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SchizophreniaPhase 1NCT00796081

A Safety and Pharmacokinetic Study of ER OROS Paliperidone in Pediatric Patients With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder

A Phase 1 study testing ER OROS paliperidone, paliperidone ER in people with Schizophrenia and Schizoaffective Disorder, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purposes of this study are to characterize the pharmacokinetics of paliperidone after single- and multiple-dose administration of paliperidone ER in children and adolescent patients (>= 10 to <= 17 years of age) with schizophrenia, schizoaffective disorder, or schizophreniform disorder and to evaluate the safety… Read more about this study

Who is it for?
Ages 10 to 17 years
What is being tested?
ER OROS paliperidone, paliperidone ER
How many people
25 participants
Where
No sites listed yet
Study dates
Jan 2006to Aug 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 10 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Patients' height and weight must be within the 5th to 95th Physical Growth National Center for Health Statistics percentiles for age and sex
  • Patients must have a diagnosis of schizophrenia of any subtype (295.10
  • 295.20
  • 295.30
  • 295.60
  • 295.90), schizoaffective disorder (295.70), or schizophreniform disorder (295.40), according to the DSM-IV-TR
Show all 11Show fewer
  • Patients must be healthy (other than the DSM-IV-TR classification), on the basis of the screening medical history, physical examination, 12-lead ECG, and clinical laboratory tests (hematology, serum chemistry, and urinalysis). Patients with laboratory results outside the normal reference range can be included only if the investigator, upon consultation with the sponsor, judges the deviations as not clinically significant
  • QT values must be within normal limits and patients must have a CGI-S score of less than or equal to 3
  • Female patients must be premenarchal, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) for at least 1 month before study entry and throughout the study, have a negative serum beta-human chorionic gonadotropin pregnancy test at screening, and a negative urine pregnancy test on Day 1
  • Patients must sign an informed assent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study, with Parent(s) or the legal guardian(s) of each patient signing an informed consent document indicating that they understand the purpose of and the procedures required for the study and give permission for their child's participation in the study and a responsible person must be available to accompany the patient to the investigational site at each visit
  • Patients must agree to be hospitalized at any time during the study, and their parent(s) or legal guardian(s) must consent, if it is deemed clinically necessary by the investigator.

Who cannot join

  • Patients with an active DSM-IV-TR axis I diagnosis other than schizophrenia, schizoaffective disorder, or schizophreniform disorder
  • Patients with a history of DSM-IV-TR diagnosis of substance dependence within 6 months before screening (nicotine and caffeine dependence are not exclusionary) or patients who are involuntarily committed to psychiatric hospitalization
  • Patients with a significant risk of suicidal or violent ideation or behavior, as judged by the clinical investigator
  • Female patients who are pregnant, who plan to become pregnant during the study, or who are breast-feeding
  • Patients with any medical condition that can potentially alter the absorption, metabolism, or excretion of the study drug (e.g., Crohn's disease, severe gastrointestinal narrowing [pathologic or iatrogenic], liver disease, or renal disease)
  • Patients with a history of any malignancy, with the exception of basal cell carcinoma, in the past 5 years
  • Patients with a history of a positive result for any serology test (e.g., human immunodeficiency virus, hepatitis), with a history of neuroleptic malignant syndrome

About this study

Official title: Open-label Study to Evaluate the Safety and Pharmacokinetics of Single- and Multiple-dose Extended-release OROS Paliperidone in Pediatric Subjects (=10 to =17 Years of Age) With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder

The purposes of this study are to characterize the pharmacokinetics of paliperidone after single- and multiple-dose administration of paliperidone ER in children and adolescent patients (>= 10 to <= 17 years of age) with schizophrenia, schizoaffective disorder, or schizophreniform disorder and to evaluate the safety and tolerability of paliperidone ER in this patient population.

Read the detailed description

The current study is designed as a multicenter, open-label, multiple-dose study in children and adolescent patients >= 10 to <= 17 years of age with schizophrenia, schizoaffective disorder, or schizophreniform disorder. The study includes 3 dosage groups (0.086, 0.129, and 0.171 mg/kg/day paliperidone ER), which will be studied in a sequential ascending design, so that the safety of the drug can be properly evaluated with a lower dosage before proceeding to the next higher dosage. The 3 dosages are approximately 6, 9, and 12 mg/day in adults. Within each dosage group, patients will be randomly assigned to 1 of 2 pharmacokinetic sampling schedules in a 1:1 ratio. For each dosage group, the study consists of a screening phase (for a maximum of 21 days); a 2-day, single-dose pharmacokinetic and tolerability evaluation phase; a 7-day multiple-dose phase, with evaluation of pharmacokinetics and tolerability; and an end-of-study visit. Following the completion of all patients in a given dosage group, the sponsor will evaluate the safety and tolerability of the treatment, in order to determine whether to proceed to the next higher or lower dosage level. The first group will start at 0.086 mg/kg/day. The hypothesis is that paliperidone ER will be well tolerated in children and adolescent patients with schizophrenia, schizoaffective disorder, or schizophreniform disorder, and will display the expected pharmacokinetic characteristics in this population. Paliperidone ER 0.086, 0.129, and 0.171 mg/kg/day, oral administration, single dose on Day 1 of study followed by once daily dosing on Days 3 to 9.

Being tested
ER OROS paliperidone, paliperidone ER
Keywords
Schizophrenia, Schizoaffective disorder, Schizophreniform disorders, Mood disorders, Antipshychotic drugs, Pediatrics, ER OROS Paliperidone, Paliperidone ER
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.

  • ER OROS paliperidone, paliperidone ERDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. to characterize the pharmacokinetics of paliperidone after single- and multiple-dose oral administrations of paliperidone ER in children and adolescent patients (>= 10 to <= 17 years of age)

Secondary outcomes (1)

  1. to evaluate the safety and tolerability of paliperidone ER in this patient population

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2008 (estimated)
  2. Study startJan 2006
  3. Study completionAug 2006

Resources

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
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00796081
Sponsor's protocol ID
CR002371
Status last verified
Mar 2010
First submitted
20 Nov 2008
Last updated
8 Jun 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ER OROS paliperidone, 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 11 inclusion and 7 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 8 Jun 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 characterize the pharmacokinetics of paliperidone after single- and multiple-dose oral administrations of paliperidone ER in children and adolescent patients (>= 10 to <= 17 years of age). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00796081.

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 8 Jun 2011.

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