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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00639483

Enrollment

270

Registered

2008-03-20

Start date

2003-03-31

Completion date

2004-01-31

Last updated

2009-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Brief summary

To assess the efficacy and safety of celecoxib as add-on therapy to risperidone versus risperidone alone in patients with schizophrenia

Interventions

DRUGCelecoxib

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score	Week 11

Secondary

Measure	Time frame
Physical examination	Week 11
Laboratory exams	Weeks 1, 2, 4, 6, 8, 11
Change from baseline in Global Improvement and Efficacy Index scores of Clinical Global Impressions scale of Psychosis	Weeks 4, 6, and 11
Change from baseline in total PANSS score	Weeks 4 and 6
Patient-Reported Outcomes using Treatment Satisfaction Questionnaire for Medication	Week 4 and 11
Change from baseline in combined PANSS Negative plus General Psychopathology Subscale Score and the separate PANSS Psychopathology Subscale Scores	Weeks 4, 6, and 11
Change from baseline in PANSS five-factor component scores	Weeks 4, 6, and 11
Time to onset of clinically meaningful improvement in total PANSS score	Weeks 1, 2, 4, 6, 8, and 11
Adverse events	Weeks 1, 2, 4, 6, 8, 11
Change from baseline in PANSS-derived Brief Psychiatric Rating Scale score	Weeks 4, 6, and 11

Countries

Argentina, Brazil, Germany, Mexico, Philippines, Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026