Clinical trial NCT00259870: SB-773812 Administered In Adults With Schizophrenia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
PANSS
Acute
Cognition
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-12-01
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: total score for each SB-773812 dose versus placebo at Week 6.
timeFrame: 12 Weeks
Secondary outcomes:
measure: 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
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Cerritos
country: United States
facility: GSK Investigational Site
state: California
city: Garden Grove
country: United States
facility: GSK Investigational Site
state: California
city: National City
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Upland
country: United States
facility: GSK Investigational Site
state: California
city: New Haven
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: North Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Clementon
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Kenilworth
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: GSK Investigational Site
state: New Mexico
city: Orangeburg
country: United States
facility: GSK Investigational Site
state: New York
city: Butner
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Bellaire
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Falls Church
country: United States
facility: GSK Investigational Site
state: Virginia
city: Liège
country: Belgium
facility: GSK Investigational Site
city: Montignies-sur-Sambre
country: Belgium
facility: GSK Investigational Site
city: San José
country: Costa Rica
facility: GSK Investigational Site
city: Brno
country: Czech Republic
facility: GSK Investigational Site
city: Lnare
country: Czech Republic
facility: GSK Investigational Site
city: Praha 8
country: Czech Republic
facility: GSK Investigational Site
city: Ahmedabad
country: India
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Bangalore
country: India
facility: GSK Investigational Site
city: Hyderabad
country: India
facility: GSK Investigational Site
city: Lucknow
country: India
facility: GSK Investigational Site
city: Ludhiana
country: India
facility: GSK Investigational Site
city: Mangalore
country: India
facility: GSK Investigational Site
city: Pune
country: India
facility: GSK Investigational Site
city: Tirupati
country: India
facility: GSK Investigational Site
city: Lima 18
country: Peru
facility: GSK Investigational Site
state: Lima
city: Leningraskaya region
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Nizhny Novgorod
country: Russian Federation
facility: GSK Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Smolensk
country: Russian Federation
facility: GSK Investigational Site
city: St-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: St.Petersburg
country: Russian Federation
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: