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Completed

NCT Number: NCT00259870

SB-773812 Administered 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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Liège, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SB-773812

Drug

Olanzapine

Drug

Other names: SB-773812

Primary outcomes

  1. total score for each SB-773812 dose versus placebo at Week 6.

    Time frame: 12 Weeks

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2007
First posted
Dec 1, 2005
Registry last updated
Mar 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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