SchizophreniaPhase 2NCT00639483
Efficacy and Safety of Celecoxib as Add-on Therapy to Risperidone Versus Risperidone Alone in Patients With Schizophrenia
A Phase 2 study testing Celecoxib in people with Schizophrenia, run by Pfizer at 17 sites in 6 countries.
Trial summary
To assess the efficacy and safety of celecoxib as add-on therapy to risperidone versus risperidone alone in patients with schizophrenia Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 17 sitesin 6 countries
- Study dates
- Mar 2003to Jan 2004
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders [DSM]-IV-TR criteria and made by a specialist in psychiatry) and acute exacerbation of schizophrenia requiring hospitalization
- Total PANSS score of ?60 at screening
- History of schizophrenia of ?10 years (from onset of prodromal symptoms)
Who cannot join
- Axis-I DSM-IV-TR diagnosis other than schizophrenia
- Less than a full cycle has lapsed at time of screening following the last injection of a depot antipsychotic
- Currently taking celecoxib or other selective cyclo-oxygenase 2 inhibitors, or other antiinflammatory medication
Trial locations and contacts
17 sites in 6 countries.
17 sites in 6 countries
Brazil5 sites
Pfizer Investigational Site
Aparecida de Goiânia, Goiania, 74922-810
Pfizer Investigational Site
PR, Curitiba, 80520-000
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, 21944-970
Pfizer Investigational Site
Salvador, Estado de Bahia, 40325-090
Pfizer Investigational Site
São Paulo, São Paulo
Germany4 sites
Pfizer Investigational Site
Bonn, 53105
Pfizer Investigational Site
München, 80336
Pfizer Investigational Site
München, 81675
Pfizer Investigational Site
Münster
Argentina3 sites
Pfizer Investigational Site
La Plata, Buenos Aires, (1900)
Pfizer Investigational Site
La Plata, Pcia. de Buenos Aires, 1900
Pfizer Investigational Site
Lanus, Buenos Aires, 1824
Philippines2 sites
Pfizer Investigational Site
Mandaluyong, 1550
Pfizer Investigational Site
Pasig
Taiwan2 sites
Pfizer Investigational Site
Niao-Sung Hsiang, Kaohsiung
Pfizer Investigational Site
Taipei
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy of Celecoxib as Add-on Therapy to Risperidone Versus Risperidone Alone in Patients With Schizophrenia
To assess the efficacy and safety of celecoxib as add-on therapy to risperidone versus risperidone alone in patients with schizophrenia
- Conditions
- Schizophrenia
- Being tested
- Celecoxib, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
200 mg oral capsules twice daily as add-on therapy to risperidone twice daily (range 2-8 mg/day) for 11 weeks
PlaceboDrug
Matched oral placebo as add-on to risperidone twice daily (range 2-8 mg/day) for 11 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Celecoxib |
| B | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score
Measured: Week 11
Secondary outcomes (10)
Patient-Reported Outcomes using Treatment Satisfaction Questionnaire for Medication
Measured: Week 4 and 11
Physical examination
Measured: Week 11
Laboratory exams
Measured: Weeks 1, 2, 4, 6, 8, 11
Change from baseline in Global Improvement and Efficacy Index scores of Clinical Global Impressions scale of Psychosis
Measured: Weeks 4, 6, and 11
Change from baseline in total PANSS score
Measured: Weeks 4 and 6
Change from baseline in PANSS-derived Brief Psychiatric Rating Scale score
Measured: Weeks 4, 6, and 11
Change from baseline in combined PANSS Negative plus General Psychopathology Subscale Score and the separate PANSS Psychopathology Subscale Scores
Measured: Weeks 4, 6, and 11
Change from baseline in PANSS five-factor component scores
Measured: Weeks 4, 6, and 11
Time to onset of clinically meaningful improvement in total PANSS score
Measured: Weeks 1, 2, 4, 6, 8, and 11
Adverse events
Measured: Weeks 1, 2, 4, 6, 8, 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startMar 2003
- Study completionJan 2004
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 PfizerThe 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
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639483
- Sponsor's protocol ID
- COXXNT-6570-001
- Other IDs
- A3191105
- Status last verified
- Mar 2009
- First submitted
- 13 Mar 2008
- Last updated
- 16 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy of Celecoxib as Add-on Therapy to Risperidone Versus Risperidone Alone in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00639483
- Acronym / sponsor ID
- COXXNT-6570-001
- Conditions
- Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Study completion
- Jan 2004 (actual)
- First posted
- 20 Mar 2008 (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.
To assess the efficacy and safety of celecoxib as add-on therapy to risperidone versus risperidone alone in patients with schizophrenia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Celecoxib |
| B | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders [DSM]-IV-TR criteria and made by a specialist in psychiatry) and acute exacerbation of schizophrenia requiring hospitalization
- Total PANSS score of ?60 at screening
- History of schizophrenia of ?10 years (from onset of prodromal symptoms)
Key exclusion criteria (3 listed)
- Axis-I DSM-IV-TR diagnosis other than schizophrenia
- Less than a full cycle has lapsed at time of screening following the last injection of a depot antipsychotic
- Currently taking celecoxib or other selective cyclo-oxygenase 2 inhibitors, or other antiinflammatory medication
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 |
|---|---|---|
| Celecoxib200 mg oral capsules twice daily as add-on therapy to risperidone twice daily (range 2-8 mg/day) for 11 weeks | Drug | A |
| PlaceboMatched oral placebo as add-on to risperidone twice daily (range 2-8 mg/day) for 11 weeks | Drug | B |
Primary outcome
Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score
Time frame: Week 11
10 secondary outcomes
Patient-Reported Outcomes using Treatment Satisfaction Questionnaire for Medication
Time frame: Week 4 and 11
Physical examination
Time frame: Week 11
Laboratory exams
Time frame: Weeks 1, 2, 4, 6, 8, 11
Change from baseline in Global Improvement and Efficacy Index scores of Clinical Global Impressions scale of Psychosis
Time frame: Weeks 4, 6, and 11
Change from baseline in total PANSS score
Time frame: Weeks 4 and 6
Change from baseline in PANSS-derived Brief Psychiatric Rating Scale score
Time frame: Weeks 4, 6, and 11
Change from baseline in combined PANSS Negative plus General Psychopathology Subscale Score and the separate PANSS Psychopathology Subscale Scores
Time frame: Weeks 4, 6, and 11
Change from baseline in PANSS five-factor component scores
Time frame: Weeks 4, 6, and 11
Time to onset of clinically meaningful improvement in total PANSS score
Time frame: Weeks 1, 2, 4, 6, 8, and 11
Adverse events
Time frame: Weeks 1, 2, 4, 6, 8, 11
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 Mar 2009.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
Pfizer CT.gov Call Center study director
Pfizer
17 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celecoxib in people with Schizophrenia, run by Pfizer at 17 sites in 6 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 3 inclusion and 3 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 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Brazil, Germany, Argentina, Philippines, Taiwan and 1 more country. 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?
Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score (time frame: Week 11). 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 Mar 2009.