Efficacy and Safety of Celecoxib as Add-on Therapy to Risperidone Versus Risperidone Alone in Patients With Schizophrenia
- Registration Number
- NCT00639483
- Lead Sponsor
- Pfizer
- Brief Summary
To assess the efficacy and safety of celecoxib as add-on therapy to risperidone versus risperidone alone in patients with schizophrenia
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Placebo - A Celecoxib -
- Primary Outcome Measures
Name Time Method Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score Week 11
- Secondary Outcome Measures
Name Time Method Physical examination Week 11 Laboratory exams Weeks 1, 2, 4, 6, 8, 11 Patient-Reported Outcomes using Treatment Satisfaction Questionnaire for Medication Week 4 and 11 Change from baseline in Global Improvement and Efficacy Index scores of Clinical Global Impressions scale of Psychosis Weeks 4, 6, and 11 Change from baseline in total PANSS score Weeks 4 and 6 Change from baseline in PANSS-derived Brief Psychiatric Rating Scale score Weeks 4, 6, and 11 Change from baseline in combined PANSS Negative plus General Psychopathology Subscale Score and the separate PANSS Psychopathology Subscale Scores Weeks 4, 6, and 11 Change from baseline in PANSS five-factor component scores Weeks 4, 6, and 11 Adverse events Weeks 1, 2, 4, 6, 8, 11 Time to onset of clinically meaningful improvement in total PANSS score Weeks 1, 2, 4, 6, 8, and 11
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇨🇳Taipei, Taiwan