SchizophreniaPhase 2NCT00049946
Schizophrenia Study In Adults
A Phase 2 study testing talnetant and risperidone in people with Schizophrenia, run by GlaxoSmithKline at 31 sites in United States.
Trial summary
A Placebo Controlled Study For Patients With Schizophrenia Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- talnetant and risperidone
- How many people
- 231 participants
- Where
- 31 sitesUnited States
- Study dates
- Oct 2002to Apr 2003
- 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
- Patient must meet diagnostic criteria for schizophrenia.
Who cannot join
- Patients with other psychotic disorders.
- Patients whose condition is due to the direct physiological effects of a substances (e.g., drug abuse) or a general medical condition.
- Patients with a history of autistic disorder or another pervasive developmental disorder.
- Patients with epilepsy or a history of seizures requiring treatment.
- Patients who are excluded from taking the drug risperidone.
- Patients who pose a current serious suicidal or homicidal risk.
- Patients who are adequately stabilized on their treatment.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
GSK Clinical Trial Call Center
Austin, Texas, 78729
GSK Clinical Trial Call Center
Bellaire, Texas, 77401
GSK Clinical Trial Call Center
Butner, North Carolina, 27509
GSK Clinical Trial Call Center
Cerritos, California, 90703
GSK Clinical Trial Call Center
Chula Vista, California, 91910
GSK Clinical Trial Call Center
Cincinnati, Ohio, 45267
GSK Clinical Trial Call Center
Clementon, New Jersey, 08021
GSK Clinical Trial Call Center
Cleveland, Ohio, 44109
GSK Clinical Trial Call Center
Garden Grove, California, 92845
GSK Clinical Trial Call Center
Greenwood, Indiana, 46143
GSK Clinical Trial Call Center
Hoffman Estates, Illinois, 60194
GSK Clinical Trial Call Center
Hollis, New York, 11423
GSK Clinical Trial Call Center
Nashville, Tennessee, 37212
GSK Clinical Trial Call Center
New Britain, Connecticut, 06050
GSK Clinical Trial Call Center
New Haven, Connecticut, 06519
GSK Clinical Trial Call Center
Norman, Oklahoma, 73069
GSK Clinical Trial Call Center
North Miami, Florida, 33161
GSK Clinical Trial Call Center
Oklahoma City, Oklahoma, 73103
GSK Clinical Trial Call Center
Orange, California, 92868
GSK Clinical Trial Call Center
Pico Rivera, California, 90660
GSK Clinical Trial Call Center
Raleigh, North Carolina, 27603
GSK Clinical Trial Call Center
Rosemead, California, 91770
GSK Clinical Trial Call Center
Sacramento, California, 95823
GSK Clinical Trial Call Center
San Diego, California, 92123
GSK Clinical Trial Call Center
San Diego, California, 92126
GSK Clinical Trial Call Center
Scottsdale, Arizona, 85251
GSK Clinical Trial Call Center
Shreveport, Louisiana, 71101
GSK Clinical Trial Call Center
Tampa, Florida, 33613
GSK Clinical Trial Call Center
Terrell, Texas, 75160
GSK Clinical Trial Call Center
Washington D.C., District of Columbia, 20016
GSK Clinical Trial Call Center
Winter Park, Florida, 32789
About this study
Official title: A Multicenter, Double-Blind, Double-Dummy, Placebo-Controlled, Randomized, Parallel Group Evaluation of the Efficacy and Safety of a Fixed-Dose of Talnetant Versus Placebo Versus Risperidone in Subjects With Schizophrenia
A Placebo Controlled Study For Patients With Schizophrenia
- Conditions
- Schizophrenia
- Being tested
- talnetant, risperidone
- Keywords
- Talnetant, schizophrenia, NK3 receptor antagonist, psychosis
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
talnetantDrug
risperidoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the PANSS total score.
Secondary outcomes (1)
Secondary measures assessed efficacy, safety & tolerability endpoints using the PANSS, BPRS Psychosis score, CGI-S, CGI-GI, Calgary Depression Scale for Schizophrenia, Brief Assessment of Cognition for Schizophrenia, and others.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2002 (estimated)
- Study startOct 2002
- Primary completionApr 2003
- Study completionApr 2003
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
- 231 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00049946
- Sponsor's protocol ID
- SB223412/078
- Status last verified
- Aug 2017
- First submitted
- 15 Nov 2002
- Last updated
- 16 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Double-Dummy, Placebo-Controlled, Randomized, Parallel Group Evaluation of the Efficacy and Safety of a Fixed-Dose of Talnetant Versus Placebo Versus Risperidone in Subjects With Schizophrenia
- ClinicalTrials.gov ID
- NCT00049946
- Acronym / sponsor ID
- SB223412/078
- Conditions
- Schizophrenia
- Keywords
- Talnetant, schizophrenia, NK3 receptor antagonist, psychosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Primary completion
- Apr 2003 (actual)
- Study completion
- Apr 2003 (actual)
- First posted
- 18 Nov 2002 (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.
A Placebo Controlled Study For Patients With Schizophrenia
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 (1 listed)
- Patient must meet diagnostic criteria for schizophrenia.
Key exclusion criteria (7 listed)
- Patients with other psychotic disorders.
- Patients whose condition is due to the direct physiological effects of a substances (e.g., drug abuse) or a general medical condition.
- Patients with a history of autistic disorder or another pervasive developmental disorder.
- Patients with epilepsy or a history of seizures requiring treatment.
- Patients who are excluded from taking the drug risperidone.
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 |
|---|---|---|
| talnetant | Drug | – |
| risperidone | Drug | – |
Primary outcome
Change from baseline in the PANSS total score.
1 secondary outcome
Secondary measures assessed efficacy, safety & tolerability endpoints using the PANSS, BPRS Psychosis score, CGI-S, CGI-GI, Calgary Depression Scale for Schizophrenia, Brief Assessment of Cognition for Schizophrenia, and others.
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 16 Aug 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, MD study director
GlaxoSmithKline
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing talnetant and risperidone in people with Schizophrenia, run by GlaxoSmithKline at 31 sites in United States.
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 1 inclusion and 7 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 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. 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?
Change from baseline in the PANSS total score.. 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 16 Aug 2017.