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Study Evaluating Safety and Tolerability of Vabicaserin in Patients With Sudden Worsening of Schizophrenia

Primary Purpose

Schizophrenia

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SCA-136 50mg/day
SCA-136 150 mg/day
SCA-136 300mg/day
Risperidone 4mg/day
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Acute, Schizophrenia, Phase2a, Vabicaserin

Eligibility Criteria

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

Inclusion Criteria:

  • Male and female subjects between >=20 and =<65 years of age
  • Current diagnosis and DSM-IV-TR diagnosis of schizophrenia type (295.10, 295.30 and 295.90)
  • Total PANSS score >=70 and =< 120

Exclusion Criteria:

  • Subjects who are hospitalized against their will
  • Current Axis I primary psychiatric diagnosis other than schizophrenia
  • A score of 3 on CDSS question 8 which pertains to suicide

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    1

    2

    3

    4

    Arm Description

    Lowest dose

    Middle dose

    Highest dose

    Positive Control

    Outcomes

    Primary Outcome Measures

    Positive and Negative Syndrome Scale PANSS

    Secondary Outcome Measures

    Calgary Depression Scale for Schizophrenia CDSS

    Full Information

    First Posted
    October 7, 2008
    Last Updated
    January 28, 2013
    Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00768612
    Brief Title
    Study Evaluating Safety and Tolerability of Vabicaserin in Patients With Sudden Worsening of Schizophrenia
    Official Title
    A Randomized, Double-Blind, Risperidone-Reference, Parallel-Group, Safety, and Tolerability Study of Vabicaserin (SCA-136) in Japanese Subjects With Acute Exacerbation of Schizophrenia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2013
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    November 2008 (undefined)
    Primary Completion Date
    July 2009 (Anticipated)
    Study Completion Date
    July 2009 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study will evaluate the clinical safety and tolerability of vabicaserin in Japanese subjects that have a sudden worsening of their symptoms of schizophrenia. The study will also assess the efficacy of vabicaserin and compare it to risperidone.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia
    Keywords
    Acute, Schizophrenia, Phase2a, Vabicaserin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Lowest dose
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Middle dose
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    Highest dose
    Arm Title
    4
    Arm Type
    Active Comparator
    Arm Description
    Positive Control
    Intervention Type
    Drug
    Intervention Name(s)
    SCA-136 50mg/day
    Intervention Type
    Drug
    Intervention Name(s)
    SCA-136 150 mg/day
    Intervention Type
    Drug
    Intervention Name(s)
    SCA-136 300mg/day
    Intervention Type
    Drug
    Intervention Name(s)
    Risperidone 4mg/day
    Primary Outcome Measure Information:
    Title
    Positive and Negative Syndrome Scale PANSS
    Time Frame
    6 week
    Secondary Outcome Measure Information:
    Title
    Calgary Depression Scale for Schizophrenia CDSS
    Time Frame
    6 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male and female subjects between >=20 and =<65 years of age Current diagnosis and DSM-IV-TR diagnosis of schizophrenia type (295.10, 295.30 and 295.90) Total PANSS score >=70 and =< 120 Exclusion Criteria: Subjects who are hospitalized against their will Current Axis I primary psychiatric diagnosis other than schizophrenia A score of 3 on CDSS question 8 which pertains to suicide
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Wyeth is now a wholly owned subsidiary of Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study Evaluating Safety and Tolerability of Vabicaserin in Patients With Sudden Worsening of Schizophrenia

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