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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00768612
First received: October 7, 2008
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone
U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Positive and Negative Syndrome Scale PANSS [ Time Frame: 6 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Calgary Depression Scale for Schizophrenia CDSS [ Time Frame: 6 week ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: November 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00768612

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

No publications provided

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00768612     History of Changes
Other Study ID Numbers: 3153B1-2208
Study First Received: October 7, 2008
Last Updated: January 28, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 22, 2013