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Comparison of Paliperidone Palmitate and Risperdal Consta in Patients With Schizophrenia
This study is currently recruiting participants.
Verified by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., December 2008
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00589914
  Purpose

The primary objective of this study is to demonstrate that the effectiveness of paliperidone palmitate in patient with Schizophrenia.


Condition Intervention Phase
Schizophrenia
Drug: Paliperidone Palmitate
Drug: RISPERDAL CONSTA
Phase III

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone Paliperidone Paliperidone Palmitate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Double-Blind, Parallel-Group, Comparative Study of Flexible Doses of Paliperidone Palmitate and Flexible Doses of Risperidone Long-Acting Intramuscular Injection in Subjects With Schizophrenia

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Change from baseline in total PANSS score [ Time Frame: 13 wks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in CGI-S, Change from baseline in PSP, Change from baseline in SDS, Change from baseline in PSQI and sleep VAS, Change from baseline in PANSS subscales, Responder rate [ Time Frame: 13 wks ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: February 2007
Estimated Study Completion Date: March 2009
Arms Assigned Interventions
001: Experimental Drug: Paliperidone Palmitate
50-150 mg eq every 4 wks
002: Active Comparator Drug: RISPERDAL CONSTA
25-50 mg eq every 2 weeks

Detailed Description:

The primary hypothesis is that at the endpoint of the study (Week 13), paliperidone palmitate is noninferior to RISPERDAL CONSTA in the treatment of schizophrenia as defined by the upper limit of the confidence interval (CI) of the difference between RISPERDAL CONSTA and paliperidone palmitate on change in total Positive and Negative Syndrome Scale (PANSS) score not exceeding 5 points.This is a randomized, double-blind, double-dummy, active-controlled, parallel-group, multicenter, comparative study in approximately 700 men and women (350 in each arm) aged 18 years or older who meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for schizophrenia for at least 1 year, a total PANSS score of 60 to 120, inclusive. Secondary objectives include the following: Assessment of the global improvement in severity of illness associated with the use of paliperidone palmitate compared with RISPERDAL CONSTA, Examining the effects to personal and social functioning associated with the use of paliperidone palmitate compared with RISPERDAL CONSTA, Examine the effects of paliperidone palmitate compared with RISPERDAL CONSTA in improvement of sleep quality and reduction of daytime sleepiness The study consists of 2 periods: a 7-day screening/washout period and a 13-week double-blind treatment period. The screening period will include up to 7 days for the washout of previous disallowed psychotropic medications and up to 6 days for oral tolerability testing with paliperidone extended release (ER), if necessary. Washout and tolerability testing may overlap. During the treatment period, patients will be randomized in a 1 to 1 ratio to receive either paliperidone palmitate or RISPERDAL CONSTA. Doses may be adjusted depending on efficacy or tolerability. End of study/early withdrawal assessments will be done 2 weeks after the last dose of study drug (Day 92) for all patients completing the study. For patients withdrawing from the study early, end-of-study/early withdrawal assessments will be done at the time of withdrawal. The total duration of the study will be approximately 14 weeks.Safety, tolerability, efficacy, and exploratory assessments will be done periodically throughout the study. A pharmacogenomic blood sample will be collected from patients who give a separate, written informed consent for this part of the study (where local regulations permit). This will allow for pharmacogenomic research, as necessary. Participation in pharmacogenomic research is optional.

Paliperidone palmitate will be administered using a dosing regimen that includes an initial i.m. injection of paliperidone palmitate 150 mg eq. at baseline, a second injection of 100 mg eq. paliperidone palmitate at Visit 4 (Day 8), and subsequent injections of paliperidone palmitate every 4 weeks, at Visit 7 (Day 36) and Visit 9 (Day 64). Depending on tolerability and efficacy, the investigator will be permitted to flexibly dose paliperidone palmitate.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meet diagnostic criteria for schizophrenia according to DSM-IV (disorganized type [295.10], catatonic type [295.20], paranoid type [295.30], residual type [295.60], or undifferentiated type [295.90]) for at least 1 year before screening. Prior medical records, written documentation or verbal information obtained from previous psychiatric providers obtained by the investigator must be consistent with the diagnosis of schizophrenia
  • A total PANSS score between 60 and 120, inclusive, at screening and baseline
  • Body mass index (BMI) at the screening visit BMI >=17 kg/m2
  • Female patients must be postmenopausal for at least 2 years, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before study entry and throughout the study. Effective methods of birth control include contraceptive pills, coil, depot injection of gestagen, subdermal implantation, hormonal vaginal ring, and transdermal depot patches. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (b hCG) pregnancy test result at screening

