Clinical trial NCT00639483: Efficacy and Safety of Celecoxib as Add-on Therapy to Risperidone Versus Risperidone Alone in Patients With Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-20
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score
timeFrame: Week 11
Secondary outcomes:
measure: Patient-Reported Outcomes using Treatment Satisfaction Questionnaire for Medication
timeFrame: Week 4 and 11
measure: Physical examination
timeFrame: Week 11
measure: Laboratory exams
timeFrame: Weeks 1, 2, 4, 6, 8, 11
measure: Change from baseline in Global Improvement and Efficacy Index scores of Clinical Global Impressions scale of Psychosis
timeFrame: Weeks 4, 6, and 11
measure: Change from baseline in total PANSS score
timeFrame: Weeks 4 and 6
measure: Change from baseline in PANSS-derived Brief Psychiatric Rating Scale score
timeFrame: Weeks 4, 6, and 11
measure: Change from baseline in combined PANSS Negative plus General Psychopathology Subscale Score and the separate PANSS Psychopathology Subscale Scores
timeFrame: Weeks 4, 6, and 11
measure: Change from baseline in PANSS five-factor component scores
timeFrame: Weeks 4, 6, and 11
measure: Time to onset of clinically meaningful improvement in total PANSS score
timeFrame: Weeks 1, 2, 4, 6, 8, and 11
measure: Adverse events
timeFrame: Weeks 1, 2, 4, 6, 8, 11
Other outcomes:
Locations:
city: La Plata
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Lanús
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: La Plata
country: Argentina
facility: Pfizer Investigational Site
state: Pcia. de Buenos Aires
city: Salvador
country: Brazil
facility: Pfizer Investigational Site
state: BA
city: PR
country: Brazil
facility: Pfizer Investigational Site
state: Curitiba
city: Aparecida de Goiania
country: Brazil
facility: Pfizer Investigational Site
state: Goiania
city: Rio De Janeiro
country: Brazil
facility: Pfizer Investigational Site
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
city: Bonn
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Munster
country: Germany
facility: Pfizer Investigational Site
city: Mexico City
country: Mexico
facility: Pfizer Investigational Site
city: Mandaluyong City
country: Philippines
facility: Pfizer Investigational Site
city: Pasig City
country: Philippines
facility: Pfizer Investigational Site
city: Niao-Sung Hsiang
country: Taiwan
facility: Pfizer Investigational Site
state: Kaohsiung
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: