SchizophreniaPhase 2NCT00259870
SB-773812 Administered In Adults With Schizophrenia
A Phase 2 study testing SB-773812 and Olanzapine in people with Schizophrenia, run by GlaxoSmithKline at 45 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- SB-773812 and Olanzapine
- How many people
- 338 participants
- Where
- 45 sitesin 7 countries
- Study dates
- Sep 2005to Aug 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
45 sites in 7 countries.
45 sites in 7 countries
United States18 sites
GSK Investigational Site
Albuquerque, New Mexico, 87108
GSK Investigational Site
Bellaire, Texas, 77401
GSK Investigational Site
Birmingham, Alabama, 35233
GSK Investigational Site
Butner, North Carolina, 27509
GSK Investigational Site
Cerritos, California, 90703
GSK Investigational Site
Cincinnati, Ohio, 45267
GSK Investigational Site
Clementon, New Jersey, 08021
GSK Investigational Site
Falls Church, Virginia, 22041
GSK Investigational Site
Garden Grove, California, 92845
GSK Investigational Site
Kenilworth, New Jersey, 07033
GSK Investigational Site
National City, California, 91950
GSK Investigational Site
New Haven, Connecticut, 06519
GSK Investigational Site
North Miami, Florida, 33161
GSK Investigational Site
Orangeburg, New York, 10962
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Diego, California, 92126
GSK Investigational Site
Upland, California, 91786
GSK Investigational Site
Washington D.C., District of Columbia, 20016
India10 sites
GSK Investigational Site
Ahmedabad, 380010
GSK Investigational Site
Bangalore, 560010
GSK Investigational Site
Bangalore, 560029
GSK Investigational Site
Bangalore, 560034
GSK Investigational Site
Hyderabad, 500 034
GSK Investigational Site
Lucknow, 226003
GSK Investigational Site
Ludhiana, 141001
GSK Investigational Site
Mangalore, 575001
GSK Investigational Site
Pune, 411001
GSK Investigational Site
Tirupati, 517507
Russia10 sites
GSK Investigational Site
Leningraskaya Region, 188357
GSK Investigational Site
Moscow, 107076
GSK Investigational Site
Moscow, 115522
GSK Investigational Site
Moscow, 119992
GSK Investigational Site
Nizhny Novgorod, 603115
GSK Investigational Site
Saint Petersburg, 190121
GSK Investigational Site
Saint Petersburg, 192019
GSK Investigational Site
Saint Petersburg, 193167
GSK Investigational Site
Saint Petersburg, 197341
GSK Investigational Site
Smolensk, 214 019
Czechia3 sites
GSK Investigational Site
Brno, 625 00
GSK Investigational Site
Lnáře
GSK Investigational Site
Prague, 181 00
Belgium2 sites
GSK Investigational Site
Liège, 4000
GSK Investigational Site
Montignies-sur-Sambre, 6061
About this study
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
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.
- Conditions
- Schizophrenia
- Being tested
- SB-773812, Olanzapine
- Keywords
- Schizophrenia, PANSS, Acute, Cognition
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-773812Drug
OlanzapineDrug
Also called SB-773812
What is being measured
The primary outcome is the main question the study is designed to answer.
total score for each SB-773812 dose versus placebo at Week 6.
Measured: 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
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startSep 2005
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259870
- Sponsor's protocol ID
- NAA104606
- Status last verified
- Mar 2017
- First submitted
- 30 Nov 2005
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00259870
- Acronym / sponsor ID
- NAA104606
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, PANSS, Acute, Cognition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Study completion
- Aug 2007 (actual)
- First posted
- 1 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SB-773812 | Drug | – |
| OlanzapineAlso: SB-773812 | Drug | – |
Primary outcome
total score for each SB-773812 dose versus placebo at Week 6.
Time frame: 12 Weeks
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
45 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SB-773812 and Olanzapine in people with Schizophrenia, run by GlaxoSmithKline at 45 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, India, Russia, Czechia, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total score for each SB-773812 dose versus placebo at Week 6. (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.