A Study of QT and QTc Intervals in Patients Administered Extended Release Paliperidone or Quetiapine

NCT00791622 | Completed Phase 1

• 1 other identifier: CR011056
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to 1) determine whether the effect on QT interval corrected (QTcLD) for heart rate using the population specified linear derived method at steady state is comparable between 12 mg paliperidone extended-release (ER) once daily and that of 400-mg quetiapine administered twice daily, 2) to explore the relationship between the pharmacokinetics of paliperidone ER and electrocardiogram (ECG) parameters of interest, 3) to explore the cardiovascular safety and tolerability of 18 mg paliperidone ER at steady state, and 4) to evaluate the safety and tolerability of all treatments.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Paliperidone ER; Schizophernia; Mood Disorders, Antipsychotic drugs; Cardiovascular; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

• To determine whether the effect on QTcLD is comparable between 12-mg paliperidone ER at steady state and that of 400-mg quetiapine at steady state with twice daily dose administration.

Secondary Outcomes (1)

• To explore the relationship between the pharmacokinetics of paliperidone ER and ECG parameters of interest, to evaluate the cardiovascular safety and tolerability of 18-mg paliperidone ER at steady state, and to evaluate overall safety and tolerability

Interventions

Paliperidone ER DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of schizophrenia or schizoaffective disorder as defined by DSM-IV-TR criteria, with stable symptoms. Symptom stability is based on the clinical judgment of the investigator but should include as a minimum: no exacerbation of psychotic symptoms or psychiatric hospitalization for at least 3 months before screening and a CGI-S score of \< =4 (moderate) at screening and Day -1
• Must have a normal 12-lead ECG at screening and on Days -1 and -2, including: Normal sinus rhythm (heart rate between 50 and 100 beats per minute
• QTcB interval \< = 430 milliseconds for men, \< = 450 milliseconds for women
• QRS interval \< 110 milliseconds
• PR interval \< 200 milliseconds
• Must weigh \> = 50 kg ( \> = 110 lb), with a BMI \> = 18 and \< = 35 kg/m2
• If female, must be postmenopausal for at least 2 years, surgically sterile, abstinent, or agree to practice an effective method of birth control if they are sexually active before entry and throughout the study. Effective methods of birth control include: abstinence, prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, and male partner sterilization. Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline before receiving a dose of study drug

You may not qualify if:

• Meets DSM-IV criteria for substance dependence in the 3 months before screening
• Is at risk for suicidal or violent behavior, as judged by the investigator
• Has a clinically significant abnormality on ECG at screening or on Days 2 and -1 of the study
• Has a heart rhythm disturbance that is known or suggested by history or that is demonstrated on ECG at screening, or on Days -2 and -1 of the study
• Has a blood pressure outside of the normal range (supine systolic blood pressure \< 90 or \> 140 mmHg or diastolic blood pressure \< 60 or \> 90 mmHg)
• 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
• Has a history of additional risk factors for torsade de pointes, such as heart failure, hypokalemia, family history of known short or long QT syndrome, or sudden unexplained death at a young age (\< = 40 years) in a first-degree relative (i.e., biological parent, sibling, or offspring)
• 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, hematologic, or other systemic disease

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Links

• A study of QT and QTc intervals in patients administered extended release paliperidone or quetiapine

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Mood Disorders

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Johnson & Johnson Pharmaceutical Research and 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: January 1, 2006
• Study Completion: June 1, 2006
• Last Updated: May 18, 2011

Record last verified: 2010-04