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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Celecoxib
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score

Secondary Outcome Measures

Patient-Reported Outcomes using Treatment Satisfaction Questionnaire for Medication
Physical examination
Laboratory exams
Change from baseline in Global Improvement and Efficacy Index scores of Clinical Global Impressions scale of Psychosis
Change from baseline in total PANSS score
Change from baseline in PANSS-derived Brief Psychiatric Rating Scale score
Change from baseline in combined PANSS Negative plus General Psychopathology Subscale Score and the separate PANSS Psychopathology Subscale Scores
Change from baseline in PANSS five-factor component scores
Time to onset of clinically meaningful improvement in total PANSS score
Adverse events

Full Information

First Posted
March 13, 2008
Last Updated
March 12, 2009
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00639483
Brief Title
Efficacy and Safety of Celecoxib as Add-on Therapy to Risperidone Versus Risperidone Alone in Patients With Schizophrenia
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Description
200 mg oral capsules twice daily as add-on therapy to risperidone twice daily (range 2-8 mg/day) for 11 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matched oral placebo as add-on to risperidone twice daily (range 2-8 mg/day) for 11 weeks
Primary Outcome Measure Information:
Title
Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score
Time Frame
Week 11
Secondary Outcome Measure Information:
Title
Patient-Reported Outcomes using Treatment Satisfaction Questionnaire for Medication
Time Frame
Week 4 and 11
Title
Physical examination
Time Frame
Week 11
Title
Laboratory exams
Time Frame
Weeks 1, 2, 4, 6, 8, 11
Title
Change from baseline in Global Improvement and Efficacy Index scores of Clinical Global Impressions scale of Psychosis
Time Frame
Weeks 4, 6, and 11
Title
Change from baseline in total PANSS score
Time Frame
Weeks 4 and 6
Title
Change from baseline in PANSS-derived Brief Psychiatric Rating Scale score
Time Frame
Weeks 4, 6, and 11
Title
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
Title
Change from baseline in PANSS five-factor component scores
Time Frame
Weeks 4, 6, and 11
Title
Time to onset of clinically meaningful improvement in total PANSS score
Time Frame
Weeks 1, 2, 4, 6, 8, and 11
Title
Adverse events
Time Frame
Weeks 1, 2, 4, 6, 8, 11

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
(1900)
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Lanús
State/Province
Buenos Aires
ZIP/Postal Code
1824
Country
Argentina
Facility Name
Pfizer Investigational Site
City
La Plata
State/Province
Pcia. de Buenos Aires
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Salvador
State/Province
BA
ZIP/Postal Code
40325-090
Country
Brazil
Facility Name
Pfizer Investigational Site
City
PR
State/Province
Curitiba
ZIP/Postal Code
80520-000
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Aparecida de Goiania
State/Province
Goiania
ZIP/Postal Code
74922-810
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Rio De Janeiro
ZIP/Postal Code
21944-970
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Sao Paulo
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Pfizer Investigational Site
City
Munster
Country
Germany
Facility Name
Pfizer Investigational Site
City
Mexico City
ZIP/Postal Code
CP-14370
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Mandaluyong City
ZIP/Postal Code
1550
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Pasig City
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Niao-Sung Hsiang
State/Province
Kaohsiung
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=COXXNT-6570-001&StudyName=Efficacy%20and%20Safety%20of%20Celecoxib%20as%20Add-on%20Therapy%20to%20Risperidone%20Versus%20Risperidone%20Alone%20in%20Patients%20with%20Schizophrenia
Description
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Efficacy and Safety of Celecoxib as Add-on Therapy to Risperidone Versus Risperidone Alone in Patients With Schizophrenia

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