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Study Evaluating Vabicaserin in Subjects With Schizophrenia

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Little Rock, Arkansas, 72201 United States
Contact
1-800-718-1021
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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Study Evaluating Vabicaserin in Subjects With Schizophrenia
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • 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
  • Experimental: 1
    Intervention: Drug: vabicaserin
  • Active Comparator: 2
    4mg/day
    Intervention: Drug: risperidone
  • Placebo Comparator: 3
    matching placebo
    Intervention: Other: placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
199
June 2008
June 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00563706
3153A1-2203
B1911032
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2014

ICMJE     Data element required by the

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

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1-800-718-1021

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