SchizophreniaPhase 2NCT00103727
Study Of Talnetant Versus Placebo And Risperidone In Schizophrenia
A Phase 2 study testing Talnetant and risperidone in people with Schizophrenia, run by GlaxoSmithKline at 22 sites in United States.
Trial summary
This study will evaluate whether talnetant (200mg, 400mg, 600mg) twice a day is effective compared to placebo and risperidone 1-3mg twice a day in treating the positive and negative symptoms of 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 282 participants
- Where
- 22 sitesUnited States
- Study dates
- Dec 2004to Oct 2005
- 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
- Subjects must have schizophrenia which is not secondary to another medical condition or substance abuse.
- Require inpatient hospitalization.
- Woman may enroll only if they are not of child-bearing potential OR are on a protocol-approved birth control method.
Who cannot join
- Subject is in their first episode of schizophrenia.
- Subject has other psychotic disorders or bipolar disorder.
- Subject has schizophrenia symptoms from taking another medicine or drug of abuse, or due to a general medical condition.
- Subject has a recent history of substance dependence/dependence, or tests positive for illicit drug.
- Subject has an unstable medical disorder, or any significant medical disorder including autistic disorder, organic brain disease, liver dysfunction, epilepsy or seizures, or is at increased risk of developing cerebrovascular problems like stroke.
- Subject has any significant abnormalities in any of the screening tests (ECGs, labs, physical examinations, etc.).
Show all 13Show fewer
- Subject poses a current serious suicidal or homicidal risk.
- Subject has a positive pregnancy test, or is lactating or planning to become pregnant within one month of the study.
- Subject has recently or is currently participating in another clinical study.
- Subject is stabilized on their current schizophrenia treatment.
- Subject needs to take any of the medicines not permitted in the study, or has recently had ECT (electroconvulsive therapy) or TMS (transcranial magnetic stimulation).
- Subject was non-responsive to two or more adequate trials of antipsychotic treatments over the past 2 years.
- Subject has had an allergic or significant reaction to any of the study drugs, or can't take risperidone.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
GSK Investigational Site
Anaheim, California, 92805
GSK Investigational Site
Atlanta, Georgia, 30308
GSK Investigational Site
Austin, Texas, 78756
GSK Investigational Site
Cerritos, California, 90703
GSK Investigational Site
Clementon, New Jersey, 08021
GSK Investigational Site
Garden Grove, California, 92845
GSK Investigational Site
Glendale, California, 91206
GSK Investigational Site
Irving, Texas, 75062
GSK Investigational Site
Little Rock, Arkansas, 72201
GSK Investigational Site
National City, California, 91950
GSK Investigational Site
North Miami, Florida, 33161
GSK Investigational Site
Oak Brook, Illinois, 60523
GSK Investigational Site
Oceanside, California, 92056
GSK Investigational Site
Philadelphia, Pennsylvania, 19131
GSK Investigational Site
Pico Rivera, California, 90660
GSK Investigational Site
Richmond, Virginia, 23294
GSK Investigational Site
Rosemead, California, 91770
GSK Investigational Site
San Diego, California, 92123
GSK Investigational Site
San Diego, California, 92126
GSK Investigational Site
St Louis, Missouri, 63118
GSK Investigational Site
Upland, California, 91786
GSK Investigational Site
Washington D.C., District of Columbia, 20016
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
This study will evaluate whether talnetant (200mg, 400mg, 600mg) twice a day is effective compared to placebo and risperidone 1-3mg twice a day in treating the positive and negative symptoms of schizophrenia. Study subjects will be treated with study drug for up to 6 weeks and will then return for a follow-up visit 2 weeks later. About 275 patients with schizophrenia will be enrolled in this study.
- Conditions
- Schizophrenia
- Being tested
- Talnetant, placebo, risperidone
- Keywords
- paranoid, catatonic, undifferentiated types, disorganized
- Medical subject headings
- Schizophrenia, Catatonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TalnetantDrug
talnetant
placeboOther
Placebo Comparator
risperidoneOther
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| talnetant | Experimental | 200mg, 400mg, 600mg) twice a day Receives: Drug: Talnetant |
| placebo | Placebo comparator | placebo Receives: Other: placebo |
| risperidone | Active comparator | 3mg twice a day Receives: Other: risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is change in the Positive and Negative Syndrome Scale (PANSS) at Week 6 compared to baseline values.
Measured: 6 weeks
Secondary outcomes (1)
The secondary measures assess both efficacy (cognition, depression) as well as a variety of safety/tolerability endpoints (adverse events, motor function, laboratory measures).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2005 (estimated)
- Study startDec 2004
- Primary completionOct 2005
- Study completionOct 2005
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
- Who is masked
- Participant, Investigator
- Enrolment
- 282 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
- NCT00103727
- Sponsor's protocol ID
- SB-223412/093
- Status last verified
- Apr 2015
- First submitted
- 14 Feb 2005
- Last updated
- 29 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. 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
- NCT00103727
- Acronym / sponsor ID
- SB-223412/093
- Conditions
- Schizophrenia
- Keywords
- paranoid, catatonic, undifferentiated types, disorganized
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 15 Feb 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 study will evaluate whether talnetant (200mg, 400mg, 600mg) twice a day is effective compared to placebo and risperidone 1-3mg twice a day in treating the positive and negative symptoms of schizophrenia. Study subjects will be treated with study drug for up to 6 weeks and will then return for a follow-up visit 2 weeks later. About 275 patients with schizophrenia will be enrolled in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| talnetant | Experimental | Drug: Talnetant200mg, 400mg, 600mg) twice a day |
| placebo | Placebo comparator | Other: placeboplacebo |
| risperidone | Active comparator | Other: risperidone3mg twice a day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must have schizophrenia which is not secondary to another medical condition or substance abuse.
- Require inpatient hospitalization.
- Woman may enroll only if they are not of child-bearing potential OR are on a protocol-approved birth control method.
Key exclusion criteria (13 listed)
- Subject is in their first episode of schizophrenia.
- Subject has other psychotic disorders or bipolar disorder.
- Subject has schizophrenia symptoms from taking another medicine or drug of abuse, or due to a general medical condition.
- Subject has a recent history of substance dependence/dependence, or tests positive for illicit drug.
- Subject has an unstable medical disorder, or any significant medical disorder including autistic disorder, organic brain disease, liver dysfunction, epilepsy or seizures, or is at increased risk of developing cerebrovascular problems like stroke.
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 |
|---|---|---|
| Talnetanttalnetant | Drug | talnetant |
| placeboPlacebo Comparator | Other | placebo |
| risperidoneActive Comparator | Other | risperidone |
Primary outcome
The primary outcome measure is change in the Positive and Negative Syndrome Scale (PANSS) at Week 6 compared to baseline values.
Time frame: 6 weeks
1 secondary outcome
The secondary measures assess both efficacy (cognition, depression) as well as a variety of safety/tolerability endpoints (adverse events, motor function, laboratory measures).
Time frame: 6 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 29 Apr 2015.
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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
22 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 22 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 3 inclusion and 13 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 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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. Some participants in this study may receive a placebo. 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?
The primary outcome measure is change in the Positive and Negative Syndrome Scale (PANSS) at Week 6 compared to baseline values. (time frame: 6 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 29 Apr 2015.