1/30/2020
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`History of Changes for Study: NCT00111189
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`History of Changes for Study: NCT00111189
`
`Evaluate the Efficacy in the Prevention of Recurrence of the Symptoms of Schizophrenia
`
`Latest version (submitted June 19, 2014) on ClinicalTrials.gov
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`A study version is represented by a row in the table.
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`currently being viewed.
`
`Hover over the "Recruitment Status" to see how the study's recruitment status changed.
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`Study edits or deletions are displayed in red.
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`Study additions are displayed in green .
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`Study Record Versions
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`Version
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`B
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`Submitted Date
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`Changes
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`June 23, 2005 None (earliest Version on record)
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`August 18, 2005 Contacts/Locations, Study Status, Sponsor/Collaborators and Study Identification
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`April 17, 2006 Contacts/Locations, Study Status, Outcome Measures and Study Design
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`January 3, 2007 Recruitment Status, Study Status, Contacts/Locations and Study Design
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`July 17, 2007 Study Status and Contacts/Locations
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`December 26, 2007 Arms and Interventions, Study Design, Outcome Measures, Study Status,
`Sponsor/Collaborators and Study Identification
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`February 26, 2008 Study Status and Study Identification
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`February 28, 2008 Study Status, Contacts/Locations, Study Description, Study Identification, Eligibility,
`Outcome Measures, Study Design, Conditions and Sponsor/Collaborators
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`November 13, 2008 Recruitment Status and Study Status
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`June 29, 2009 Study Status, References, Contacts/Locations, Eligibility, Study Design, Study
`Description and Oversight
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`July 8, 2009 References and Study Status
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`August 28, 2009 Study Status, References and Study Design
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`https://clinicaltrials.gov/ct2/history/NCT00111189?V_3=View#StudyPageTop
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`1/30/2020
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`History of Changes for Study: NCT00111189
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`Version
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`B
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`Submitted Date
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`Changes
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`May 11, 2010 Study Status
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`May 13, 2010 Study Status, Arms and Interventions and Study Design
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`November 18, 2010 Study Status
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`May 17, 2011 References and Study Status
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`June 2, 2011 Study Status
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`June 19, 2014 Sponsor/Collaborators, Study Status, Contacts/Locations, Study Design and Oversight
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`Compare
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`Study NCT00111189
`Submitted Date: April 17, 2006 (v3)
`
`Study Identification
`Unique Protocol ID: R092670-PSY-3001
`Brief Title: Evaluate the Efficacy in the Prevention of Recurrence of the Symptoms of
`Schizophrenia
`Official Title: A Randomized Double-Blind Placebo-Controlled Parallel Group Study Evaluating
`Paliperidone Palmitate in the Prevention of Recurrence in Subjects With
`Schizophrenia
`
`Secondary IDs:
`
`Study Status
`
`Record Verification: April 2006
`Overall Status: Recruiting
`Study Start: March 2005
`Primary Completion:
`Study Completion:
`
`First Submitted: May 17, 2005
`First Submitted that
`May 17, 2005
`Met QC Criteria:
`First Posted: May 18, 2005 [Estimate]
`
`April 17, 2006
`
`Last Update Submitted that
`Met QC Criteria:
`Last Update Posted: April 19, 2006 [Estimate]
`Sponsor/Collaborators
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`https://clinicaltrials.gov/ct2/history/NCT00111189?V_3=View#StudyPageTop
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`History of Changes for Study: NCT00111189
`Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
`Responsible Party:
`Collaborators: Janssen-Cilag International NV
`
`Oversight
`U.S. FDA-regulated Drug:
`U.S. FDA-regulated Device:
`Data Monitoring:
`Study Description
`Brief Summary: The purpose of this study is to evaluate the efficacy of paliperidone palmitate
`compared with placebo (sometimes called a sugar pill) in the prevention of recurrence
`of the symptoms of schizophrenia and to assess the safety and tolerability of
`paliperidone palmitate in subjects with stable and symptomatic schizophrenia.
`
`Detailed Description:
`
`Conditions
`
`Study Design
`
`Conditions: Schizophrenia
`Keywords:
`
`Study Type: Interventional
`Primary Purpose: Prevention
`Study Phase: Phase 3
`Interventional Study Model:
`Number of Arms:
`Masking: (masked roles unspecified)
`Allocation: N/A
`Enrollment: 640
`Arms and Interventions
`Intervention Details:
`Drug: R092670
`Outcome Measures
`Primary Outcome Measures:
`1. The primary efficacy criteria for this study is the time from randomization to the first recurrence event during the
`double-blind recurrence prevention period
`
`Eligibility
`
`Minimum Age: 18 Years
`Maximum Age: 65 Years
`Sex: All
`Gender Based:
`Accepts Healthy Volunteers: No
`Criteria: Inclusion Criteria:
`
`https://clinicaltrials.gov/ct2/history/NCT00111189?V_3=View#StudyPageTop
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`History of Changes for Study: NCT00111189
`Meet the diagnostic criteria for schizophrenia according to DSM-IV-TM for at
`least 1 year before screening;
`PANSS score of <120;
`BMI > or equal to 15.0;
`Effective birth control or postmenopausal for at least 2 years;
`reside at the same address for at least 30 days
`
`Exclusion Criteria:
`
`subjects unable to provide their own consent;
`involuntarily committed to psychiatric hospitalization;
`history of any severe preexisting gastrointestinal narrowing or inability to
`swallow the medication whole with water;
`female subjects who are pregnant, breastfeeding, or planning to become
`pregnant;
`MAOI antidepressants;
`hypersensitivity to egg yolks, soybean oil, phospholipids, and glycerol
`
`Contacts/Locations
`Study Officials: Marielle Eerdekens
`Study Director
`Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
`Locations: United States, Arkansas
`[Recruiting]
`Little Rock, Arkansas, United States, 72201
`Contact: Study Coordinator 501-378-0400
`United States, California
`[Recruiting]
`Santa Ana, California, United States, 92705
`Contact: Study Coordinator 714-547-4100
`United States, Florida
`[Recruiting]
`Hialeah, Florida, United States, 33016
`Contact: Study Coordinator 305-702-9453
`United States, Illinois
`[Recruiting]
`Chicago, Illinois, United States, 60640
`Contact: Study Coordinator 773-989-9871
`[Recruiting]
`Granite City, Illinois, United States, 62040
`Contact: Study Coordinator 618-876-7256
`United States, Louisiana
`[Recruiting]
`Lake Charles, Louisiana, United States, 70601
`Contact: Study Coordinator 337-494-3266
`[Recruiting]
`Shreveport, Louisiana, United States, 71101
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`https://clinicaltrials.gov/ct2/history/NCT00111189?V_3=View#StudyPageTop
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`History of Changes for Study: NCT00111189
`Contact: Study Coordinator 318-227-4565
`United States, Missouri
`[Recruiting]
`St. Louis, Missouri, United States, 63118
`Contact: Study Coordinator 314-614-1500
`United States, New Jersey
`[Recruiting]
`Clementon, New Jersey, United States, 08021
`Contact: Study Coordinator 856-566-9000
`United States, New York
`[Recruiting]
`Lawrence, New York, United States, 11559
`Contact: Study Coordinator 516-295-7230
`United States, Ohio
`[Recruiting]
`Cleveland, Ohio, United States, 44109
`Contact: Study Coordinator 216-739-0408
`United States, Oklahoma
`[Recruiting]
`Oklahoma City, Oklahoma, United States, 73103
`Contact: Study Coordinator 405-235-8188
`United States, Pennsylvania
`[Not yet recruiting]
`Philadelphia, Pennsylvania, United States, 19131
`Contact: Study Coordinator 215-581-3777
`United States, Texas
`[Recruiting]
`Austin, Texas, United States, 78756
`Contact: Study Coordinator 512-323-2622
`[Recruiting]
`Conroe, Texas, United States, 77304
`Contact: Study Coordinator 936-525-2647
`[Recruiting]
`Desoto, Texas, United States, 75115
`Contact: Study Coordinator 972-283-6286
`[Recruiting]
`Irving, Texas, United States, 75062
`Contact: Study Coordinator 972-717-6262
`Costa Rica
`[Recruiting]
`San Jose, Costa Rica
`Contact: Study Coordinator 0115062585185
`Korea, Republic of
`[Recruiting]
`
`https://clinicaltrials.gov/ct2/history/NCT00111189?V_3=View#StudyPageTop
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`History of Changes for Study: NCT00111189
`Gwangju, Korea, Republic of, 501-757
`Contact: Study Coordinator 82622206143
`[Recruiting]
`Inchon, Korea, Republic of, 400-711
`Contact: Study Coordinator 83328903475
`[Recruiting]
`Pusan, Korea, Republic of, 614-735
`Contact: Study Coordinator 83518906189
`[Recruiting]
`Seoul, Korea, Republic of, 136-705
`Contact: Study Coordinator 8229205997
`[Recruiting]
`Seoul, Korea, Republic of, 143-711
`Contact: Study Coordinator 82222040338
`Romania
`[Recruiting]
`Bucharest, Romania, 030455
`Contact: Study Coordinator 0040723536339
`[Recruiting]
`Bucharest, Romania, 041914
`Contact: Study Coordinator 0040744586103
`[Recruiting]
`Bucharest, Romania, 050042