Exclusion Criteria:

  • Unable to provide their own consent or involuntarily committed to psychiatric hospitalization
  • A primary, active DSM-IV diagnosis on Axis I other than schizophrenia
  • A decrease of >25% in the total PANSS score between screening and baseline as calculated using the table provided by the sponsor
  • Patients who have previously been randomized into this study
  • A DSM-IV diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
  • History of treatment resistance as defined by failure to respond to 2 adequate treatments with different antipsychotic medications (an adequate treatment is defined as a minimum of 6 weeks at maximum tolerated dosage)
  • Relevant history or current presence of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular disease), renal, hepatic, hematologic, endocrine, immunologic, morbid obesity (BMI >=40 kg/m2), or other systemic disease
  • History of any severe pre-existing gastrointestinal narrowing (pathologic or iatrogenic) or inability to swallow oral study drug whole with the aid of water (applies to those patients requiring oral tolerability only)
  • Serum chemistry, hematology, or urinalysis results that are not within the laboratory's normal reference range and are deemed to be clinically significant by the investigator
  • History or evidence of clinically significant hepatic disease [including aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 times the upper limit of normal] at screening - History of neuroleptic malignant syndrome (NMS)
  • Significant risk of suicidal or violent behavior, as clinically assessed by the investigator - History of life-threatening allergic reaction to any drug
  • Known or suspected hypersensitivity or intolerance to risperidone, paliperidone, 20% Intralipid, or any of their excipients (e.g., soybean oil, egg yolks, phospholipids, and glycerol)
  • Have received an experimental drug or experimental biologic, or used an experimental medical device within 6 months before screening
  • History of any active malignancy within the previous 5 years, with the exception of basal cell carcinomas
  • A woman who is pregnant or breast-feeding or is planning to become pregnant during the study
  • Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator
  • Patients who have participated in 2 or more clinical trials in the past year, or in 1 clinical trial in the past 6 months (non-intervention, observational, and retrospective studies excluded)
  • History of disallowed therapies: An injectable antipsychotic within 1 injection interval before screening, Use of clozapine in the 3 months before baseline, Risperidone LAI injection within 6 weeks before screening, A previous injection of paliperidone palmitate within the past 10 months before baseline, Electroconvulsive therapy (ECT) with 60 days before screening, Nonselective/irreversible MAOI antidepressants within 30 days before screening, Other antidepressants unless at a stable dosage for 30 days before screening or, unless the antidepressant is not necessary, and can be washed out by the baseline visit, Mood stabilizers, including lithium and all anticonvulsants, are not allowed during the double-blind period, and also must be washed out by Day -1. The duration of the washout is up to the discretion of the investigator but in general should be 5 multiples of the elimination half-life, Beta-blockers, must be washed out by Day -1. The duration of the washout is up to the discretion of the investigator but in general should be 5 multiples of the elimination half-life. Beta blocker use can be re-initiated after randomization depending on clinical need. At each subsequent visit, the investigator should determine whether continuation of the beta-blocker is required, Other prescription, OTC, or herbal agents with psychoactive properties are not allowed during the double-blind period, and also must be washed out by Day -1. The duration of the washout is up to the discretion of the investigator but in general should be 5 multiples of the elimination half-life - History or presence of circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval - The following cardiac conditions: sick sinus syndrome, complete AV block, congestive heart failure, polymorphic ventricular tachycardiaClinically relevant hypocalcemia, hypokalemia or hypomagnesemia
  • Concomitant use of drugs that prolong the QTc interval Presence of congenital prolongation of the QT interval
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00589914

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: info1@veritasmedicine.com

  Show 99 Study Locations
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

To learn how to participate in this trial please click here.  This link exits the ClinicalTrials.gov site

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. ( Compound Development Team Leader, Paliperidone )
Study ID Numbers: CR012289, R092670PSY3006
Study First Received: December 21, 2007
Last Updated: December 18, 2008
ClinicalTrials.gov Identifier: NCT00589914  
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
long-acting injectable antipsychotic medication
Schizophrenia

Study placed in the following topic categories:
Schizophrenia
Dopamine
Mental Disorders
Risperidone
9-hydroxy-risperidone
Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009