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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01515423
Registration number
NCT01515423
Ethics application status
Date submitted
17/01/2012
Date registered
24/01/2012
Date last updated
2/05/2016
Titles & IDs
Public title
Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia
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Scientific 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
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Secondary ID [1]
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R092670PSY3011
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Secondary ID [2]
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CR100662
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Schizophrenia
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Condition category
Condition code
Mental Health
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Schizophrenia
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - PP3M 175 mg eq.
Treatment: Drugs - PP3M 263 mg eq.
Treatment: Drugs - PP3M 350 mg eq.
Treatment: Drugs - PP3M 525 mg eq.
Treatment: Drugs - Placebo (20% Intralipid)
Treatment: Drugs - PP1M 50 mg eq.
Treatment: Drugs - PP1M 75 mg eq.
Treatment: Drugs - PP1M 100 mg eq.
Treatment: Drugs - PP1M 150 mg eq.
Experimental: Paliperidone palmitate 3-month (PP3M) - A formulation of paliperidone palmitate with a 3-month injection interval
Active comparator: Paliperidone palmitate 1-month (PP1M) - A formulation of paliperidone palmitate with a 1-month injection interval
Treatment: Drugs: 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.
Treatment: Drugs: 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.
Treatment: Drugs: 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.
Treatment: Drugs: 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.
Treatment: Drugs: Placebo (20% Intralipid)
Form= injection, route= intramuscular use. One injection monthly when not receiving active medication for 48 weeks.
Treatment: Drugs: PP1M 50 mg eq.
Type= exact number, unit= mg eq., number= 50, form= injection, route= intramuscular use. One injection every month for 48 weeks.
Treatment: Drugs: PP1M 75 mg eq.
Type= exact number, unit= mg eq., number= 75, form= injection, route= intramuscular use. One injection every month for 48 weeks.
Treatment: Drugs: PP1M 100 mg eq.
Type= exact number, unit= mg eq., number= 100, form= injection, route= intramuscular use. One injection every month for 48 weeks.
Treatment: Drugs: PP1M 150 mg eq.
Type= exact number, unit= mg eq., number= 150, form= injection, route= intramuscular use. One injection every month for 48 weeks.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 48 weeks
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Secondary outcome [1]
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Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48
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Assessment method [1]
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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).
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Timepoint [1]
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DB Baseline (Week 17) and 48 week or DB Endpoint
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Secondary outcome [2]
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Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48
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Assessment method [2]
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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.
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Timepoint [2]
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DB Baseline (Week 17) and 48 week or DB Endpoint
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Secondary outcome [3]
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Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48
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Assessment method [3]
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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.
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Timepoint [3]
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DB Baseline (Week 17) and 48 week or DB Endpoint
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Secondary outcome [4]
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Percentage of Participants Who Met the Criteria for Symptomatic Remission Based on Andreasen Criteria
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Assessment method [4]
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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.
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Timepoint [4]
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Weeks 41 to 65
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Secondary outcome [5]
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Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48
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Assessment method [5]
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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).
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Timepoint [5]
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DB Baseline (Week 17) and 48 week or DB Endpoint
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Secondary outcome [6]
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Change From Baseline in Marder Factor Subscale Score at Week 48
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Assessment method [6]
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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.
