Evaluation of Effectiveness and Safety of Paliperidone ER (Extended-release) Compared With Quetiapine in Patients With Schizophrenia

NCT00334126 | Completed Phase 3

• 1 other identifier: CR010501
• Study Type: interventional
• Target: 399
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy (effectiveness of drug) and safety of the antipsychotic paliperidone ER compared to another antipsychotic, quetiapine, and to placebo in patients who are acutely ill with symptoms of schizophrenia.

Conditions

Schizophrenia

Keywords

Schizophrenia; Antipsychotic; paliperidone; quetiapine; Seroquel; placebo

Outcome Measures

Primary Outcomes (1)

• Reduction in total PANSS ( Positive and Negative Syndrome Scale) from baseline to endpoint at Day 14

Secondary Outcomes (1)

• Time to response (based on reduction in PANSS plus Clinical Global Impression - Change) and readiness for discharge, utilization of health care resources and polypharmacy use in patients receiving paliperidone ER or quetiapine

Interventions

paliperidone ER tablets, quetiapine tablets, placebo - all over encapsulated DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnostic and Statistical Manual - Fourth Edition (DSM-IV) diagnosis of schizophrenia (paranoid, disorganized or undifferentiated type)
• score of \>=4 on at least two of a subset of selected PANSS items and a total score on these five items of \>=17
• score of \>=5 on the CGI-S (clinical global impression - severity)
• body weight of at least 60kg and willing to be hospitalized for 9 days initially

You may not qualify if:

• A primary active mental illness diagnosis other than schizophrenia
• subjects whose psychotic symptoms can be explained by substance intake or medical illness
• pregnancy, breast-feeding, or planning to become pregnant
• a history of treatment resistance (defined by failure to respond to 2 adequate trials of different antipsychotic medications or clozapine given at adequate dose for sufficient time)
• unstable or significant medical illness that would increase risk of taking study medication or would confuse the interpretation of the study

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Janssen, LP: collaborator

Related Publications (1)

• Canuso CM, Dirks B, Carothers J, Kosik-Gonzalez C, Bossie CA, Zhu Y, Damaraju CV, Kalali AH, Mahmoud R. Randomized, double-blind, placebo-controlled study of paliperidone extended-release and quetiapine in inpatients with recently exacerbated schizophrenia. Am J Psychiatry. 2009 Jun;166(6):691-701. doi: 10.1176/appi.ajp.2009.08040613. Epub 2009 May 1.

  PMID: 19411369 DERIVED

Related Links

• A randomized, double blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of paliperidone ER compared to quetiapine in subjects with an acute exacerbation schizophrenia

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 2, 2006
• First Posted: June 6, 2006
• Study Start: April 1, 2006
• Study Completion: September 1, 2007
• Last Updated: May 18, 2011

Record last verified: 2010-03