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

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NCT00639483

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Study Location
Pfizer Investigational Site
La Plata, Buenos Aires, (1900), Argentina
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
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  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Arms  ICMJE
  • 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
Actual Enrollment  ICMJE
 (submitted: March 13, 2008)		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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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