NCT00119756

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of intramuscular injections (to the buttocks or to the shoulders) of paliperidone palmitate in patients with schizophrenia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
253

participants targeted

Target at P25-P50 for phase_3 schizophrenia

Timeline
Completed

Started Jun 2005

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

June 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 7, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 14, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

June 8, 2011

Status Verified

April 1, 2010

First QC Date

July 7, 2005

Last Update Submit

June 6, 2011

Conditions

Schizophrenia

Keywords

SchizophreniaIntramuscular injectionDeltoid muscleGluteus musclePaliperidone palmitate

Outcome Measures

Primary Outcomes (1)

  • Safety evaluation (e.g. incidence of adverse events) between start and finish of the trial

Secondary Outcomes (1)

  • Pharmacokinetic evaluations (e.g. blood level of the drug) at finish of trial; Efficacy measures at finish of trial

Interventions

paliperidone palmitateDRUG

Eligibility Criteria

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

You may qualify if:

  • The patient must have signed an informed consent
  • The patient must meet the diagnostic criteria for schizophrenia
  • Female patient must be postmenopausal for at least 2 years or have negative pregnancy test result at screening
  • The patient must be able to perform study requirements (e.g. answer questionnaire)

You may not qualify if:

  • Primary, active diagnosis other than schizophrenia
  • Psychiatric inpatient hospitalization for relapse of symptoms of schizophrenia in the past 90 days
  • Change in their antipsychotic medication in the past 45 days
  • Diagnosis of active substance dependence within 3 months
  • History of treatment resistance
  • History of concurrent significant or unstable diseases (e.g. heart, lung, or liver diseases)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hough D, Lindenmayer JP, Gopal S, Melkote R, Lim P, Herben V, Yuen E, Eerdekens M. Safety and tolerability of deltoid and gluteal injections of paliperidone palmitate in schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2009 Aug 31;33(6):1022-31. doi: 10.1016/j.pnpbp.2009.05.014. Epub 2009 May 28.

    PMID: 19481579DERIVED

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
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 7, 2005

First Posted

July 14, 2005

Study Start

June 1, 2005

Study Completion

November 1, 2006

Last Updated

June 8, 2011

Record last verified: 2010-04