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Withdrawn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
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Acute, Schizophrenia, Phase2a, Vabicaserin
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
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
NCT ID
NCT00768612
First Posted
October 7, 2008
Last Updated
January 28, 2013
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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Withdrawn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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