Status:
COMPLETED
A Study of QT and QTc Intervals in Patients Administered Extended Release Paliperidone or Quetiapine
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 betwe...
Detailed Description
This multicenter, placebo- and positive-controlled, randomized study consists of 3 phases - a screening phase of up to 5 days, a 6-day placebo washout phase, and a treatment phase that includes 1-day ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00791622
Start Date
January 1 2006
End Date
June 1 2006
Last Update
May 18 2011
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