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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00768612
Recruitment Status : Withdrawn
First Posted : October 8, 2008
Last Update Posted : January 29, 2013
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: SCA-136 50mg/day Drug: SCA-136 150 mg/day Drug: SCA-136 300mg/day Drug: Risperidone 4mg/day Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : November 2008
Estimated Primary Completion Date : July 2009
Estimated Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone

Arm Intervention/treatment
Experimental: 1
Lowest dose
Drug: SCA-136 50mg/day
Experimental: 2
Middle dose
Drug: SCA-136 150 mg/day
Experimental: 3
Highest dose
Drug: SCA-136 300mg/day
Active Comparator: 4
Positive Control
Drug: Risperidone 4mg/day

Primary Outcome Measures :
  1. Positive and Negative Syndrome Scale PANSS [ Time Frame: 6 week ]

Secondary Outcome Measures :
  1. Calgary Depression Scale for Schizophrenia CDSS [ Time Frame: 6 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00768612

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer Identifier: NCT00768612     History of Changes
Other Study ID Numbers: 3153B1-2208
First Posted: October 8, 2008    Key Record Dates
Last Update Posted: January 29, 2013
Last Verified: January 2013

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Acute, Schizophrenia, Phase2a, Vabicaserin

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents