SB-773812 Administered In Adults With Schizophrenia

March 21, 2017 updated by: GlaxoSmithKline

A Multi Centre, Double-Blind, Double-Dummy, Placebo-Controlled, Randomised, Adaptive, Dose-Range Study To Evaluate the Safety and Efficacy of SB-773812 Administered Once Daily for 12 Weeks in Adults With Schizophrenia

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.

Study Overview

Status

Completed

Conditions

Schizophrenia

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

338

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belgium
- - Liège, Belgium, 4000
    - GSK Investigational Site
  - Montignies-sur-Sambre, Belgium, 6061
    - GSK Investigational Site
Costa Rica
- - San José, Costa Rica
    - GSK Investigational Site
Czech Republic
- - Brno, Czech Republic, 625 00
    - GSK Investigational Site
  - Lnare, Czech Republic
    - GSK Investigational Site
  - Praha 8, Czech Republic, 181 00
    - GSK Investigational Site
India
- - Ahmedabad, India, 380010
    - GSK Investigational Site
  - Bangalore, India, 560034
    - GSK Investigational Site
  - Bangalore, India, 560010
    - GSK Investigational Site
  - Bangalore, India, 560029
    - GSK Investigational Site
  - Hyderabad, India, 500 034
    - GSK Investigational Site
  - Lucknow, India, 226003
    - GSK Investigational Site
  - Ludhiana, India, 141001
    - GSK Investigational Site
  - Mangalore, India, 575001
    - GSK Investigational Site
  - Pune, India, 411001
    - GSK Investigational Site
  - Tirupati, India, 517507
    - GSK Investigational Site
Peru
- Lima
  - Lima 18, Lima, Peru
    - GSK Investigational Site
Russian Federation
- - Leningraskaya region, Russian Federation, 188357
    - GSK Investigational Site
  - Moscow, Russian Federation, 115522
    - GSK Investigational Site
  - Moscow, Russian Federation, 119992
    - GSK Investigational Site
  - Moscow, Russian Federation, 107076
    - GSK Investigational Site
  - Nizhny Novgorod, Russian Federation, 603115
    - GSK Investigational Site
  - Saint-Petersburg, Russian Federation, 192019
    - GSK Investigational Site
  - Smolensk, Russian Federation, 214 019
    - GSK Investigational Site
  - St-Petersburg, Russian Federation, 197341
    - GSK Investigational Site
  - St. Petersburg, Russian Federation, 190121
    - GSK Investigational Site
  - St.Petersburg, Russian Federation, 193167
    - GSK Investigational Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - GSK Investigational Site
- California
  - Cerritos, California, United States, 90703
    - GSK Investigational Site
  - Garden Grove, California, United States, 92845
    - GSK Investigational Site
  - National City, California, United States, 91950
    - GSK Investigational Site
  - San Diego, California, United States, 92126
    - GSK Investigational Site
  - Upland, California, United States, 91786
    - GSK Investigational Site
- Connecticut
  - New Haven, Connecticut, United States, 06519
    - GSK Investigational Site
- District of Columbia
  - Washington, District of Columbia, United States, 20016
    - GSK Investigational Site
- Florida
  - North Miami, Florida, United States, 33161
    - GSK Investigational Site
- New Jersey
  - Clementon, New Jersey, United States, 08021
    - GSK Investigational Site
  - Kenilworth, New Jersey, United States, 07033
    - GSK Investigational Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87108
    - GSK Investigational Site
- New York
  - Orangeburg, New York, United States, 10962
    - GSK Investigational Site
- North Carolina
  - Butner, North Carolina, United States, 27509
    - GSK Investigational Site
- Ohio
  - Cincinnati, Ohio, United States, 45267
    - GSK Investigational Site
- Texas
  - Bellaire, Texas, United States, 77401
    - GSK Investigational Site
  - San Antonio, Texas, United States, 78229
    - GSK Investigational Site
- Virginia
  - Falls Church, Virginia, United States, 22041
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
total score for each SB-773812 dose versus placebo at Week 6. Time Frame: 12 Weeks	12 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluate safety of SB-773812 versus placebo and compared to olanzapine using PANNS scores -Measure the preliminary pharmacokinetic/pharmacodynamic relationships for SB-773812 -Assessment of movement disorders and cognitive functioning Time Frame: 12 Weeks	12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

November 30, 2005

First Submitted That Met QC Criteria