Efficacy and Safety of Celecoxib as Add-on Therapy to Risperidone Versus Risperidone Alone in Patients With Schizophrenia
NCT00639483
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- 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)
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Efficacy and Safety of Celecoxib as Add-on Therapy to Risperidone Versus Risperidone Alone in Patients With Schizophrenia | |||
Official Title ICMJE | 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 | |||
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 Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Schizophrenia | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 270 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | January 2004 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Brazil, Germany, Mexico, Philippines, Taiwan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00639483 | |||
Other Study ID Numbers ICMJE | COXXNT-6570-001 A3191105 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | March 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |