NCT00101634

Brief Summary

The purpose of this study is to determine the efficacy (how well the drug works), safety, and side effects of paliperidone palmitate 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

100
On Track

Trial Health Score

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

Enrollment
518

participants targeted

Target at P75+ for phase_3 schizophrenia

Timeline
Completed

Started Dec 2004

Shorter than P25 for phase_3 schizophrenia

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

December 1, 2004

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

June 8, 2011

Status Verified

January 1, 2011

First QC Date

January 12, 2005

Last Update Submit

June 6, 2011

Conditions

Schizophrenia

Keywords

SchizophreniaPaliperidone palmitateR092670antipsychotic

Outcome Measures

Primary Outcomes (1)

  • Change in total PANSS score from baseline to the end of the double blind treatment period.

Secondary Outcomes (1)

  • PSP and CGI-S scores from baseline to the end of of the double-blind treatment. Incidence of adverse events, labs and ECGs throughout study.

Interventions

Paliperidone palmitateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who meet diagnostic criteria for schizophrenia according to DSM-IV for at least 1 year
  • meet PANSS score criteria
  • have body mass index (BMI) of \>15.0 kilogram(kg)/meter (m)2.

You may not qualify if:

  • Patients who have primary active DSM-IV Axis I diagnosis other than schizophrenia
  • have a decrease of \>/=25% in the PANSS score
  • have history of treatment resistance as defined by failure to respond to 2 adequate trials of different antipsychotic medications
  • have any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)
  • have significant risk of suicidal, homicidal or violent ideation or behavior
  • 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 Links

MeSH Terms

Conditions

Schizophrenia

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

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

January 12, 2005

First Posted

January 13, 2005

Study Start

December 1, 2004

Study Completion

March 1, 2006

Last Updated

June 8, 2011

Record last verified: 2011-01