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

NCT00768612

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Safety and Tolerability of Vabicaserin in Patients With Sudden Worsening of Schizophrenia
Official Title  ICMJE A Randomized, Double-Blind, Risperidone-Reference, Parallel-Group, Safety, and Tolerability Study of Vabicaserin (SCA-136) in Japanese Subjects With Acute Exacerbation of Schizophrenia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: SCA-136 50mg/day
  • Drug: SCA-136 150 mg/day
  • Drug: SCA-136 300mg/day
  • Drug: Risperidone 4mg/day
Study Arms  ICMJE
  • Experimental: 1
    Lowest dose
    Intervention: Drug: SCA-136 50mg/day
  • Experimental: 2
    Middle dose
    Intervention: Drug: SCA-136 150 mg/day
  • Experimental: 3
    Highest dose
    Intervention: Drug: SCA-136 300mg/day
  • Active Comparator: 4
    Positive Control
    Intervention: Drug: Risperidone 4mg/day
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 28, 2013)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 7, 2008)
60
Estimated Study Completion Date  ICMJE July 2009
Estimated Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00768612
Other Study ID Numbers  ICMJE 3153B1-2208
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date January 2013

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