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OpenTrials
Completed

NCT Number: NCT00639483

Efficacy and Safety 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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, La Plata, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celecoxib

Drug

200 mg oral capsules twice daily as add-on therapy to risperidone twice daily (range 2-8 mg/day) for 11 weeks

Placebo

Drug

Matched oral placebo as add-on to risperidone twice daily (range 2-8 mg/day) for 11 weeks

Primary outcomes

  1. Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score

    Time frame: Week 11

Secondary outcomes

  1. Patient-Reported Outcomes using Treatment Satisfaction Questionnaire for Medication

    Time frame: Week 4 and 11

  2. Physical examination

    Time frame: Week 11

  3. Laboratory exams

    Time frame: Weeks 1, 2, 4, 6, 8, 11

  4. Change from baseline in Global Improvement and Efficacy Index scores of Clinical Global Impressions scale of Psychosis

    Time frame: Weeks 4, 6, and 11

  5. Change from baseline in total PANSS score

    Time frame: Weeks 4 and 6

  6. Change from baseline in PANSS-derived Brief Psychiatric Rating Scale score

    Time frame: Weeks 4, 6, and 11

  7. 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

  8. Change from baseline in PANSS five-factor component scores

    Time frame: Weeks 4, 6, and 11

  9. Time to onset of clinically meaningful improvement in total PANSS score

    Time frame: Weeks 1, 2, 4, 6, 8, and 11

  10. Adverse events

    Time frame: Weeks 1, 2, 4, 6, 8, 11

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2004
First posted
Mar 20, 2008
Registry last updated
Mar 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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