Clinical trial NCT00589914: Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia
Official title: A Randomized, Double-Blind, Parallel-Group, Comparative Study of Flexible Doses of Paliperidone Palmitate and Flexible Doses of Risperidone Long-Acting Intramuscular Injection in Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
long-acting injectable antipsychotic medication
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2008-01-10
Enrollment: 1221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the effectiveness of paliperidone palmitate in patients with Schizophrenia.

Detailed description: This is a randomized (patients assigned to treatment groups by chance), double-blind (patient and study staff will not know the treatment assignment) study of paliperidone palmitate compared with RISPERDAL CONSTA (Risperidone Long-Acting Intramuscular Injection) in adult patients with schizophrenia. The total duration of the study will be approximately 14 weeks. For those patients without source documentation of tolerability to oral (by mouth) risperidone or paliperidone Extended Release (ER) tablets, injectable RISPERDAL CONSTA or paliperidone palmitate, or those patients who were not currently taking another antipsychotic, a minimum of 4 days and a maximum of 6 days of oral paliperidone ER treatment at a dosage of 6 mg/day will be administered for tolerability testing before the first injection of double-blind (DB) study drug (paliperidone palmitate or RISPERDAL CONSTA). During the DB period, study drug will be administered to patients as an intramuscular (i.m.) injection. Paliperidone palmitate (PP) 150mg equivalent (eq) (and RISPERDAL CONSTA placebo) at Baseline (BL) (Day 1), 100mg eq at Visit (V) 4 (Day 8), 50 or 100mg eq at V7 (Day 36), and 50,100,or 150mg eq at V9 (Day 64) or RISPERDAL CONSTA (RC) 25mg at V4 and V6 (Day 22), 25 or 37.5mg at V7, and 25, 37.5, or 50mg at V9 will be given as i.m. injections. Patients in the RC group will also take risperidone tablets (1-6 mg/day) at BL for 28 days and be given an injection of PP placebo at BL, V1, V7, and V9.

Eligibility criteria: Inclusion Criteria:

* Meet diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria as specified by the protocol for at least 1 year before screening
* Prior medical records, written documentation or verbal information obtained from previous psychiatric providers obtained by the investigator must be consistent with the diagnosis of schizophrenia
* A total PANSS score between 60 and 120, inclusive, at screening and baseline; Body mass index (BMI) at the screening visit BMI at least 17 kg/m2
* Female patients must be postmenopausal for at least 2 years, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before study entry and throughout the study as specified by the protocol. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (b hCG) pregnancy test result at screening.

Exclusion Criteria:

* Patient unable to provide consent or involuntarily committed to psychiatric hospitalization; A primary, active DSM-IV diagnosis on Axis I other than schizophrenia
* A DSM-IV diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
* History of treatment resistance as defined by failure to respond to 2 adequate treatments with different antipsychotic medications (an adequate treatment is defined as a minimum of 6 weeks at maximum tolerated dosage)
* Relevant history or current presence of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular disease), renal, hepatic, hematologic, endocrine, immunologic, or other systemic disease including history of neuroleptic malignant syndrome; History of any severe pre-existing gastrointestinal narrowing or inability to swallow oral study drug whole with the aid of water (applies to those patients requiring oral tolerability only)
* Significant risk of suicidal or violent behavior, as clinically assessed by the investigator ; History of life-threatening allergic reaction to any drug; Known or suspected hypersensitivity or intolerance to risperidone, paliperidone, 20% Intralipid, or any of their excipients (e.g., soybean oil, egg yolks, phospholipids, and glycerol)
* Have received an experimental drug or experimental biologic, or used an experimental medical device within 6 months before screening; History of any active malignancy within the previous 5 years, with the exception of basal cell carcinomas
* Women who are pregnant or breast-feeding or are planning to become pregnant uring the study

