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

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

Official Title
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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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Celecoxib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: Celecoxib<br>* 200 mg oral capsules twice daily as add-on therapy to risperidone twice daily (range 2-8 mg/day) for 11 weeks<br>|
| Placebo Comparator: B<br> | Drug: Placebo<br>* Matched oral placebo as add-on to risperidone twice daily (range 2-8 mg/day) for 11 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score |  | Week 11 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Reported Outcomes using Treatment Satisfaction Questionnaire for Medication |  | Week 4 and 11 | 
| 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 | 
| Change from baseline in PANSS-derived Brief Psychiatric Rating Scale score |  | Weeks 4, 6, 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 |