Acute SchizophreniaPhase 3NCT00350467
A Randomized, Active-controlled, Double-blind, Parallel-Goup Study of the Efficacy and Safety of Extended Release(ER) Paliperidone in the Treatment of Schizophrenia
A Phase 3 study testing ER OROS paliperidone and Olanzapine in people with Acute Schizophrenia, run by Xian-Janssen Pharmaceutical Ltd. at 7 sites in China.
Trial summary
This is a randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), active-controlled, flexible-dose, parallel group, multicenter study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Schizophrenia
- What is being tested?
- ER OROS paliperidone and Olanzapine
- How many people
- 288 participants
- Where
- 7 sitesChina
- Study dates
- Jun 2006to Sep 2007
- Phase
- Phase 3
- 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
- Patients (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- DSM-IV diagnosis of schizophrenia (295.10, 295.20, 295.30, 295.60, 295.90) at entry
- Total PANSS score at screening and baseline between 60 and 120, inclusive
- Female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch) before entry (and agree to continue that method throughout the study) - abstinence is not an acceptable method
- have a negative urine b hCG pregnancy test at screening
- Capable of self-administering study drug, or has consistent help and support available throughout the study to do this
Who cannot join
- A DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) Axis I diagnosis other than schizophrenia
- Inability to swallow the study drug whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug, as this may affect the release profile)
- Previous history of a lack of response to any antipsychotic (lack of response defined as subject having had least twice a documented medical history of no clinical response despite adequate doses and durations of treatment, or the inability to tolerate effective doses)
- Significant risk of suicidal or violent behavior
- Injection of a depot antipsychotic within 120 days before screening, or use of paliperidone palmitate within 10 months before screening
- Use of monoamine oxidase inhibitors within 4 weeks before screening
- Use of antidepressants other than monoamine oxidase inhibitors or mood stabilizers (e.g., antiepileptics, lithium) within 2 weeks before screening
- Received electroconvulsive therapy within 3 months before screening
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Study site
Beijing, Beijing Municipality
Study site
Guangzhou, Guangdong
Study site
Nanjing, Jiangsu
Study site
Shanghai, Shanghai Municipality
Study site
Suzhou, Zhejiang
Study site
Wuhan, Hubei
Study site
Xi'an
About this study
Official title: A Randomized, 6-week Double-blind, Parallel Study to Evaluate the Efficacy and the Safety of Flexible Doses of Extended Release OROS Paliperidone Compared With Olanzapine in the Treatment of Patients With Schizophrenia
This is a randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), active-controlled, flexible-dose, parallel group, multicenter study. The study consists of a screening phase, a double-blind treatment phase (6 weeks) and a safety follow-up phase (1 week).
The patients in this study will be randomized to 1 of 2 treatment groups to receive extended release OROS paliperidone or Olanzapine once daily for the 6-week double-blind treatment phase. Randomization will occur in a ratio of 1 (extended release OROS paliperidone) to 1 (Olanzapine). Patients must be hospitalized at least 14 days after entry. Those who receive extended release OROS paliperidone will start at a dosage of 6 mg taken daily, dose may be titrated up by 3mg/day every 7 days, or down rapidly based on the balance of efficacy (effectiveness of drug) and safety/tolerability assessed by the investigator. After the initial 7 days, dose could be flexible within 3-12mg/day. Those who receive olanzapine will start at a dosage of 5mg taken daily, dose may be titrated up by 5mg/day every 7 days, or down rapidly based on the balance of efficacy and safety/tolerability assessed by the investigator. After the initial 7 days, dose could be flexible within 5-15mg/day.
Efficacy parameters include Positive and Negative Symptom Scale (PANSS) score, Clinical Global Impression-Severity (CGI-S) and Personal and Social Performance (PSP) score per assessment visit. The primary efficacy is the change in PANSS from baseline to the last post-randomization assessment. Safety assessments include the adverse events, changes in physical examination, vital signs, laboratory tests at pretreatment and posttreatment.
Read the detailed description
The study hypothesis is that the effect of extended release OROS paliperidone is not worse than that of Olanzapine in the treatment of schizophrenia as measured by the change in PANSS from baseline to the last post-randomization assessment. A flexible dose range is used in this study. The flexible dose of paliperidone is ranged from 3 to 12mg/day. The flexible dose of olanzapine is ranged from 5-15mg/day.The study medication is capsulized to maintain blind. Study medication must be taken orally once daily before 10 AM with or without food in a consistent manner throughout the study. Medication can not be chewed, divided, dissolved, or crushed. Treatment duration is 6 week each subject.
- Conditions
- Acute Schizophrenia
- Being tested
- ER OROS paliperidone and Olanzapine
- Keywords
- Schizophrenia, DSM-IV, PANSS, informed consent
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ER OROS paliperidone and OlanzapineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total PANSS score at endpoint (6-week double-blind or last assessment after baseline) from baseline.
