SB-773812 Administered In Adults With Schizophrenia

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00259870

Collaborator

(none)

338

Enrollment

Locations

Duration (Months)

7.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Sep 1, 2005

Actual Study Completion Date :

Aug 1, 2007

Outcome Measures

Primary Outcome Measures

total score for each SB-773812 dose versus placebo at Week 6. [12 Weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Birmingham	Alabama	United States	35233
2	GSK Investigational Site	Cerritos	California	United States	90703
3	GSK Investigational Site	Garden Grove	California	United States	92845
4	GSK Investigational Site	National City	California	United States	91950
5	GSK Investigational Site	San Diego	California	United States	92126
6	GSK Investigational Site	Upland	California	United States	91786
7	GSK Investigational Site	New Haven	Connecticut	United States	06519
8	GSK Investigational Site	Washington	District of Columbia	United States	20016
9	GSK Investigational Site	North Miami	Florida	United States	33161
10	GSK Investigational Site	Clementon	New Jersey	United States	08021
11	GSK Investigational Site	Kenilworth	New Jersey	United States	07033
12	GSK Investigational Site	Albuquerque	New Mexico	United States	87108
13	GSK Investigational Site	Orangeburg	New York	United States	10962
14	GSK Investigational Site	Butner	North Carolina	United States	27509
15	GSK Investigational Site	Cincinnati	Ohio	United States	45267
16	GSK Investigational Site	Bellaire	Texas	United States	77401
17	GSK Investigational Site	San Antonio	Texas	United States	78229
18	GSK Investigational Site	Falls Church	Virginia	United States	22041
19	GSK Investigational Site	Liège		Belgium	4000
20	GSK Investigational Site	Montignies-sur-Sambre		Belgium	6061
21	GSK Investigational Site	San José		Costa Rica
22	GSK Investigational Site	Brno		Czech Republic	625 00
23	GSK Investigational Site	Lnare		Czech Republic
24	GSK Investigational Site	Praha 8		Czech Republic	181 00
25	GSK Investigational Site	Ahmedabad		India	380010
26	GSK Investigational Site	Bangalore		India	560010
27	GSK Investigational Site	Bangalore		India	560029
28	GSK Investigational Site	Bangalore		India	560034
29	GSK Investigational Site	Hyderabad		India	500 034
30	GSK Investigational Site	Lucknow		India	226003
31	GSK Investigational Site	Ludhiana		India	141001
32	GSK Investigational Site	Mangalore		India	575001
33	GSK Investigational Site	Pune		India	411001
34	GSK Investigational Site	Tirupati		India	517507
35	GSK Investigational Site	Lima 18	Lima	Peru
36	GSK Investigational Site	Leningraskaya region		Russian Federation	188357
37	GSK Investigational Site	Moscow		Russian Federation	107076
38	GSK Investigational Site	Moscow		Russian Federation	115522
39	GSK Investigational Site	Moscow		Russian Federation	119992
40	GSK Investigational Site	Nizhny Novgorod		Russian Federation	603115
41	GSK Investigational Site	Saint-Petersburg		Russian Federation	192019
42	GSK Investigational Site	Smolensk		Russian Federation	214 019
43	GSK Investigational Site	St-Petersburg		Russian Federation	197341
44	GSK Investigational Site	St. Petersburg		Russian Federation	190121
45	GSK Investigational Site	St.Petersburg		Russian Federation	193167