NCT00639483

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for phase_2 schizophrenia

Timeline
Completed

Started Mar 2003

Shorter than P25 for phase_2 schizophrenia

Geographic Reach
6 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2008

Completed
Last Updated

March 16, 2009

Status Verified

March 1, 2009

First QC Date

March 13, 2008

Last Update Submit

March 12, 2009

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

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

    Week 11

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL
Drug: Celecoxib

B

PLACEBO COMPARATOR
Drug: Placebo

Interventions

CelecoxibDRUG

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

A
PlaceboDRUG

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

B

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Pfizer Investigational Site

La Plata, Buenos Aires, (1900), Argentina

Location

Pfizer Investigational Site

Lanús, Buenos Aires, 1824, Argentina

Location

Pfizer Investigational Site

La Plata, Pcia. de Buenos Aires, 1900, Argentina

Location

Pfizer Investigational Site

PR, Curitiba, 80520-000, Brazil

Location

Pfizer Investigational Site

Salvador, Estado de Bahia, 40325-090, Brazil

Location

Pfizer Investigational Site

Aparecida de Goiânia, Goiania, 74922-810, Brazil

Location

Pfizer Investigational Site

Rio de Janeiro, Rio de Janeiro, 21944-970, Brazil

Location

Pfizer Investigational Site

São Paulo, São Paulo, Brazil

Location

Pfizer Investigational Site

Bonn, 53105, Germany

Location

Pfizer Investigational Site

München, 80336, Germany

Location

Pfizer Investigational Site

München, 81675, Germany

Location

Pfizer Investigational Site

Münster, Germany

Location

Pfizer Investigational Site

Mexico City, CP-14370, Mexico

Location

Pfizer Investigational Site

Mandaluyong, 1550, Philippines

Location

Pfizer Investigational Site

Pasig, Philippines

Location

Pfizer Investigational Site

Niao-Sung Hsiang, Kaohsiung, Taiwan

Location

Pfizer Investigational Site

Taipei, Taiwan

Location

Related Links

MeSH Terms

Conditions

Schizophrenia

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 13, 2008

First Posted

March 20, 2008

Study Start

March 1, 2003

Study Completion

January 1, 2004

Last Updated

March 16, 2009

Record last verified: 2009-03

Locations

AR(3)DE(4)BR(5)ME(1)PH(2)TW(2)