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

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00639483

First received: March 13, 2008

Last updated: March 12, 2009

Last verified: March 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

March 13, 2008

Last Updated Date

March 12, 2009

Start Date ^ICMJE

March 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score [ Time Frame: Week 11 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00639483 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

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

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

Drug: Celecoxib
200 mg oral capsules twice daily as add-on therapy to risperidone twice daily (range 2-8 mg/day) for 11 weeks
Drug: Placebo
Matched oral placebo as add-on to risperidone twice daily (range 2-8 mg/day) for 11 weeks

Study Arm (s)

Experimental: A
Intervention: Drug: Celecoxib
Placebo Comparator: B
Intervention: Drug: Placebo

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

Enrollment ^ICMJE

270

Completion Date

January 2004

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Argentina, Brazil, Germany, Mexico, Philippines, Taiwan

Administrative Information

NCT Number ^ICMJE

NCT00639483

Other Study ID Numbers ^ICMJE

COXXNT-6570-001, A3191105

Has Data Monitoring Committee

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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