Safety and Efficacy of an Anti-Psychotic in Patients With Schizophrenia
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of 50 and 100 Mg-eq of Paliperidone Palmitate in Patients With Schizophrenia
1 other identifier
interventional
250
0 countries
N/A
Brief Summary
The purpose of this study is to determine the efficacy (how well the drug works), safety, and side effects of paliperidone palmitate injection compared to placebo in the treatment of the symptoms of schizophrenia in adults. The placebo used in this study was a nutritional substance known as 20% Intralipid emulsion given to patients requiring intravenous feedings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 schizophrenia
Started Oct 2003
Shorter than P25 for phase_2 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
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
December 12, 2003
CompletedFirst Posted
Study publicly available on registry
December 15, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2004
CompletedMay 24, 2011
April 1, 2010
December 12, 2003
May 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change in total PANSS score from the start of the double-blind treatment period to the end of the double-blind treatment period.
Secondary Outcomes (1)
Changes from the start of to the end of the double-blind treatment period in CGI-S and in the PANSS subscales for specific symptoms. Incidence of adverse events, labs and ECGs throughout study.
Interventions
Eligibility Criteria
You may qualify if:
- Patients diagnosed with schizophrenia
- for at least 1 year before screening
- meet PANSS score criteria
- must agree to hospitalization for a minimum of 14 days
- body mass index (BMI) \<35.0 kilogram (kg)/meter (m)2.
You may not qualify if:
- Patients who are involuntarily committed as in-patients
- have a DSM-IV Axis I diagnosis other than schizophrenia
- have a decrease of \>/=25% in the PANSS score between screening and predose
- previous lack of response to 2 adequate trials of antipsychotic treatment
- have a significant risk of suicidal, homicidal, or violent ideation or behavior
- have severe gastrointestinal narrowing (pathologic or iatrogenic)
- current presence of any significant or unstable medication condition
- treatment with any protocol disallowed therapies
- clinically significant result from screening laboratory or ECG.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Kramer M, Litman R, Hough D, Lane R, Lim P, Liu Y, Eerdekens M. Paliperidone palmitate, a potential long-acting treatment for patients with schizophrenia. Results of a randomized, double-blind, placebo-controlled efficacy and safety study. Int J Neuropsychopharmacol. 2010 Jun;13(5):635-47. doi: 10.1017/S1461145709990988. Epub 2009 Nov 27.
PMID: 19941696DERIVED
Related Links
MeSH Terms
Conditions
Condition 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 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 12, 2003
First Posted
December 15, 2003
Study Start
October 1, 2003
Study Completion
July 1, 2004
Last Updated
May 24, 2011
Record last verified: 2010-04