SchizophreniaPhase 1NCT00791622
A Study of QT and QTc Intervals in Patients Administered Extended Release Paliperidone or Quetiapine
A Phase 1 study testing Paliperidone ER in people with Schizophrenia and Schizoaffective Disorder, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Paliperidone ER
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Jun 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating QT/QTc Intervals Following Administration of Extended-release Paliperidone and Quetiapine in Subjects With Schizophrenia or Schizoaffective Disorder
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.
Read the 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 of open-label moxifloxacin treatment (Day 1), 10 days of double-blind treatment (Days 2 to 11), and end of study evaluations (Day 12). On Day 1, all patients will receive open-label treatment with a single dose of 400 mg moxifloxacin administered in the morning. Moxifloxacin will be used to establish assay sensitivity on the QTc interval. Patients will then be randomly assigned to receive double-blind treatment with placebo, paliperidone ER, or quetiapine on Days 2 to 11. Two doses of paliperidone ER will be studied: 12 mg/day that is the maximum recommended dose and 18 mg/day that is a supratherapeutic dose (50% above the maximum recommended). Patients randomly assigned to paliperidone ER will be administered 12 mg on Days 2 to 6, 15 mg on Day 7, and 18 mg on Days 8 to 11. Patients randomly assigned to quetiapine will receive 100 mg bid on Day 2, 200 mg twice daily (bid) on Day 3, 300 mg bid on Day 4, and 400 mg bid on Days 5 to 11. Patients will receive double-blind study drug 30 minutes after having a standardized breakfast on Days 2 to 11. Serial time matched 12 lead ECG triplicate readings will be recorded on Days -2, -1, 6, and 11 (predose and 1, 1.5, 2.5, 3.5, 4.5, 6, and 12 hours postdose) as well as Day 1 (predose, 1, 1.5, 2.5, 3.5 hours postdose) and Days 7 and 12 (23.5 hours postdose). This study will explore the QTc and pharmacokinetic data from paliperidone ER (commercial formulation) and quetiapine (marketed atypical antipsychotic of the same therapeutic class) at the maximum recommended doses for both products and at a supratherapeutic dose (50% above the maximum proposed labeled dose) for paliperidone ER. Safety and tolerability will be monitored throughout the study.
A single oral dose of moxifloxacin 400 mg tablet on Day 1; Oral paliperidone ER 12 mg on Days 2 to 6; 15 mg on Day 7, and 18 mg on Days 8 to 11; Oral quetiapine 100 mg twice daily (bid) on Day 2; 200 mg bid on Day 3; 300 mg bid on Day 4; and 400 mg bid on Days 5 to 11.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Paliperidone ER
- Keywords
- Paliperidone ER, Schizophernia, Mood Disorders, Antipsychotic drugs, Cardiovascular, Schizoaffective Disorder
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paliperidone ERDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startJan 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791622
- Sponsor's protocol ID
- CR011056
- Status last verified
- Apr 2010
- First submitted
- 13 Nov 2008
- Last updated
- 18 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating QT/QTc Intervals Following Administration of Extended-release Paliperidone and Quetiapine in Subjects With Schizophrenia or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT00791622
- Acronym / sponsor ID
- CR011056
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Paliperidone ER, Schizophernia, Mood Disorders, Antipsychotic drugs, Cardiovascular, Schizoaffective Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Jan 2006
- Study completion
- Jun 2006 (actual)
- First posted
- 14 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 of open-label moxifloxacin treatment (Day 1), 10 days of double-blind treatment (Days 2 to 11), and end of study evaluations (Day 12). On Day 1, all patients will receive open-label treatment with a single dose of 400 mg moxifloxacin administered in the morning. Moxifloxacin will be used to establish assay sensitivity on the QTc interval. Patients will then be randomly assigned to receive double-blind treatment with placebo, paliperidone ER, or quetiapine on Days 2 to 11. Two doses of paliperidone ER will be studied: 12 mg/day that is the maximum recommended dose and 18 mg/day that is a supratherapeutic dose (50% above the maximum recommended). Patients randomly assigned to paliperidone ER will be administered 12 mg on Days 2 to 6, 15 mg on Day 7, and 18 mg on Days 8 to 11. Patients randomly assigned to quetiapine will receive 100 mg bid on Day 2, 200 mg twice daily (bid) on Day 3, 300 mg bid on Day 4, and 400 mg bid on Days 5 to 11. Patients will receive double-blind study drug 30 minutes after having a standardized breakfast on Days 2 to 11. Serial time matched 12 lead ECG triplicate readings will be recorded on Days -2, -1, 6, and 11 (predose and 1, 1.5, 2.5, 3.5, 4.5, 6, and 12 hours postdose) as well as Day 1 (predose, 1, 1.5, 2.5, 3.5 hours postdose) and Days 7 and 12 (23.5 hours postdose). This study will explore the QTc and pharmacokinetic data from paliperidone ER (commercial formulation) and quetiapine (marketed atypical antipsychotic of the same therapeutic class) at the maximum recommended doses for both products and at a supratherapeutic dose (50% above the maximum proposed labeled dose) for paliperidone ER. Safety and tolerability will be monitored throughout the study.
A single oral dose of moxifloxacin 400 mg tablet on Day 1; Oral paliperidone ER 12 mg on Days 2 to 6; 15 mg on Day 7, and 18 mg on Days 8 to 11; Oral quetiapine 100 mg twice daily (bid) on Day 2; 200 mg bid on Day 3; 300 mg bid on Day 4; and 400 mg bid on Days 5 to 11.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paliperidone ER | Drug | – |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2011.
- A study of QT and QTc intervals in patients administered extended release paliperidone or quetiapineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Paliperidone ER in people with Schizophrenia and Schizoaffective Disorder, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2011.