SB-773812 Administered In Adults With Schizophrenia

Completed · Phase 2

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT00259870

Run by

GlaxoSmithKline

People needed

338

Starts

2005-09-01

Expected to finish

2007-08-01

Last updated by the study team

2017-03-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Cerritos, California, United States
• GSK Investigational Site — Garden Grove, California, United States
• GSK Investigational Site — National City, California, United States
• GSK Investigational Site — San Diego, California, United States
• GSK Investigational Site — Upland, California, United States
• GSK Investigational Site — New Haven, Connecticut, United States
• GSK Investigational Site — Washington D.C., District of Columbia, United States
• GSK Investigational Site — North Miami, Florida, United States
• GSK Investigational Site — Clementon, New Jersey, United States
• GSK Investigational Site — Kenilworth, New Jersey, United States
• GSK Investigational Site — Albuquerque, New Mexico, United States
• GSK Investigational Site — Orangeburg, New York, United States
• GSK Investigational Site — Butner, North Carolina, United States
• GSK Investigational Site — Cincinnati, Ohio, United States
• GSK Investigational Site — Bellaire, Texas, United States
• GSK Investigational Site — San Antonio, Texas, United States
• GSK Investigational Site — Falls Church, Virginia, United States
• GSK Investigational Site — Liège, Belgium
• GSK Investigational Site — Montignies-sur-Sambre, Belgium
• GSK Investigational Site — San José, Costa Rica
• GSK Investigational Site — Brno, Czechia
• GSK Investigational Site — Lnáře, Czechia
• GSK Investigational Site — Prague, Czechia
• GSK Investigational Site — Ahmedabad, India

Full record on ClinicalTrials.gov

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