A Study to Evaluate the Effectiveness and Safety of 3 Doses of Paliperidone Palmitate in Treating Subjects With Schizophrenia
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Response Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (50 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Subjects With Schizophrenia
1 other identifier
interventional
366
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of 3 doses of paliperidone palmitate in treating subjects with schizophrenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 schizophrenia
Started Apr 2005
Shorter than P25 for phase_3 schizophrenia
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedJune 8, 2011
April 1, 2010
September 13, 2005
June 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change in the total score of the Positive and Negative Syndrome Scale for Schizophrenia (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
Eligibility Criteria
You may qualify if:
- A DSM-IV diagnosis of schizophrenia (disorganized, catatonic, paranoid, residual, or undifferentiated type) for at least 1 year before the screening evaluation
- a total PANSS score of 70 to 120 at screening and baseline (pre-treatment) evaluations
- a body mass index (BMI \[weight (kilograms)\]/\[height (meters)\]²) of more than 17.0 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Gopal S, Hough DW, Xu H, Lull JM, Gassmann-Mayer C, Remmerie BM, Eerdekens MH, Brown DW. Efficacy and safety of paliperidone palmitate in adult patients with acutely symptomatic schizophrenia: a randomized, double-blind, placebo-controlled, dose-response study. Int Clin Psychopharmacol. 2010 Sep;25(5):247-56. doi: 10.1097/YIC.0b013e32833948fa.
PMID: 20389255DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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
April 1, 2005
Study Completion
June 1, 2006
Last Updated
June 8, 2011
Record last verified: 2010-04