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Study Evaluating Vabicaserin in Subjects With Schizophrenia

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NCT00563706

Last updated on April 3, 2020
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Little Rock, Arkansas, 72201 United States
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Generally healthy, men and women, aged 18 to 65.

- Hospitalization because of an acute exacerbation of schizophrenia with a diagnosis of
schizophrenia established greater than 1 year.

- Ability to remain hospitalized for the duration of the screening period and for 4
weeks of double-blind treatment.

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

- Current Axis I primary psychiatric diagnosis other than schizophrenia (DSM-IV-TR
criteria).

- Current diagnosis or history of substance abuse or dependence (DSM-IV-TR criteria),
including alcohol (except for nicotine), within 3 months before baseline (day -1).

- Subjects taking high or chronic doses of benzodiazepine at the screening evaluation
who, in the investigator's judgment, would be likely to have severe withdrawal
symptoms upon discontinuation.

NCT00563706
Pfizer
Completed
Study Evaluating Vabicaserin in Subjects With Schizophrenia

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Descriptive Information
Brief Title  ICMJE Study Evaluating Vabicaserin in Subjects With Schizophrenia
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Risperidone-Referenced, Parallel-Group, Adaptive-Design Study of the Efficacy, Safety, and Tolerability of Vabicaserin (SCA-136) in Subjects With Acute Exacerbations of Schizophrenia
Brief Summary The primary purpose of this protocol is to establish the efficacy, safety, and tolerability of vabicaserin (SCA-136) using a once a day capsule in subjects with acute exacerbations of schizophrenia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: vabicaserin
    This study will utilize a randomized, double-blind, placebo-controlled, comparator-referenced, multicenter, parallel-group adaptive design with placebo, risperidone (4 mg/day), and up to 7 treatment arms of vabicaserin (50, 100, 150, 200, 300, 400 and 600 mg/day) over the course of the study
  • Drug: risperidone
  • Other: placebo
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: vabicaserin
  • Active Comparator: 2
    4mg/day
    Intervention: Drug: risperidone
  • Placebo Comparator: 3
    matching placebo
    Intervention: Other: placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: June 7, 2012) 		199
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Generally healthy, men and women, aged 18 to 65.
  • Hospitalization because of an acute exacerbation of schizophrenia with a diagnosis of schizophrenia established greater than 1 year.
  • Ability to remain hospitalized for the duration of the screening period and for 4 weeks of double-blind treatment.

Exclusion Criteria:

  • Current Axis I primary psychiatric diagnosis other than schizophrenia (DSM-IV-TR criteria).
  • Current diagnosis or history of substance abuse or dependence (DSM-IV-TR criteria), including alcohol (except for nicotine), within 3 months before baseline (day -1).
  • Subjects taking high or chronic doses of benzodiazepine at the screening evaluation who, in the investigator's judgment, would be likely to have severe withdrawal symptoms upon discontinuation.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00563706
Other Study ID Numbers  ICMJE 3153A1-2203
B1911032
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2014

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 the study website. Please see the references below:

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