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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

January 17, 2012
September 10, 2014
May 2012
February 2015   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01515423 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia
A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects With Schizophrenia

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • 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.
  • 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.
  • Experimental: Paliperidone palmitate 3-month (PP3M)
    A formulation of paliperidone palmitate with a 3-month injection interval
    Interventions:
    • Drug: PP3M 175 mg eq.
    • Drug: PP3M 263 mg eq.
    • Drug: PP3M 350 mg eq.
    • Drug: PP3M 525 mg eq.
    • Drug: Placebo (20% Intralipid)
  • Active Comparator: Paliperidone palmitate 1-month (PP1M)
    A formulation of paliperidone palmitate with a 1-month injection interval
    Interventions:
    • Drug: PP1M 50 mg eq.
    • Drug: PP1M 75 mg eq.
    • Drug: PP1M 100 mg eq.
    • Drug: PP1M 150 mg eq.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1430
May 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   China,   Czech Republic,   France,   Germany,   Greece,   Hungary,   Japan,   Korea, Republic of,   Mexico,   Poland,   Portugal,   Romania,   Russian Federation,   Slovakia,   Spain,   Sweden,   Taiwan,   Ukraine
 
NCT01515423
CR100662, R092670PSY3011, 2011-004889-15, U1111-1135-7054
No
Janssen Research & Development, LLC
Janssen Research & Development, LLC
Not Provided
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Janssen Research & Development, LLC
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP