Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

SB-773812 Administered In Adults With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00259870
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: SB-773812 Drug: Olanzapine Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 338 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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
Study Start Date : September 2005
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Olanzapine


Intervention Details:
  • Drug: SB-773812
  • Drug: Olanzapine
    Other Name: SB-773812


Primary Outcome Measures :
  1. total score for each SB-773812 dose versus placebo at Week 6. [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259870


Locations
Layout table for location information
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35233
United States, California
GSK Investigational Site
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
United States, Connecticut
GSK Investigational Site
New Haven, Connecticut, United States, 06519
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20016
United States, Florida
GSK Investigational Site
North Miami, Florida, United States, 33161
United States, New Jersey
GSK Investigational Site
Clementon, New Jersey, United States, 08021
GSK Investigational Site
Kenilworth, New Jersey, United States, 07033
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
United States, New York
GSK Investigational Site
Orangeburg, New York, United States, 10962
United States, North Carolina
GSK Investigational Site
Butner, North Carolina, United States, 27509
United States, Ohio
GSK Investigational Site
Cincinnati, Ohio, United States, 45267
United States, Texas
GSK Investigational Site
Bellaire, Texas, United States, 77401
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, Virginia
GSK Investigational Site
Falls Church, Virginia, United States, 22041
Belgium
GSK Investigational Site
Liège, Belgium, 4000
GSK Investigational Site
Montignies-sur-Sambre, Belgium, 6061
Costa Rica
GSK Investigational Site
San José, Costa Rica
Czech Republic
GSK Investigational Site
Brno, Czech Republic, 625 00
GSK Investigational Site
Lnare, Czech Republic
GSK Investigational Site
Praha 8, Czech Republic, 181 00
India
GSK Investigational Site
Ahmedabad, India, 380010
GSK Investigational Site
Bangalore, India, 560010
GSK Investigational Site
Bangalore, India, 560029
GSK Investigational Site
Bangalore, India, 560034
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
Peru
GSK Investigational Site
Lima 18, Lima, Peru
Russian Federation
GSK Investigational Site
Leningraskaya region, Russian Federation, 188357
GSK Investigational Site
Moscow, Russian Federation, 107076
GSK Investigational Site
Moscow, Russian Federation, 115522
GSK Investigational Site
Moscow, Russian Federation, 119992
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
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline

Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00259870    
Other Study ID Numbers: NAA104606
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017
Keywords provided by GlaxoSmithKline:
Schizophrenia
PANSS
Acute
Cognition
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents