Schizophrenia Clinical Trial
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
| Verified date | March 2017 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 338 |
| Est. completion date | August 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | GSK Investigational Site | Liège | |
| Belgium | GSK Investigational Site | Montignies-sur-Sambre | |
| Costa Rica | GSK Investigational Site | San José | |
| Czech Republic | GSK Investigational Site | Brno | |
| Czech Republic | GSK Investigational Site | Lnare | |
| Czech Republic | GSK Investigational Site | Praha 8 | |
| India | GSK Investigational Site | Ahmedabad | |
| India | GSK Investigational Site | Bangalore | |
| India | GSK Investigational Site | Bangalore | |
| India | GSK Investigational Site | Bangalore | |
| India | GSK Investigational Site | Hyderabad | |
| India | GSK Investigational Site | Lucknow | |
| India | GSK Investigational Site | Ludhiana | |
| India | GSK Investigational Site | Mangalore | |
| India | GSK Investigational Site | Pune | |
| India | GSK Investigational Site | Tirupati | |
| Peru | GSK Investigational Site | Lima 18 | Lima |
| Russian Federation | GSK Investigational Site | Leningraskaya region | |
| Russian Federation | GSK Investigational Site | Moscow | |
| Russian Federation | GSK Investigational Site | Moscow | |
| Russian Federation | GSK Investigational Site | Moscow | |
| Russian Federation | GSK Investigational Site | Nizhny Novgorod | |
| Russian Federation | GSK Investigational Site | Saint-Petersburg | |
| Russian Federation | GSK Investigational Site | Smolensk | |
| Russian Federation | GSK Investigational Site | St-Petersburg | |
| Russian Federation | GSK Investigational Site | St. Petersburg | |
| Russian Federation | GSK Investigational Site | St.Petersburg | |
| United States | GSK Investigational Site | Albuquerque | New Mexico |
| United States | GSK Investigational Site | Bellaire | Texas |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Butner | North Carolina |
| United States | GSK Investigational Site | Cerritos | California |
| United States | GSK Investigational Site | Cincinnati | Ohio |
| United States | GSK Investigational Site | Clementon | New Jersey |
| United States | GSK Investigational Site | Falls Church | Virginia |
| United States | GSK Investigational Site | Garden Grove | California |
| United States | GSK Investigational Site | Kenilworth | New Jersey |
| United States | GSK Investigational Site | National City | California |
| United States | GSK Investigational Site | New Haven | Connecticut |
| United States | GSK Investigational Site | North Miami | Florida |
| United States | GSK Investigational Site | Orangeburg | New York |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | Upland | California |
| United States | GSK Investigational Site | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States, Belgium, Costa Rica, Czech Republic, India, Peru, Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | total score for each SB-773812 dose versus placebo at Week 6. | 12 Weeks | ||
| Secondary | 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 | 12 Weeks |
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