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A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01529515
First received: February 6, 2012
Last updated: May 26, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to evaluate the efficacy of paliperidone palmitate 3 month formulation (PP3M) compared with placebo in delay of the time to first occurrence of relapse of the symptoms of schizophrenia.


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 emulsion)
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, Relapse Prevention Study of Paliperidone Palmitate 3 Month Formulation 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 time to first relapse event in the Double-blind Phase [ Time Frame: Approximately 6 months ] [ Designated as safety issue: No ]
    Time to relapse is defined as the time between randomization to treatment in the Double-Blind Phase and the first documentation of a relapse.


Secondary Outcome Measures:
  • The change in score from baseline to endpoint in Positive and Negative Syndrome Scale (PANSS) (total and subscales) in the Double-blind Phase [ Time Frame: Baseline and approximately 6 months ] [ Designated as safety issue: No ]
    PANSS 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 change from baseline to endpoint in Clinical Global Impression Severity (CGI-S) scale in the Double-blind Phase [ Time Frame: Baseline and approximately 6 months ] [ 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 change from baseline to endpoint in Personal and Social Performance (PSP) scale in the Double-blind Phase [ Time Frame: Baseline and approximately 6 months ] [ 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.


Enrollment: 511
Study Start Date: May 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paliperidone palmitate 3-month (PP3M) Drug: PP3M 175 mg eq.
Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
Drug: PP3M 263 mg eq.
Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
Drug: PP3M 350 mg eq.
Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
Drug: PP3M 525 mg eq.
Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
Placebo Comparator: Placebo Drug: Placebo (20% Intralipid emulsion)
Form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.

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), placebo-controlled (an inactive substance is compared with a drug to test whether the drug has a real effect in a clinical trial) multicenter study. The study consists of 4 phases: a Screening Phase (up to 3 weeks); a 17-week flexible dose open-label Transition Phase (open-label phase means that all people know the identity of the intervention); a 12-week fixed dose open-label Maintenance Phase; and a randomized, double-blind, fixed dose, placebo-controlled relapse prevention phase (referred to as the Double-blind Phase). Patients who meet specific stabilization criteria will enter the Double-blind Phase at Week 29. Patients will be randomly assigned, in a 1:1 ratio, to receive either a fixed dose of PP3M or placebo. The Double-blind Phase will be of variable duration; patients will remain in the study until they experience a relapse event or meet discontinuation criteria.

  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
  • A total score in the Positive and Negative Syndrome Scale (PANSS) < 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: NCT01529515

  Hide Study Locations
Locations
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
San Fran Cisco, California, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Lauderhill, Florida, United States
United States, Illinois
Chicago, Illinois, United States
Hoffman Estates, Illinois, United States
United States, Kansas
Topeka, Kansas, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Mississippi
Flowood, Mississippi, United States
United States, New Jersey
Marlton, New Jersey, United States
United States, New York
Cedarhurst, New York, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Texas
Austin, Texas, United States
Dallas, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
Colombia
Barranquilla, Colombia
Bogota, Colombia
Medellin, Colombia
Pereira, Colombia
Korea, Republic of
Deajun, Korea, Republic of
Gyeongsangnam-Do, Korea, Republic of
Incheon, Korea, Republic of
Seongnam, Korea, Republic of
Malaysia
Johor Bahru, Malaysia
Kuala Lumpur, Malaysia
Tanjong Rambutan, Malaysia
Mexico
Guadajalara, Mexico
Mexico City, Mexico
Monterrey, Mexico
San Luis Potosi, Mexico
Zapopan, Mexico
Romania
Arad, Romania
Craiova, Romania
Iasi, Romania
Sibiu, Romania
Tg Mures, Romania
Turkey
Diyarbakir, Turkey
Sakarya, Turkey
Ukraine
Donetsk, Ukraine
Evpatoriya, Ukraine
Glevakha, Ukraine
Ivano-Frankivsk, Ukraine
Kerch, Ukraine
Kharkiv, Ukraine
Kharkov, Ukraine
Kherson, Ukraine
Kiev, Ukraine
Lviv, Ukraine
Lvov, Ukraine
Odesa, Ukraine
Odessa, Ukraine
Poltava, Ukraine
Smela, Ukraine
Ternopil, Ukraine
Uzhgorod, Ukraine
Vinnitsa, Ukraine
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: NCT01529515     History of Changes
Other Study ID Numbers: CR100717, R092670PSY3012, 2011-004676-11, U1111-1135-1969
Study First Received: February 6, 2012
Last Updated: May 26, 2014
Health Authority: United States: Food and Drug Administration
Ukraine: State Pharmacological Center - Ministry of Health
Turkey: Ministry of Health

Keywords provided by Janssen Research & Development, LLC:
Schizophrenia
R092670
Paliperidone Palmitate
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 November 20, 2014