Primary outcomes:
measure: Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia
timeFrame: Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)
Secondary outcomes:
measure: The Change From Baseline for the CGI-S Score
timeFrame: Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)]
measure: The Change From Baseline in the PSP Score
timeFrame: Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Cerritos
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Flowood
country: United States
state: Mississippi
city: Hollis
country: United States
state: New York
city: Willoughby
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Desoto
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Odessa
country: United States
state: Texas
city: Linz
country: Austria
city: Salzburg
country: Austria
city: Wien
country: Austria
city: Plovdiv N/A
country: Bulgaria
city: Varna
country: Bulgaria
city: Brno 18
country: Czech Republic
city: Brno
country: Czech Republic
city: Dobrany N/A
country: Czech Republic
city: Kromeriz
country: Czech Republic
city: Kutna Hora
country: Czech Republic
city: Olomouc 9
country: Czech Republic
city: Praha 8
country: Czech Republic
city: Praha
country: Czech Republic
city: Pärnu N/A
country: Estonia
city: Tallinn
country: Estonia
city: Tartu N/A
country: Estonia
city: Bourges Cedex N/A
country: France
city: Dole Cedex
country: France
city: Romans Sur Isere Cedex
country: France
city: Achim
country: Germany
city: Berlin
country: Germany
city: Bielefeld
country: Germany
city: Bochum
country: Germany
city: Jena
country: Germany
city: Leipzig
country: Germany
city: Mannheim
country: Germany
city: München
country: Germany
city: Stralsund
country: Germany
city: Baja
country: Hungary
city: Budapest N/A
country: Hungary
city: Budapest
country: Hungary
city: Gyõr
country: Hungary
city: Kalocsa
country: Hungary
city: Nagykallo N/A
country: Hungary
city: Aurangabad
country: India
city: Bangalore
country: India
city: Chandigarh
country: India
city: Mangalore
country: India
city: Pune
country: India
city: Varanasi
country: India
city: Alytus
country: Lithuania
city: Kaunas
country: Lithuania
city: Klaipeda
country: Lithuania
city: Vilnius
country: Lithuania
city: Belchatow
country: Poland
city: Bytom Na
country: Poland
city: Chelmno
country: Poland
city: Gdynia Na
country: Poland
city: Katowice Woj Slaskie
country: Poland
city: Krakow Na
country: Poland
city: Lubliniec
country: Poland
city: Piekary Slaskie Na
country: Poland
city: Skorzewo Na
country: Poland
city: Warszawa Na
country: Poland
city: Moscow N/A
country: Russian Federation
city: Moscow Russia
country: Russian Federation
city: Nizny Novgorod
country: Russian Federation
city: Saratov N/A
country: Russian Federation
city: St Petersburg N/A
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St-Petersburg
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: San Juan
country: Spain
city: Dnepropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kiev
country: Ukraine
city: Kyiv
country: Ukraine
city: Odessa
country: Ukraine
city: Simferopol
country: Ukraine
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Alphs L, Bossie CA, Fu DJ, Ma YW, Kern Sliwa J. Onset and persistence of efficacy by symptom domain with long-acting injectable paliperidone palmitate in patients with schizophrenia. Expert Opin Pharmacother. 2014 May;15(7):1029-42. doi: 10.1517/14656566.2014.909409.
citation: Fu DJ, Bossie CA, Sliwa JK, Ma YW, Alphs L. Paliperidone palmitate versus oral risperidone and risperidone long-acting injection in patients with recently diagnosed schizophrenia: a tolerability and efficacy comparison. Int Clin Psychopharmacol. 2014 Jan;29(1):45-55. doi: 10.1097/YIC.0000000000000006.
citation: Fu DJ, Bossie CA, Kern Sliwa J, Ma YW, Alphs L. Paliperidone palmitate versus risperidone long-acting injection in markedly-to-severely ill schizophrenia subjects: onset of efficacy with recommended initiation regimens. Clin Schizophr Relat Psychoses. 2014 Jul;8(2):101-9, 109A. doi: 10.3371/CSRP.FUBO.022213.
citation: Pandina G, Lane R, Gopal S, Gassmann-Mayer C, Hough D, Remmerie B, Simpson G. A double-blind study of paliperidone palmitate and risperidone long-acting injectable in adults with schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2011 Jan 15;35(1):218-26. doi: 10.1016/j.pnpbp.2010.11.008. Epub 2010 Nov 16.