A Study to Compare the Effectiveness and Safety of Flexibly Varied Doses of Paliperidone Palmitate and Risperidone in Treating Patients With Schizophrenia

NCT00210717 | Completed Phase 3

• 1 other identifier: CR004195
• Study Type: interventional
• Target: 748
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the effectiveness and safety over 1 year of treatment of intramuscular injections of paliperidone palmitate and long-acting risperidone in patients with schizophrenia.

Conditions

Schizophrenia

Keywords

schizophrenia; intramuscular injection; antipsychotic agents; risperidone; paliperidone palmitate; dementia praecox; mental disorders; PANSS

Outcome Measures

Primary Outcomes (1)

• The change in the total score of the Positive and Negative Syndrome Scale (PANSS) from the beginning to the end of the double-blind treatment period or to the last post-randomization assessment.

Secondary Outcomes (1)

• The investigator's Clinical Global Impression of the Severity (CGI-S) of schizophrenia and rating of mental function on a Personal and Social Performance Scale (PSP). Evaluations of adverse events, laboratory tests, and other measures of drug safety.

Interventions

paliperidone palmitate DRUG

Eligibility Criteria

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

You may qualify if:

• A diagnosis of schizophrenia (disorganized, catatonic, paranoid, residual, or undifferentiated types) according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) for at least 1 year before the screening evaluation
• a total PANSS score of 60 to 120 at screening and baseline (pre-treatment) evaluations
• a body mass index (BMI \[weight (kilograms)\]/\[height (meters)\]²) of at least 15.0 kg/m² .

You may not qualify if:

• A primary active DSM-IV Axis I diagnosis other than schizophrenia
• a decrease of 25% or more in the total PANSS score between screening and baseline evaluations
• a DSM-IV diagnosis of active substance dependence within 3 months of screening evaluation
• a history of treatment resistance as defined by failure to respond to 2 adequate trials of different antipsychotic medications
• a woman who is pregnant, breast-feeding, or planning to become pregnant during the study period.

Sponsors & Collaborators

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

Related Publications (1)

• Fleischhacker WW, Gopal S, Lane R, Gassmann-Mayer C, Lim P, Hough D, Remmerie B, Eerdekens M. A randomized trial of paliperidone palmitate and risperidone long-acting injectable in schizophrenia. Int J Neuropsychopharmacol. 2012 Feb;15(1):107-18. doi: 10.1017/S1461145711001076. Epub 2011 Jul 22.

  PMID: 21777507 DERIVED

Related Links

• A study to compare the efficacy and safety of flexibly varied doses of paliperidone palmitate and risperidone in treating patients with schizophrenia

MeSH Terms

Conditions

Schizophrenia; Mental Disorders

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

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: September 13, 2005
• First Posted: September 21, 2005
• Study Start: February 1, 2005
• Study Completion: April 1, 2007
• Last Updated: June 8, 2011

Record last verified: 2010-04