Efficacy and Safety of Celecoxib as Add-on Therapy to Risperidone Versus Risperidone Alone in Patients With Schizophrenia
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00639483
First received: March 13, 2008
Last updated: March 12, 2009
Last verified: March 2009
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Purpose
To assess the efficacy and safety of celecoxib as add-on therapy to risperidone versus risperidone alone in patients with schizophrenia
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Celecoxib Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score [ Time Frame: Week 11 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Patient-Reported Outcomes using Treatment Satisfaction Questionnaire for Medication [ Time Frame: Week 4 and 11 ] [ Designated as safety issue: No ]
- Physical examination [ Time Frame: Week 11 ] [ Designated as safety issue: Yes ]
- Laboratory exams [ Time Frame: Weeks 1, 2, 4, 6, 8, 11 ] [ Designated as safety issue: Yes ]
- Change from baseline in Global Improvement and Efficacy Index scores of Clinical Global Impressions scale of Psychosis [ Time Frame: Weeks 4, 6, and 11 ] [ Designated as safety issue: No ]
- Change from baseline in total PANSS score [ Time Frame: Weeks 4 and 6 ] [ Designated as safety issue: No ]
- Change from baseline in PANSS-derived Brief Psychiatric Rating Scale score [ Time Frame: Weeks 4, 6, and 11 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Change from baseline in PANSS five-factor component scores [ Time Frame: Weeks 4, 6, and 11 ] [ Designated as safety issue: No ]
- Time to onset of clinically meaningful improvement in total PANSS score [ Time Frame: Weeks 1, 2, 4, 6, 8, and 11 ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: Weeks 1, 2, 4, 6, 8, 11 ] [ Designated as safety issue: Yes ]
| Enrollment: | 270 |
| Study Start Date: | March 2003 |
| Study Completion Date: | January 2004 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: Celecoxib
200 mg oral capsules twice daily as add-on therapy to risperidone twice daily (range 2-8 mg/day) for 11 weeks
|
| Placebo Comparator: B |
Drug: Placebo
Matched oral placebo as add-on to risperidone twice daily (range 2-8 mg/day) for 11 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- 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)
Exclusion criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639483
Locations
| Argentina | |
| Pfizer Investigational Site | |
| La Plata, Buenos Aires, Argentina, (1900) | |
| Pfizer Investigational Site | |
| Lanús, Buenos Aires, Argentina, 1824 | |
| Pfizer Investigational Site | |
| La Plata, Pcia. de Buenos Aires, Argentina, 1900 | |
| Brazil | |
| Pfizer Investigational Site | |
| Salvador, BA, Brazil, 40325-090 | |
| Pfizer Investigational Site | |
| PR, Curitiba, Brazil, 80520-000 | |
| Pfizer Investigational Site | |
| Aparecida de Goiania, Goiania, Brazil, 74922-810 | |
| Pfizer Investigational Site | |
| Rio De Janeiro, Brazil, 21944-970 | |
| Pfizer Investigational Site | |
| Sao Paulo, Brazil | |
| Germany | |
| Pfizer Investigational Site | |
| Bonn, Germany, 53105 | |
| Pfizer Investigational Site | |
| Muenchen, Germany, 80336 | |
| Pfizer Investigational Site | |
| Muenchen, Germany, 81675 | |
| Pfizer Investigational Site | |
| Munster, Germany | |
| Mexico | |
| Pfizer Investigational Site | |
| Mexico City, Mexico, CP-14370 | |
| Philippines | |
| Pfizer Investigational Site | |
| Mandaluyong City, Philippines, 1550 | |
| Pfizer Investigational Site | |
| Pasig City, Philippines | |
| Taiwan | |
| Pfizer Investigational Site | |
| Niao-Sung Hsiang, Kaohsiung, Taiwan | |
| Pfizer Investigational Site | |
| Taipei, Taiwan | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00639483 History of Changes |
| Other Study ID Numbers: | COXXNT-6570-001, A3191105 |
| Study First Received: | March 13, 2008 |
| Last Updated: | March 12, 2009 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Risperidone Celecoxib Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents |
Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 23, 2013