SB-773812 Administered In Adults With Schizophrenia

NCT ID: NCT00259870

Last Updated: 2017-03-23

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

338 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-08-31

Brief Summary

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This is a two part study designed to evaluate the safety and efficacy of SB-773812 in the treatment of acute schizophrenia. Subjects with acute schizophrenia will be randomized in an adaptive design study to receive placebo, SB-773812 60mg or olanzapine 15mg for 12 weeks in Part A. An interim analysis will be conducted to assess the efficacy and safety of the SB-773812 60mg dose compared with placebo. Based on these data, up to two further doses of SB-773812 will be added to the randomization for Part B.

Detailed Description

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Conditions

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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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SB-773812

Intervention Type DRUG

Olanzapine

Intervention Type DRUG

Other Intervention Names

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SB-773812

Eligibility Criteria

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Inclusion Criteria

* Meets the diagnostic criteria for schizophrenia as defined in DSM-IV.
* PANSS total score of at least 70 at Screen and Baseline and a minimum score of 4 (moderate) on at least 2 of the following: conceptual disorganization (P2) hallucinatory behaviour (P3) suspiciousness (P6) or unusual thought content (G9) at the Screen and Baseline visits

Exclusion Criteria

* Subjects with a history of epilepsy or other seizure disorder, first episode of schizophrenia or other psychotic disorders (e.g. residual type schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, etc.)
* Bipolar disorder, a history of substance dependence, or a medical or psychiatric disorder that would interfere with the accurate assessment of safety or efficacy are not eligible.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

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Cerritos, California, United States

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Garden Grove, California, United States

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National City, California, United States

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San Diego, California, United States

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Upland, California, United States

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New Haven, Connecticut, United States

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

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North Miami, Florida, United States

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Clementon, New Jersey, United States

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Kenilworth, New Jersey, United States

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Albuquerque, New Mexico, United States

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Orangeburg, New York, United States

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Butner, North Carolina, United States

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Cincinnati, Ohio, United States

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Bellaire, Texas, United States

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San Antonio, Texas, United States

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Falls Church, Virginia, United States

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Liège, , Belgium

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Montignies-sur-Sambre, , Belgium

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San José, , Costa Rica

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Brno, , Czechia

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Lnáře, , Czechia

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Prague, , Czechia

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Ahmedabad, , India

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Bangalore, , India

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Bangalore, , India

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Bangalore, , India

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Hyderabad, , India

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Lucknow, , India

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Ludhiana, , India

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Mangalore, , India

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Pune, , India

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Tirupati, , India

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Lima, Lima Province, Peru

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Leningraskaya Region, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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GSK Investigational Site

Saint Petersburg, , Russia

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GSK Investigational Site

Saint Petersburg, , Russia

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GSK Investigational Site

Saint Petersburg, , Russia

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GSK Investigational Site

Saint Petersburg, , Russia

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GSK Investigational Site

Smolensk, , Russia

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Countries

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United States Belgium Costa Rica Czechia India Peru Russia

Other Identifiers

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NAA104606

Identifier Type: -

Identifier Source: org_study_id

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