NCT00768612

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2008

Shorter than P25 for phase_2 schizophrenia

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2008

Completed
24 days until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

8 months

First QC Date

October 7, 2008

Last Update Submit

January 28, 2013

Conditions

Schizophrenia

Keywords

Acute, Schizophrenia, Phase2a, Vabicaserin

Outcome Measures

Primary Outcomes (1)

  • Positive and Negative Syndrome Scale PANSS

    6 week

Secondary Outcomes (1)

  • Calgary Depression Scale for Schizophrenia CDSS

    6 week

Study Arms (4)

1

EXPERIMENTAL

Lowest dose

Drug: SCA-136 50mg/day

2

EXPERIMENTAL

Middle dose

Drug: SCA-136 150 mg/day

3

EXPERIMENTAL

Highest dose

Drug: SCA-136 300mg/day

4

ACTIVE COMPARATOR

Positive Control

Drug: Risperidone 4mg/day

Interventions

SCA-136 50mg/dayDRUG
1
SCA-136 150 mg/dayDRUG
2
SCA-136 300mg/dayDRUG
3
Risperidone 4mg/dayDRUG
4

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Schizophrenia

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2008

First Posted

October 8, 2008

Study Start

November 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

January 29, 2013

Record last verified: 2013-01