Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00518323
Status:
COMPLETED
Last Update Posted:
2014-04-16
First Post:
2007-08-16
Brief Title:
A Double-blind Placebo-controlled Study of the Safety and Efficacy of Paliperidone Extended Release ER in the Treatment of Schizophrenia in Adolescent Patients
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Multicenter Double-Blind Weight-Based Fixed-Dose Parallel-Group Placebo-Controlled Study of the Efficacy and Safety of Extended Release Paliperidone for the Treatment of Schizophrenia in Adolescent Subjects 12 to 17 Years of Age
Status:
COMPLETED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy safety and tolerability of 3 weight-based fixed-dose groups of paliperidone extended release ER compared with placebo in adolescent patients between 12 to 17 years of age who are diagnosed with schizophrenia Paliperidone ER is an atypical antipsychotic agent approved by the US Food and Drug Administration for the treatment of schizophrenia in adults Patients may be voluntary inpatients or outpatients at the time of the screening visit but should have returned to their usual living situation by Day 21 of the double-blind treatment phase The study duration is approximately 10 weeks Patients who have completed this study or who were discontinued from this study due to lack of efficacy but have completed at least 21 days of double-blind treatment and are expected to benefit from paliperidone treatment may enter an optional open-label safety study
Detailed Description:
The study is a multicenter randomized treatment group is assigned by chance double-blind neither the physician nor the patient knows which treatment group the patient is in parallel-group placebo controlled study This study will enroll adolescent men and women who have schizophrenia as specified by the Diagnostic and Statistical Manual of Mental Disorders 4th Edition DSM-IV diagnosis of schizophrenia 29510 29520 29530 29560 and 29590 as confirmed by the Kiddie-Sads-Present and Lifetime Version KSADS-PL and who should have a Positive and Negative Syndrome Scale PANSS score that is between 60 and 120 inclusive at screening and baseline Before any study related procedure is performed the patient and his parent or legal guardian must have provided assent and signed an informed consent form respectively The study consists of 3 phases a screening phase a 6-week double-blind treatment phase with an end-of-study or early withdrawal visit and a 1 week follow-up visit for patients who do not enter the optional open-label safety study In the screening phase a trained clinician will complete the K SADS-PL interview including all 5 supplements to confirm the DSM-IV diagnostic criteria for schizophrenia In addition the K-SADS-PL screening diagnostic interview items for suicide must each have a score of 2 as follows item a recurrent thoughts of death item b suicidal thoughts item c suicide attempts and their seriousness item d suicide attempts and their lethality and item e self harming behavior Women of childbearing potential will undergo a urine pregnancy test at screening baseline Week 4 and at end of study or upon early withdrawal from the study Patients who are receiving prohibited medications such as antidepressants lithium drugs of abuse and alcohol will enter a washout period during which medications will be tapered down and eventually stopped The screening and washout phase may not exceed 21 days In the double-blind treatment phase at the baseline visit the inclusion and exclusion criteria will be reviewed Patients who continue to meet the criteria will be randomly assigned as in the toss of a coin to 1 of 4 dose groups Patients weighing between 29 to 51 kilograms kg will receive paliperidone ER 15 30 or 60 milligrams mg or matching placebo Patients weighing 51 kg will receive paliperidone ER 15 60 or 120 mg or matching placebo Patients will come to the study site for weekly visits during this phase A follow-up visit will occur 1 week after the end of treatment for those patients who will not enter the open-label study Efficacy and safety procedures will be performed at specified times during the study Efficacy procedures include the administration of the PANSS Childrens Global Assessment CGAS Clinical Global Impression-Severity CGI-S and a sleep visual analog scale Safety assessments include a physical examination ECG measurements vital signs weight height and waist measurements clinical laboratory testing drug screen Simpson and Angus Scale SAS Barnes Akathisia Rating Scale BARS Abnormal Involuntary Movement Scale AIMS Tanner Staging concomitant medications and the recording of adverse events A Data Safety Monitoring Board will oversee the conduct of the study and review adverse event reports and laboratory test results The total volume of blood drawn for laboratory evaluation throughout the study including 10 milliliters mL for the optional pharmacogenomics testing is approximately 66 mL for each patient Blood samples will be collected to explore the pharmacokinetics of paliperidone in adolescent patients The study hypothesis is that at least 1 paliperidone ER dose group will be superior to placebo in improving the symptoms of schizophrenia as measured by the change in total PANSS score from the baseline to endpoint Week 6 Paliperidone ER 15 30 60 or 120 mg or matching placebo will be administered daily in the morning before 10 am and at approximately the same time each day Study drug administration should occur in a consistent manner relative to the intake of food ie either before or after breakfast or without any breakfast throughout the study Study drug should be swallowed whole and with water Study drug will be administered for 6 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R076477PSZ3001 | None | None | None |