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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00639483
First received: March 13, 2008
Last updated: March 12, 2009
Last verified: March 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient-Reported Outcomes using Treatment Satisfaction Questionnaire for Medication [ Time Frame: Week 4 and 11 ] [ Designated as safety issue: No ]
  • Physical examination [ Time Frame: Week 11 ] [ Designated as safety issue: Yes ]
  • Laboratory exams [ Time Frame: Weeks 1, 2, 4, 6, 8, 11 ] [ Designated as safety issue: Yes ]
  • Change from baseline in Global Improvement and Efficacy Index scores of Clinical Global Impressions scale of Psychosis [ Time Frame: Weeks 4, 6, and 11 ] [ Designated as safety issue: No ]
  • Change from baseline in total PANSS score [ Time Frame: Weeks 4 and 6 ] [ Designated as safety issue: No ]
  • Change from baseline in PANSS-derived Brief Psychiatric Rating Scale score [ Time Frame: Weeks 4, 6, and 11 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline in PANSS five-factor component scores [ Time Frame: Weeks 4, 6, and 11 ] [ Designated as safety issue: No ]
  • Time to onset of clinically meaningful improvement in total PANSS score [ Time Frame: Weeks 1, 2, 4, 6, 8, and 11 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Weeks 1, 2, 4, 6, 8, 11 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00639483     History of Changes
Other Study ID Numbers: COXXNT-6570-001, A3191105
Study First Received: March 13, 2008
Last Updated: March 12, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Celecoxib
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on July 23, 2014