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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
La Plata, Buenos Aires, (1900) Argentina
Contact
1-800-718-1021
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

NCT00639483
Pfizer
Completed
Efficacy and Safety of Celecoxib as Add-on Therapy to Risperidone Versus Risperidone Alone in Patients With Schizophrenia

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Efficacy and Safety of Celecoxib as Add-on Therapy to Risperidone Versus Risperidone Alone in Patients With Schizophrenia
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
To assess the efficacy and safety of celecoxib as add-on therapy to risperidone versus risperidone alone in patients with schizophrenia
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • 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
  • Experimental: A
    Intervention: Drug: Celecoxib
  • Placebo Comparator: B
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
270
January 2004
Not Provided

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   Germany,   Mexico,   Philippines,   Taiwan
 
 
NCT00639483
COXXNT-6570-001
A3191105
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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