Secondary outcomes (1)
Changes in PANSS positive and negative scores at each assessment time point from baseline; Changes in CGI-S at each assessment time point from baseline; Changes in PSP at each assessment time point from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startJun 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute SchizophreniaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Xian-Janssen Pharmaceutical Ltd. Clinical Trial, Study director, Xian-Janssen Pharmaceutical Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350467
- Sponsor's protocol ID
- CR010861
- Status last verified
- May 2010
- First submitted
- 7 Jul 2006
- Last updated
- 19 May 2011
- Results posted
- No
Publications
Fowler JA, Bettinger TL, Argo TR. Paliperidone extended-release tablets for the acute and maintenance treatment of schizophrenia. Clin Ther. 2008 Feb;30(2):231-48. doi: 10.1016/j.clinthera.2008.02.011.
PubMed 18343262
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, 6-week Double-blind, Parallel Study to Evaluate the Efficacy and the Safety of Flexible Doses of Extended Release OROS Paliperidone Compared With Olanzapine in the Treatment of Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00350467
- Acronym / sponsor ID
- CR010861
- Conditions
- Acute Schizophrenia
- Keywords
- Schizophrenia, DSM-IV, PANSS, informed consent
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 10 Jul 2006 (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 randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), active-controlled, flexible-dose, parallel group, multicenter study. The study consists of a screening phase, a double-blind treatment phase (6 weeks) and a safety follow-up phase (1 week).
The patients in this study will be randomized to 1 of 2 treatment groups to receive extended release OROS paliperidone or Olanzapine once daily for the 6-week double-blind treatment phase. Randomization will occur in a ratio of 1 (extended release OROS paliperidone) to 1 (Olanzapine). Patients must be hospitalized at least 14 days after entry. Those who receive extended release OROS paliperidone will start at a dosage of 6 mg taken daily, dose may be titrated up by 3mg/day every 7 days, or down rapidly based on the balance of efficacy (effectiveness of drug) and safety/tolerability assessed by the investigator. After the initial 7 days, dose could be flexible within 3-12mg/day. Those who receive olanzapine will start at a dosage of 5mg taken daily, dose may be titrated up by 5mg/day every 7 days, or down rapidly based on the balance of efficacy and safety/tolerability assessed by the investigator. After the initial 7 days, dose could be flexible within 5-15mg/day.
Efficacy parameters include Positive and Negative Symptom Scale (PANSS) score, Clinical Global Impression-Severity (CGI-S) and Personal and Social Performance (PSP) score per assessment visit. The primary efficacy is the change in PANSS from baseline to the last post-randomization assessment. Safety assessments include the adverse events, changes in physical examination, vital signs, laboratory tests at pretreatment and posttreatment.
Detailed description
The study hypothesis is that the effect of extended release OROS paliperidone is not worse than that of Olanzapine in the treatment of schizophrenia as measured by the change in PANSS from baseline to the last post-randomization assessment. A flexible dose range is used in this study. The flexible dose of paliperidone is ranged from 3 to 12mg/day. The flexible dose of olanzapine is ranged from 5-15mg/day.The study medication is capsulized to maintain blind. Study medication must be taken orally once daily before 10 AM with or without food in a consistent manner throughout the study. Medication can not be chewed, divided, dissolved, or crushed. Treatment duration is 6 week each subject.
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 (6 listed)
- Patients (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- DSM-IV diagnosis of schizophrenia (295.10, 295.20, 295.30, 295.60, 295.90) at entry
- Total PANSS score at screening and baseline between 60 and 120, inclusive
- Female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch) before entry (and agree to continue that method throughout the study) - abstinence is not an acceptable method
- have a negative urine b hCG pregnancy test at screening
Key exclusion criteria (8 listed)
- A DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) Axis I diagnosis other than schizophrenia
- Inability to swallow the study drug whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug, as this may affect the release profile)
- Previous history of a lack of response to any antipsychotic (lack of response defined as subject having had least twice a documented medical history of no clinical response despite adequate doses and durations of treatment, or the inability to tolerate effective doses)
- Significant risk of suicidal or violent behavior
- Injection of a depot antipsychotic within 120 days before screening, or use of paliperidone palmitate within 10 months before screening
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 |
|---|---|---|
| ER OROS paliperidone and Olanzapine | Drug | – |
Primary outcome
Change in total PANSS score at endpoint (6-week double-blind or last assessment after baseline) from baseline.
1 secondary outcome
Changes in PANSS positive and negative scores at each assessment time point from baseline; Changes in CGI-S at each assessment time point from baseline; Changes in PSP at each assessment time point from baseline
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 19 May 2011.
- Background: PubMed 18343262Fowler JA, Bettinger TL, Argo TR. Paliperidone extended-release tablets for the acute and maintenance treatment of schizophrenia. Clin Ther. 2008 Feb;30(2):231-48. doi: 10.1016/j.clinthera.2008.02.011.
- A Randomized, 6-Week Double Blind, Parallel Study to Evaluate the Efficacy and the Safety of Flexible Doses of Extended Release OROS Paliperidone Compared with Olanzapine in the Treatment of Patients With SchizophreniaLink provided by the sponsor.
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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.
Xian-Janssen Pharmaceutical Ltd. Clinical Trial study director
Xian-Janssen Pharmaceutical Ltd.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ER OROS paliperidone and Olanzapine in people with Acute Schizophrenia, run by Xian-Janssen Pharmaceutical Ltd. at 7 sites in China.
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 6 inclusion and 8 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 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 in total PANSS score at endpoint (6-week double-blind or last assessment after baseline) from baseline.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00350467, which also lists 1 linked publication.
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 19 May 2011.