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

Last updated on October 5, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
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 =

- Current diagnosis and DSM-IV-TR diagnosis of schizophrenia type (295.10, 295.30 and
295.90)

- Total PANSS score >=70 and =

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

NCT00768612
Pfizer
Withdrawn
Study Evaluating Safety and Tolerability of Vabicaserin in Patients With Sudden Worsening of Schizophrenia

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Study Evaluating Safety and Tolerability of Vabicaserin in Patients With Sudden Worsening of Schizophrenia
A Randomized, Double-Blind, Risperidone-Reference, Parallel-Group, Safety, and Tolerability Study of Vabicaserin (SCA-136) in Japanese Subjects With Acute Exacerbation of Schizophrenia
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Schizophrenia
  • Drug: SCA-136 50mg/day
  • Drug: SCA-136 150 mg/day
  • Drug: SCA-136 300mg/day
  • Drug: Risperidone 4mg/day
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
July 2009
July 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00768612
3153B1-2208
Yes
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
January 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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