Efficacy and Safety of Celecoxib as Add-on Therapy to Risperidone Versus Risperidone Alone in Patients With Schizophrenia

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639483
• Other study ID #: COXXNT-6570-001
• Secondary ID: A3191105
• Status: Completed
• Phase: Phase 2
• First received: March 13, 2008
• Last updated: March 12, 2009
• Start date: March 2003
• Est. completion date: January 2004

Study information

• Verified date: March 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

To assess the efficacy and safety of celecoxib as add-on therapy to risperidone versus risperidone alone in patients with schizophrenia

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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
Matched oral placebo as add-on to risperidone twice daily (range 2-8 mg/day) for 11 weeks

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	La Plata	Buenos Aires
Argentina	Pfizer Investigational Site	La Plata	Pcia. de Buenos Aires
Argentina	Pfizer Investigational Site	Lanús	Buenos Aires
Brazil	Pfizer Investigational Site	Aparecida de Goiania	Goiania
Brazil	Pfizer Investigational Site	PR	Curitiba
Brazil	Pfizer Investigational Site	Rio De Janeiro
Brazil	Pfizer Investigational Site	Salvador	BA
Brazil	Pfizer Investigational Site	Sao Paulo
Germany	Pfizer Investigational Site	Bonn
Germany	Pfizer Investigational Site	Muenchen
Germany	Pfizer Investigational Site	Muenchen
Germany	Pfizer Investigational Site	Munster
Mexico	Pfizer Investigational Site	Mexico City
Philippines	Pfizer Investigational Site	Mandaluyong City
Philippines	Pfizer Investigational Site	Pasig City
Taiwan	Pfizer Investigational Site	Niao-Sung Hsiang	Kaohsiung
Taiwan	Pfizer Investigational Site	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Argentina,  Brazil,  Germany,  Mexico,  Philippines,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score		Week 11	No
Secondary	Patient-Reported Outcomes using Treatment Satisfaction Questionnaire for Medication		Week 4 and 11	No
Secondary	Physical examination		Week 11	Yes
Secondary	Laboratory exams		Weeks 1, 2, 4, 6, 8, 11	Yes
Secondary	Change from baseline in Global Improvement and Efficacy Index scores of Clinical Global Impressions scale of Psychosis		Weeks 4, 6, and 11	No
Secondary	Change from baseline in total PANSS score		Weeks 4 and 6	No
Secondary	Change from baseline in PANSS-derived Brief Psychiatric Rating Scale score		Weeks 4, 6, and 11	No
Secondary	Change from baseline in combined PANSS Negative plus General Psychopathology Subscale Score and the separate PANSS Psychopathology Subscale Scores		Weeks 4, 6, and 11	No
Secondary	Change from baseline in PANSS five-factor component scores		Weeks 4, 6, and 11	No
Secondary	Time to onset of clinically meaningful improvement in total PANSS score		Weeks 1, 2, 4, 6, 8, and 11	No
Secondary	Adverse events		Weeks 1, 2, 4, 6, 8, 11	Yes

External Links

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