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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00639483
First Posted: March 20, 2008
Last Update Posted: March 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
To assess the efficacy and safety of celecoxib as add-on therapy to risperidone versus risperidone alone in patients with schizophrenia

Condition Intervention Phase
Schizophrenia Drug: Celecoxib Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score [ Time Frame: Week 11 ]

Secondary Outcome Measures:
  • Patient-Reported Outcomes using Treatment Satisfaction Questionnaire for Medication [ Time Frame: Week 4 and 11 ]
  • Physical examination [ Time Frame: Week 11 ]
  • Laboratory exams [ Time Frame: Weeks 1, 2, 4, 6, 8, 11 ]
  • Change from baseline in Global Improvement and Efficacy Index scores of Clinical Global Impressions scale of Psychosis [ Time Frame: Weeks 4, 6, and 11 ]
  • Change from baseline in total PANSS score [ Time Frame: Weeks 4 and 6 ]
  • Change from baseline in PANSS-derived Brief Psychiatric Rating Scale score [ Time Frame: Weeks 4, 6, and 11 ]
  • 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 ]
  • Change from baseline in PANSS five-factor component scores [ Time Frame: Weeks 4, 6, and 11 ]
  • Time to onset of clinically meaningful improvement in total PANSS score [ Time Frame: Weeks 1, 2, 4, 6, 8, and 11 ]
  • Adverse events [ Time Frame: Weeks 1, 2, 4, 6, 8, 11 ]

Enrollment: 270
Study Start Date: March 2003
Study Completion Date: January 2004
Arms Assigned Interventions
Experimental: A Drug: Celecoxib
200 mg oral capsules twice daily as add-on therapy to risperidone twice daily (range 2-8 mg/day) for 11 weeks
Placebo Comparator: B Drug: Placebo
Matched oral placebo as add-on to risperidone twice daily (range 2-8 mg/day) for 11 weeks

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00639483


Locations
Argentina
Pfizer Investigational Site
La Plata, Buenos Aires, Argentina, (1900)
Pfizer Investigational Site
Lanús, Buenos Aires, Argentina, 1824
Pfizer Investigational Site
La Plata, Pcia. de Buenos Aires, Argentina, 1900
Brazil
Pfizer Investigational Site
Salvador, BA, Brazil, 40325-090
Pfizer Investigational Site
PR, Curitiba, Brazil, 80520-000
Pfizer Investigational Site
Aparecida de Goiania, Goiania, Brazil, 74922-810
Pfizer Investigational Site
Rio De Janeiro, Brazil, 21944-970
Pfizer Investigational Site
Sao Paulo, Brazil
Germany
Pfizer Investigational Site
Bonn, Germany, 53105
Pfizer Investigational Site
Muenchen, Germany, 80336
Pfizer Investigational Site
Muenchen, Germany, 81675
Pfizer Investigational Site
Munster, Germany
Mexico
Pfizer Investigational Site
Mexico City, Mexico, CP-14370
Philippines
Pfizer Investigational Site
Mandaluyong City, Philippines, 1550
Pfizer Investigational Site
Pasig City, Philippines
Taiwan
Pfizer Investigational Site
Niao-Sung Hsiang, Kaohsiung, Taiwan
Pfizer Investigational Site
Taipei, Taiwan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00639483     History of Changes
Other Study ID Numbers: COXXNT-6570-001
A3191105
First Submitted: March 13, 2008
First Posted: March 20, 2008
Last Update Posted: March 16, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Celecoxib
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents