NCT00791349

Brief Summary

The purpose of this study is to assess the cardiovascular safety of paliperidone in patients with schizophrenia or schizoaffective disorder, with particular attention to the length of the QT/QTc interval, to measure and review other electrocardiogram (ECG) parameters, such as QRS and PR intervals, to explore the relationship between the pharmacokinetics of paliperidone and ECG parameters of interest, and to explore the safety and tolerability of paliperidone

Trial Health

100
On Track

Trial Health Score

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

Enrollment
141

participants targeted

Target at P75+ for phase_1 schizophrenia

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_1 schizophrenia

Status
completed

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

February 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2008

Completed
Last Updated

June 8, 2011

Status Verified

March 1, 2010

First QC Date

November 13, 2008

Last Update Submit

June 6, 2011

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

SchizophreniaSchizoaffective DisorderMood DisordersAntipsychotic drugsCardiovascularImmediate release (IR) Paliperidone

Outcome Measures

Primary Outcomes (1)

  • To assess the cardiovascular safety of paliperidone in schizophrenic or schizoaffective patients, with particular attention to the length of the QT/QTc interval. Other ECG parameters, such as QRS and PR intervals, will also be carefully measured

Secondary Outcomes (1)

  • To explore the relationship between the pharmacokinetics of paliperidone and ECG parameters of interest, and to explore the safety and tolerability of paliperidone

Interventions

Immediate release (IR) PaliperidoneDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients must have a diagnosis of schizophrenia or schizoaffective disorder as defined by DSM-IV criteria, with no exacerbation of psychosis for at least 3 months prior to screening
  • Patients must have a normal 12-lead ECG at screening and on Day -1, including: Normal sinus rhythm (heart rate between 50 and 100 beats per minute)
  • QTcB interval \< = 430 msec for men, \< = 450 msec for women
  • QRS interval \<110 msec, PR interval \< 200 msec
  • Patients must weigh \> = 50 kg ( \> = 110 lb), with a body mass index \> = 18 and \< = 35 kg/m2
  • Female patients must be postmenopausal (for at least 1 year), surgically sterile, or practicing an effective non-hormonal method of birth control (e.g., intrauterine device, double-barrier method, male partner sterilization, abstinence) before entry and throughout the study
  • must have a negative serum beta human chorionic gonadotropin pregnancy test at screening
  • and must have a negative urine pregnancy test within 24 hours before Day 1 of the randomization period.

You may not qualify if:

  • Patient meets DSM-IV criteria for psychoactive substance dependence in the 3 months prior to screening
  • Patient is at risk for suicidal or violent behavior, as judged by the investigator: Patient has a clinically significant abnormality on ECG at screening or on Day -1 of the study
  • Patient has a heart rhythm disturbance that is known or suggested by history or that is demonstrated on ECG at screening
  • Patient has a blood pressure outside of the normal range (supine systolic blood pressure \<90 or \>140 mmHg and/or diastolic blood pressure \<60 or \> 90 mmHg)
  • Patient has unusual T-wave morphology in a majority of leads of the ECG (such as bifid T waves, low T waves) or prominent U waves at screening: Patient has a history of additional risk factors for torsade de pointes, such as heart failure, hypokalemia, family history of known long QT interval syndrome, or sudden unexplained death at a young age ( \< = 40 years) in a first-degree relative (i.e., biological parent, sibling, or offspring)
  • Patient has a relevant history of any significant and/or unstable cardiovascular, respiratory (including bronchial asthma), neurologic (including seizures or significant cerebrovascular disease), renal, hepatic, endocrine, immunologic, ophthalmologic, hematological, or other systemic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersMood Disorders

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 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 13, 2008

First Posted

November 14, 2008

Study Start

February 1, 2005

Study Completion

May 1, 2005

Last Updated

June 8, 2011

Record last verified: 2010-03