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Timepoint [6]
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DB Baseline (Week 17) and 48 week or DB Endpoint
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Eligibility
Key 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)
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Minimum age
18
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Maximum age
70
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2015
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Sample size
Target
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Accrual to date
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Final
1429
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Elizabeth Vale
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Recruitment hospital [2]
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- Frankston
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Recruitment postcode(s) [1]
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- Elizabeth Vale
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Recruitment postcode(s) [2]
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- Frankston
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Recruitment outside Australia
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Arkansas
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Toki
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0
Japan
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Tokushima
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0
Japan
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Tokyo
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Japan
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0
Toyoake
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0
Japan
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State/province [108]
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0
Ueda
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0
0
Japan
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0
Yatsushiro
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0
Japan
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0
Yokkaichi
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Japan
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Yokohama
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Korea, Republic of
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Busan
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Korea, Republic of
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Gwangju-Si
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Korea, Republic of
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Gyeonggi-Do
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Korea, Republic of
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Seoul
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Mexico
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Guadalajara
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Mexico
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Monterrey
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Mexico
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Tlalnepantla
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Poland
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Belchatow
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Poland
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Bydgoszcz
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Poland
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Chelmno
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Poland
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Gdynia Na
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Poland
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Lubin
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Poland
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Lubliniec
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Poland
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Piekary Slaskie
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Poland
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Torun N/A
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Poland
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Zabki
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Portugal
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Almada N/A
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Portugal
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Angra Do Heroísmo
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Porto
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Romania
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Brasov
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Romania
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Cluj-Napoca
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Russian Federation
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Arkhangelsk
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Russian Federation
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Ekaterinburg
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Russian Federation
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Gatchina
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Russian Federation
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Krasnodar N/A
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Russian Federation
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Moscow N/A
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Saratov
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Russian Federation
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Smolensk Region N/A
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Russian Federation
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Smolensk
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Russian Federation
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St Petersburg
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Russian Federation
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St-Peterburg
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Russian Federation
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St-Petersburg
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Russian Federation
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Tomsk Na
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Russian Federation
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Yaroslavl
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Slovakia
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Bratislava
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Slovakia
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Michalovce
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Slovakia
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Rimavska Sobota
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Slovakia
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Trencin
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Spain
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Alicante
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Spain
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Baracaldo
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Spain
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Barcelona
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Country [156]
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Spain
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Coslada
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Spain
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Elche
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Spain
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Madrid
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Country [159]
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Spain
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Zamora
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Sweden
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Uppsala
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Taiwan
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Bali Township, Taipei County
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Country [162]
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Taiwan
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Kaohsiung
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Taiwan
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Taoyuan
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Ukraine
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State/province [164]
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Glevakha
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Country [165]
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Ukraine
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Kharkov
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Ukraine
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Kiev
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Ukraine
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Odessa
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Ukraine
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State/province [168]
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Poltava
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT01515423
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Trial related presentations / publications
Gopal S, Gogate J, Pungor K, Kim E, Singh A, Mathews M. Improvement of Negative Symptoms in Schizophrenia with Paliperidone Palmitate 1-Month and 3-Month Long-Acting Injectables: Results from a Phase 3 Non-Inferiority Study. Neuropsychiatr Dis Treat. 2020 Mar 6;16:681-690. doi: 10.2147/NDT.S226296. eCollection 2020. Savitz AJ, Xu H, Gopal S, Nuamah I, Mathews M, Soares B. Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies. Braz J Psychiatry. 2019 Nov-Dec;41(6):499-510. doi: 10.1590/1516-4446-2018-0153. Nash AI, Turkoz I, Savitz AJ, Mathews M, Kim E. Predictors of achieving remission in schizophrenia patients treated with paliperidone palmitate 3-month formulation. Neuropsychiatr Dis Treat. 2019 Mar 22;15:731-737. doi: 10.2147/NDT.S194264. eCollection 2019. Mathews M, Pei H, Savitz A, Nuamah I, Hough D, Alphs L, Gopal S. Paliperidone Palmitate 3-Monthly Versus 1-Monthly Injectable in Patients With Schizophrenia With or Without Prior Exposure to Oral Risperidone or Paliperidone: A Post Hoc, Subgroup Analysis. Clin Drug Investig. 2018 Aug;38(8):695-702. doi: 10.1007/s40261-018-0647-z. Magnusson MO, Samtani MN, Plan EL, Jonsson EN, Rossenu S, Vermeulen A, Russu A. Population Pharmacokinetics of a Novel Once-Every 3 Months Intramuscular Formulation of Paliperidone Palmitate in Patients with Schizophrenia. Clin Pharmacokinet. 2017 Apr;56(4):421-433. doi: 10.1007/s40262-016-0459-3. Samtani MN, Nandy P, Ravenstijn P, Remmerie B, Vermeulen A, Russu A, D'hoore P, Baum EZ, Savitz A, Gopal S, Hough D. Prospective dose selection and acceleration of paliperidone palmitate 3-month formulation development using a pharmacometric bridging strategy. Br J Clin Pharmacol. 2016 Nov;82(5):1364-1370. doi: 10.1111/bcp.13050. Epub 2016 Jul 24.
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Public notes
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Contacts
Principal investigator
Name
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01515423
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