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Celecoxib add-on to Risperidone in Schizophrenia
NCT00639483Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2003
- Countries
- 6
- Sponsor
- Pfizer
- Modality
- Small Molecules
- Conditions
- schizophrenia
01
Overview
Phase 2, randomised, double-blind trial of celecoxib oral solution in schizophrenia (2 arms), sponsored by Pfizer. Primary endpoint: Change from baseline in total Positive and Negative Syndrome Scale score at 11 weeks. Started Mar 2003; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Celecoxib + Risperidone
Celecoxib 200 mg BID + Risperidone 2-8 mg/day
Placebo + Risperidone
Placebo + Risperidone 2-8 mg/day
03
Who it enrols
Patients with acute exacerbation of schizophrenia requiring hospitalization, a history of schizophrenia of at least 10 years, and a PANSS score of at least 60.
04
Endpoints
Primary
Change from baseline in total Positive and Negative Syndrome Scale score
Secondary
Treatment Satisfaction Questionnaire for Medication
Physical examination
Laboratory exams
Clinical Global Impressions - Global Improvement and Efficacy Index
Change from baseline in total PANSS score
Brief Psychiatric Rating Scale score
PANSS Negative plus General Psychopathology Subscale Score and separate PANSS Psychopathology Subscale Scores
PANSS five-factor component scores
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