`Contact: Study Coordinator 0040723448106
`[Recruiting]
`Bucharest, Romania, 070622
`Contact: Study Coordinator 0040722227809
`[Recruiting]
`Cluj Napoca, Romania, 400012
`Contact: Study Coordinator 0040722796067
`[Recruiting]
`Iasi, Romania, 700282
`Contact: Study Coordinator 0040722465120
`[Recruiting]
`Sibiu, Romania, 550245
`Contact: Study Coordinator 0040745315592
`[Recruiting]
`Tg.Mures, Romania, 540139
`Contact: Study Coordinator 0040723536339
`[Recruiting]
`Timisoara, Romania, 300182
`Contact: Study Coordinator 0040721804861
`Russian Federation
`[Recruiting]
`Moscow, Russian Federation, 113152
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`https://clinicaltrials.gov/ct2/history/NCT00111189?V_3=View#StudyPageTop
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`History of Changes for Study: NCT00111189
`Contact: Study Coordinator 007 095 952 8331
`[Recruiting]
`Moscow, Russian Federation, 115522
`Contact: Study Coordinator 007 095 116 5183
`[Recruiting]
`Moscow, Russian Federation, 115522
`Contact: Study Coordinator 007 095 116 9083
`[Recruiting]
`Moscow, Russian Federation, 132367
`Contact: Study Coordinator 007 095 1931132
`[Recruiting]
`Samara, Russian Federation, 443016
`Contact: Study Coordinator 007 8462 511572
`[Recruiting]
`St Petersburg, Russian Federation, 193167
`Contact: Study Coordinator 007 812 274 1584
`[Recruiting]
`St. Petersburg, Russian Federation, 193019
`Contact: Study Coordinator 0078125677217
`[Recruiting]
`Yaroslavl, Russian Federation, 150003
`Contact: Study Coordinator 007 0852 735229
`South Africa, Gauteng
`[Recruiting]
`Pretoria, Gauteng, South Africa, 1709
`Contact: Study Coordinator 27 11 672 9411
`[Recruiting]
`Pretoria, Gauteng, South Africa
`Contact: Study Coordinator 27 12 664 0222
`South Africa
`[Recruiting]
`Cape Town, South Africa, 7530
`Contact: Study Coordinator 27 21 949 3378
`[Recruiting]
`Johannesburg, South Africa, 2021
`Contact: Study Coordinator 27 11 463 8132
`Taiwan
`[Recruiting]
`Changhua, Taiwan, 500
`Contact: Study Coordinator 88647299371
`[Recruiting]
`Jen-Te-County, Taiwan, 717
`Contact: Study Coordinator 88662703180
`[Recruiting]
`Kaohsiung, Taiwan, 807
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`History of Changes for Study: NCT00111189
`Contact: Study Coordinator 88673134761
`[Recruiting]
`Taoyuan, Taiwan, 330
`Contact: Study Coordinator 886933168692
`Ukraine
`[Recruiting]
`Dnepropetrovsk, Ukraine, 49115
`Contact: Study Coordinator 38 056 226 8656
`[Recruiting]
`Dnepropetrovsk, Ukraine, 49616
`Contact: Study Coordinator 38 056 247 1716
`[Recruiting]
`Kharkov, Ukraine, 61068
`Contact: Study Coordinator 38 057 226 3225
`[Recruiting]
`Kiev, Ukraine, 02660
`Contact: Study Coordinator 38 044 543 8730
`[Recruiting]
`Kiev, Ukraine, 04080
`Contact: Study Coordinator 38 044 468 5036
`[Recruiting]
`Lviv, Ukraine, 79021
`Contact: Study Coordinator 38 032 292 0650
`[Recruiting]
`Odessa, Ukraine, 65006
`Contact: Study Coordinator 38 048 230 2150
`[Recruiting]
`Simferopol, Ukraine, 95006
`Contact: Study Coordinator 38 065 227 6318
`
`IPDSharing
`
`References
`
`Plan to Share IPD:
`
`Citations: Emsley R, Nuamah I, Gopal S, Hough D, Fleischhacker WW. Relapse After
`Antipsychotic Discontinuation in Schizophrenia as a Withdrawal Phenomenon vs
`Illness Recurrence: A Post Hoc Analysis of a Randomized Placebo-Controlled Study. J
`Clin Psychiatry. 2018 Jun 19;79(4). pii: 17m11874. doi: 10.4088/JCP.17m11874.
`PubMed 29924507
`Weiden PJ, Kim E, Bermak J, Turkoz I, Gopal S, Berwaerts J. Does Half-Life Matter
`After Antipsychotic Discontinuation? A Relapse Comparison in Schizophrenia With 3
`Different Formulations of Paliperidone. J Clin Psychiatry. 2017 Jul;78(7):e813-e820.
`doi: 10.4088/JCP.16m11308. PubMed 28640988
`Kozma CM, Slaton T, Dirani R, Fastenau J, Gopal S, Hough D. Changes in
`schizophrenia-related hospitalization and ER use among patients receiving
`paliperidone palmitate: results from a clinical trial with a 52-week open-label extension
`(OLE). Curr Med Res Opin. 2011 Aug;27(8):1603-11. doi:
`10.1185/03007995.2011.595000. Epub 2011 Jun 22. PubMed 21696265
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`History of Changes for Study: NCT00111189
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`Hough D, Gopal S, Vijapurkar U, Lim P, Morozova M, Eerdekens M. Paliperidone
`palmitate maintenance treatment in delaying the time-to-relapse in patients with
`schizophrenia: a randomized, double-blind, placebo-controlled study. Schizophr Res.
`2010 Feb;116(2-3):107-17. doi: 10.1016/j.schres.2009.10.026. Epub 2009 Dec 2.
`PubMed 19959339
`
`Links:
`Available IPD/Information:
`
`Scroll up to access the controls
`
`Scroll to the Study top
`
`U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services
`
`https://clinicaltrials.gov/ct2/history/NCT00111189?V_3=View#StudyPageTop
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