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

Back to Search
Print
Bookmark Trial

NCT00639483

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
La Plata, Buenos Aires, (1900), Argentina
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now
pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
Learn more ›

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

SchizophreniaAdd On Treatment for Cognitive Deficits in Schizophrenia
NCT01346163
  1. Philadelphia, Pennsylvania
ALL GENDERS
18 Years+
years
MULTIPLE SITES
SchizophreniaThe Efficacy And Safety Of Intramuscular Ziprasidone For Three Days In Patients With Psychotic Agitation
NCT02935998
  1. Beijing, Beijing
ALL GENDERS
18 Years+
years
MULTIPLE SITES
SchizophreniaZiprasidone for Clozapine- or Olanzapine-Associated Diabetes Mellitus
NCT00351000
  1. Boston, Massachusetts
ALL GENDERS
18 Years+
years
MULTIPLE SITES
SchizophreniaEffects of Varenicline on Plasticity in Schizophrenia
NCT01934023
  1. Toronto, Ontario
ALL GENDERS
18 Years+
years
MULTIPLE SITES
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