Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01515423
First received: January 17, 2012
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M.


Condition Intervention Phase
Schizophrenia
Drug: PP3M 175 mg eq.
Drug: PP3M 263 mg eq.
Drug: PP3M 350 mg eq.
Drug: PP3M 525 mg eq.
Drug: Placebo (20% Intralipid)
Drug: PP1M 50 mg eq.
Drug: PP1M 75 mg eq.
Drug: PP1M 100 mg eq.
Drug: PP1M 150 mg eq.
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • The percentage of patients who have not relapsed at the end of the 48-week Double-blind Phase. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    This will be determined based on the Kaplan-Meier 48-week cumulative estimate of survival (ie, percentage of subjects remaining relapse free).


Secondary Outcome Measures:
  • The changes from baseline in the neuropsychiatric symptoms of schizophrenia using the Positive and Negative Syndrome Scale (PANSS) during the Double-blind Phase. [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
    The PANSS scale provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items). Each item is rated 1 (absent) to 7 (extreme).

  • The changes from baseline in the patient's overall clinical condition measured by the change in Clinical Global Impression Severity (CGI-S) scale during the Double-blind Phase. [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
    The CGI-S rating scale is used to rate the severity of a patient's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe).

  • The changes from baseline in the patient's functional status, measured by the Personal and Social Performance (PSP) scale during the Double-blind Phase. [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
    The PSP scale measures personal and social functioning in the domains of: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior.

  • The proportion of patients who meet criteria for symptomatic remission. [ Time Frame: Week 41 to 65 ] [ Designated as safety issue: No ]
    The proportion of patients with a simultaneous score of mild or less on all selected PANSS items (P1, P2, P3, N1, N4, N6, G5, and G9) maintained from Visit 14 (Week 41) to the end of the Double-blind Phase (Week 65).


Enrollment: 1430
Study Start Date: May 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paliperidone palmitate 3-month (PP3M)
A formulation of paliperidone palmitate with a 3-month injection interval
Drug: PP3M 175 mg eq.
Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every third month for 48 weeks.
Drug: PP3M 263 mg eq.
Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every third month for 48 weeks.
Drug: PP3M 350 mg eq.
Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every third month for 48 weeks.
Drug: PP3M 525 mg eq.
Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every third month for 48 weeks.
Drug: Placebo (20% Intralipid)
Form= injection, route= intramuscular use. One injection monthly when not receiving active medication for 48 weeks.
Active Comparator: Paliperidone palmitate 1-month (PP1M)
A formulation of paliperidone palmitate with a 1-month injection interval
Drug: PP1M 50 mg eq.
Type= exact number, unit= mg eq., number= 50, form= injection, route= intramuscular use. One injection every month for 48 weeks.
Drug: PP1M 75 mg eq.
Type= exact number, unit= mg eq., number= 75, form= injection, route= intramuscular use. One injection every month for 48 weeks.
Drug: PP1M 100 mg eq.
Type= exact number, unit= mg eq., number= 100, form= injection, route= intramuscular use. One injection every month for 48 weeks.
Drug: PP1M 150 mg eq.
Type= exact number, unit= mg eq., number= 150, form= injection, route= intramuscular use. One injection every month for 48 weeks.

Detailed Description:

This is a randomized (the study drug is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel group (each group of patients will be treated at the same time), multicenter non-inferiority (the effect of the new treatment is not worse than that of the comparison treatment) study. A new formulation of paliperidone palmitate with a 3-month injection interval (PP3M) is being tested for use as maintenance treatment for subjects with schizophrenia who have been first stabilized on paliperidone palmitate with a 1-month injection interval (PP1M). The study consists of 3 phases: a screening/washout/tolerability phase (up to 21 days); a 17-week open-label (all people know the identity of the intervention) stabilization phase (referred to as the Open-label Phase) and a 48-week fixed dose, randomized, double-blind controlled phase (referred to as the Double-blind Phase). After completion of the Screening Phase, all patients will receive PP1M in the Open-label Phase. During this time, flexible dosing will occur at Weeks 5 and 9. At Week 13 patients are to receive the dose of PP1M that was administered at Week 9. Patients who are clinically stable at the end of the Open-label Phase will enter the Double-blind Phase and will be randomly assigned in a 1:1 ratio to receive fixed doses of PP3M or PP1M.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with schizophrenia for more than 1 year and whose symptoms are worsening in the opinion of the investigator
  • A total score in the Positive and Negative Syndrome Scale (PANSS) between 70 and 120
  • Signed informed consent
  • Women must not be pregnant, breastfeeding, and if capable of pregnancy must practice an effective method of birth control
  • Men must agree to use a double-barrier method of birth control
  • Be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs, and electrocardiogram (ECG)

Exclusion Criteria:

  • A diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia-related psychosis
  • Relevant history or current presence of any significant or unstable medical condition(s) determined to be clinically significant by the Investigator (ie, obesity, diabetes, heart disease etc)
  • A diagnosis of substance dependence within 6 months before screening
  • History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia
  • Clozapine use in the last 2 months when used for treatment-resistant or treatment-refractory illness
  • Clinically significant findings in biochemistry, hematology, ECG or urinalysis results
  • Any other disease or condition that, in the opinion of the investigator, would make participation not in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01515423

  Show 177 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01515423     History of Changes
Other Study ID Numbers: CR100662, R092670PSY3011, 2011-004889-15, U1111-1135-7054
Study First Received: January 17, 2012
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration
China: Ethics Committee
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Ukraine: State Pharmacological Center - Ministry of Health
Bulgaria: Bulgarian Drug Agency
Japan: Pharmaceuticals and Medical Devices Agency
Czech Republic: State Institute for Drug Control

Keywords provided by Janssen Research & Development, LLC:
Schizophrenia
R092670
Paliperidone Palmitate
Paliperidone palmitate 1 month formulation (PP1M)
Paliperidone palmitate 3 month formulation (PP3M)

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
9-hydroxy-risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 20, 2014