor for 12 months
    Primary Outcome Measure Information:
    Title
    Time to treatment failure defined as psychiatric hospitalization, suicide, discontinuation of treatment due to inadequate efficacy or safety/tolerability, treatment supplementation due to inadequate efficacy, or increase in psychiatric services
    Time Frame
    Up to 12 months
    Secondary Outcome Measure Information:
    Title
    Change in Clinical Global Impression-Severity score
    Time Frame
    Up to 12 months
    Title
    Change in Global Assessment of Functionality score
    Time Frame
    Up to 12 months
    Title
    Change in Medication Satisfaction Questionnaire score
    Time Frame
    Up to 12 months
    Title
    Proportion of subjects with at least one psychiatric hospitalization
    Time Frame
    Up to 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Must be able to understand and sign the informed consent form approved by the Institutional Review Board (IRB) Must be an outpatient who, following an acute exacerbation of schizophrenia, has been discharged from an inpatient psychiatric hospital within 60 days of screening Have a current diagnosis of schizophrenia Have available a designated individual who is likely to have knowledge of the subject's health status and who agrees to let the study site personnel know of changes in the patient's circumstances Women must be postmenopausal (for at least 2 years), surgically sterile (hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent, or if sexually active, be practicing a highly effective method of birth control Exclusion Criteria: Allergies, hypersensitivity (anaphylaxis-type reaction), or intolerance to risperidone or paliperidone Actively abusing intravenous drugs Have a positive urine drug screen test for barbiturates, cocaine, amphetamines, or opiates at screening have an unstable medical illness Women who are pregnant or breast-feeding, or planning to become pregnant Have received injectable antipsychotic treatment within 2 injection cycles prior to screening Received treatment with clozapine within 3 months of screening Attempted suicide within 6 months before screening or are at imminent risk of suicide or violent behavior, as clinically assessed by the investigator at time of screening homeless at time of stuyd consent
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial
    Organizational Affiliation
    Ortho-McNeil Janssen Scientific Affairs, LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Twelve Month Study Comparing Paliperidone Palmitate and Select Oral Antipsychotics in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital

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