Study Evaluating SCA-136 in Subjects With Acute Exacerbations of Schizophrenia

NCT ID: NCT00265551

Last Updated: 2007-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-01-31

Brief Summary

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The purpose of this study is to determine whether a low dose and a high dose of the study drug SCA-136 are effective and safe in the treatment of schizophrenia requiring hospitalization.

Detailed Description

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Conditions

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Schizophrenia

Keywords

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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SCA-136 (200 mg)

Intervention Type DRUG

SCA-136 (400 mg)

Intervention Type DRUG

olanzapine (15 mg)

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of schizophrenia
* Ability to remain hospitalized for at least first 4 weeks of study
* Needs hospitalization due to worsening of schizophrenia

Exclusion Criteria

* Type 1 or 2 diabetes
* Previous use of clozapine
* Serious medical illness other than schizophrenia
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Little Rock, Arkansas, United States

Site Status

Cerritos, California, United States

Site Status

Costa Mesa, California, United States

Site Status

La Mesa, California, United States

Site Status

Oceanside, California, United States

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Paramount, California, United States

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Pico Rivera, California, United States

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Rosemead, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Torrance, California, United States

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Middletown, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Fort Lauderdale, Florida, United States

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Kissimmee, Florida, United States

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North Miami, Florida, United States

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Hoffman Estates, Illinois, United States

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Indianapolis, Indiana, United States

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Lake Charles, Louisiana, United States

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Baltimore, Maryland, United States

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Rockville, Maryland, United States

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St Louis, Missouri, United States

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Willingboro, New Jersey, United States

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Cedarhurst, New York, United States

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Holliswood, New York, United States

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Chagrin Falls, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Fort Washington, Pennsylvania, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Austin, Texas, United States

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DeSoto, Texas, United States

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Tacoma, Washington, United States

Site Status

Countries

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United States

References

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Shen JH, Zhao Y, Rosenzweig-Lipson S, Popp D, Williams JB, Giller E, Detke MJ, Kane JM. A 6-week randomized, double-blind, placebo-controlled, comparator referenced trial of vabicaserin in acute schizophrenia. J Psychiatr Res. 2014 Jun;53:14-22. doi: 10.1016/j.jpsychires.2014.02.012. Epub 2014 Feb 24.

Reference Type DERIVED
PMID: 24613032 (View on PubMed)

Other Identifiers

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3153A1-202

Identifier Type: -

Identifier Source: org_study_id