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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01515423
Recruitment Status : Completed
First Posted : January 24, 2012
Results First Posted : May 2, 2016
Last Update Posted : May 2, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment 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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1429 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2012
Primary Completion Date : February 2015
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase [ Time Frame: Up to 48 weeks ]
    Relapse defined as: Psychiatric hospitalization;participant had an increase of 25 percent in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was greater than (>) 40; had a 10 point increase in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was less than or equal to (<=) 40; deliberate self-injury or exhibited violent behavior resulting in suicide, clinically significant injury;suicidal or homicidal ideation and aggressive behavior;For PANSS items-had a score of greater than or equal to (>=) 5 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was <=3 at randomization; had a score of >=6 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was 4 at randomization.


Secondary Outcome Measures :
  1. Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48 [ Time Frame: DB Baseline (Week 17) and 48 week or DB Endpoint ]
    The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology).

  2. Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48 [ Time Frame: DB Baseline (Week 17) and 48 week or DB Endpoint ]
    The Clinical Global Impression Severity (CGI-S) rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening.

  3. Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48 [ Time Frame: DB Baseline (Week 17) and 48 week or DB Endpoint ]
    The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100. Participants with a score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.

  4. Percentage of Participants Who Met the Criteria for Symptomatic Remission Based on Andreasen Criteria [ Time Frame: Weeks 41 to 65 ]
    Symptomatic remission criterion was defined as having a simultaneous score of mild or less on all selected PANSS items (P1, P2, P3, N1, N4, N6, G5, and G9). Symptomatic remission was defined for the last 6 months of the Double-blind Phase as meeting the remission criterion during the 6 months prior to the End of study visit during the Double-blind Phase, with one excursion allowed.

  5. Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48 [ Time Frame: DB Baseline (Week 17) and 48 week or DB Endpoint ]
    The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology).

  6. Change From Baseline in Marder Factor Subscale Score at Week 48 [ Time Frame: DB Baseline (Week 17) and 48 week or DB Endpoint ]
    5 PANSS Marder factor scores (positive symptoms [range:8 to 56], negative symptoms [range: 7 to 49], disorganized thoughts [range: 7 to 49], uncontrolled hostility/excitement [range: 4 to 28], and anxiety/depression [range: 4 to 28]) were examined to gain insight into the symptoms affected by treatment with the study drug. Negative change from baseline in subscales score for positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression indicates improvement in various symptoms of schizophrenia.


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01515423


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Locations
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Glendale, California, United States
Long Beach, California, United States
Oakland, California, United States
Oceanside, California, United States
Orange, California, United States
San Diego, California, United States
United States, Connecticut
New Britain, Connecticut, United States
United States, Florida
Bradenton, Florida, United States
Kissimmee, Florida, United States
Tampa, Florida, United States
United States, Kansas
Wichita, Kansas, United States
United States, Michigan
East Lansing, Michigan, United States
United States, Missouri
St. Louis, Missouri, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New York
Jamaica, New York, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Ohio
Canton, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
United States, Tennessee
Memphis, Tennessee, United States
United States, Texas
Austin, Texas, United States
United States, Washington
Bothell, Washington, United States
Argentina
Buenos Aires, Argentina
Cordoba, Argentina
Córdoba, Argentina
Rosario, Argentina
Australia
Elizabeth Vale, Australia
Frankston, Australia
Austria
Innsbruck, Austria
Belgium
Assebroek, Belgium
Bertrix, Belgium
Brussel - Jette, Belgium
Dave, Belgium
Heusden, Belgium
Marchienne-Au-Pont, Belgium
Sint-Denijs-Westrem, Belgium
Brazil
Rio De Janeiro, Brazil
Bulgaria
Bourgas N/A, Bulgaria
Kazanlak, Bulgaria
Radnevo, Bulgaria
Sofia, Bulgaria
Canada, Alberta
Calgary, Alberta, Canada
Canada, Ontario
Halifax, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Canada
Burlington, Canada
China
Baoding, China
Beijing, China
Changsha, China
Guangdong, China
Guangzhou, China
Hangzhou, China
Kunming, China
Shanghai, China
Tianjin, China
Wuhan, China
Xi'An, China
Czech Republic
Brno, Czech Republic
Horovice, Czech Republic
Liberec, Czech Republic
Praha 10, Czech Republic
Praha 9, Czech Republic
Prerov, Czech Republic
France
Clermont Ferrand, France
Dole, France
Montpellier, France
Toulon, France
Germany
Bochum, Germany
Gelsenkirchen, Germany
Hamburg, Germany
Heidelberg, Germany
München, Germany
Greece
Arta, Greece
Athens, Greece
Katerini, Greece
Hungary
Balassagyarmat N/A, Hungary
Budapest, Hungary
Gyõr, Hungary
Kalocsa, Hungary
Sopron, Hungary
Japan
Aizuwakamatsu, Japan
Fujioka, Japan
Fujisawa, Japan
Hadano, Japan
Himeji, Japan
Hitachi, Japan
Ichikawa, Japan
Kanuma, Japan
Kanzaki, Japan
Kashihara, Japan
Kashiwara, Japan
Kasuya, Japan
Kawasaki, Japan
Kitagunma, Japan
Kochi, Japan
Kodaira, Japan
Kumagaya, Japan
Kumamoto, Japan
Kure, Japan
Matsusaka, Japan
Mitaka, Japan
Moriguchi, Japan
Nagasaki, Japan
Naha, Japan
Nirasaki, Japan
Ohta, Japan
Okayama, Japan
Okinawa, Japan
Sakai, Japan
Shibukawa, Japan
Takatsuki, Japan
Toki, Japan
Tokushima, Japan
Tokyo, Japan
Toyoake, Japan
Ueda, Japan
Yatsushiro, Japan
Yokkaichi, Japan
Yokohama, Japan
Korea, Republic of
Busan, Korea, Republic of
Gwangju-Si, Korea, Republic of
Gyeonggi-Do, Korea, Republic of
Seoul, Korea, Republic of
Mexico
Guadalajara, Mexico
Monterrey, Mexico
Tlalnepantla, Mexico
Poland
Belchatow, Poland
Bydgoszcz, Poland
Chelmno, Poland
Gdynia Na, Poland
Lubin, Poland
Lubliniec, Poland
Piekary Slaskie, Poland
Torun N/A, Poland
Zabki, Poland
Portugal
Almada N/A, Portugal
Angra Do Heroísmo, Portugal
Coimbra, Portugal
Lisboa, Portugal
Porto, Portugal
Romania
Brasov, Romania
Cluj-Napoca, Romania
Russian Federation
Arkhangelsk, Russian Federation
Ekaterinburg, Russian Federation
Gatchina, Russian Federation
Krasnodar N/A, Russian Federation
Moscow N/A, Russian Federation
Nizhniy Novgorod, Russian Federation
Saratov, Russian Federation
Smolensk Region N/A, Russian Federation
Smolensk, Russian Federation
St Petersburg, Russian Federation
St-Peterburg, Russian Federation
St-Petersburg, Russian Federation
Tomsk Na, Russian Federation
Yaroslavl, Russian Federation
Slovakia
Bratislava, Slovakia
Michalovce, Slovakia
Rimavska Sobota, Slovakia
Trencin, Slovakia
Spain
Alicante, Spain
Baracaldo, Spain
Barcelona, Spain
Coslada, Spain
Elche, Spain
Madrid, Spain
Zamora, Spain
Sweden
Uppsala, Sweden
Taiwan
Bali Township, Taipei County, Taiwan
Kaohsiung, Taiwan
Taoyuan, Taiwan
Ukraine
Glevakha, Ukraine
Kharkov, Ukraine
Kiev, Ukraine
Odessa, Ukraine
Poltava, Ukraine
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01515423     History of Changes
Other Study ID Numbers: CR100662
R092670PSY3011 ( Other Identifier: Janssen Research & Development, LLC )
2011-004889-15 ( EudraCT Number )
U1111-1135-7054 ( Other Identifier: Universal Trial Number )
First Posted: January 24, 2012    Key Record Dates
Results First Posted: May 2, 2016
Last Update Posted: May 2, 2016
Last Verified: April 2016

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
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Paliperidone Palmitate
Soybean oil, phospholipid emulsion
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions