Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia

NCT ID: NCT00589914

Last Updated: 2014-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1221 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2009-06-30

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

RISPERDAL CONSTA

RISPERDAL CONSTA 25-50 mg eq every 2 weeks

Group Type: ACTIVE_COMPARATOR

RISPERDAL CONSTA

Intervention Type: DRUG

RISPERDAL CONSTA: Type=exact number, unit=mg, number=25, 37.5, or 50, form=suspension for injection, route=Intramuscular use. One i.m. injection of RISPERDAL CONSTA 25-50 mg eq every 2 weeks at V4, V6, V7, V8, V9, and V10. PALIPERIDONE PALMITATE PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 2 weeks at Baseline and at V4, V7, and V9. RISPERIDONE: Type=up to, unit=mg, number=1 to 6, form=Tablet, route=Oral Use. One tablet for the first 4 weeks (28 days) of the DB treatment period.

R092670

Paliperidone Palmitate 50-150 mg eq every 4 wks

Group Type: EXPERIMENTAL

Paliperidone palmitate

Intervention Type: DRUG

PALIPERIDONE PALMITATE: Type=exact number, unit=mg, number=50, 100, or 150, form=suspension for injection, route=Intramuscular use. One i.m. injection of Paliperidone palmitate 50-150 mg eq every 4 wks at Baseline, V4, V7, and V9. RISPERDAL CONSTA PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 4 weeks at Baseline, V4, V7, and V9.

Interventions

RISPERDAL CONSTA

RISPERDAL CONSTA: Type=exact number, unit=mg, number=25, 37.5, or 50, form=suspension for injection, route=Intramuscular use. One i.m. injection of RISPERDAL CONSTA 25-50 mg eq every 2 weeks at V4, V6, V7, V8, V9, and V10. PALIPERIDONE PALMITATE PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 2 weeks at Baseline and at V4, V7, and V9. RISPERIDONE: Type=up to, unit=mg, number=1 to 6, form=Tablet, route=Oral Use. One tablet for the first 4 weeks (28 days) of the DB treatment period.

Intervention Type: DRUG

Paliperidone palmitate

PALIPERIDONE PALMITATE: Type=exact number, unit=mg, number=50, 100, or 150, form=suspension for injection, route=Intramuscular use. One i.m. injection of Paliperidone palmitate 50-150 mg eq every 4 wks at Baseline, V4, V7, and V9. RISPERDAL CONSTA PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 4 weeks at Baseline, V4, V7, and V9.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

Birmingham, Alabama, United States

Little Rock, Arkansas, United States

Cerritos, California, United States

Garden Grove, California, United States

Los Angeles, California, United States

Washington D.C., District of Columbia, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Flowood, Mississippi, United States

Hollis, New York, United States

Willoughby, Ohio, United States

Oklahoma City, Oklahoma, United States

DeSoto, Texas, United States

Houston, Texas, United States

Odessa, Texas, United States

Linz, , Austria

Salzburg, , Austria

Vienna, , Austria

Plovdiv, , Bulgaria

Varna, , Bulgaria

Brno, , Czechia

Dobřany, , Czechia

Kroměříž, , Czechia

Kutná Hora, , Czechia

Olomouc, , Czechia

Prague, , Czechia

Pärnu, , Estonia

Tallinn, , Estonia

Tartu, , Estonia

Bourges Cedex N/A, , France

Dole, , France

Romans-sur-Isère, , France

Achim, , Germany

Berlin, , Germany

Bielefeld, , Germany

Bochum, , Germany

Jena, , Germany

Leipzig, , Germany

Mannheim, , Germany

München, , Germany

Stralsund, , Germany

Baja, , Hungary

Budapest, , Hungary

Gyõr, , Hungary

Kalocsa, , Hungary

Nagykálló, , Hungary

Aurangabad, , India

Bangalore, , India

Chandigarh, , India

Mangalore, , India

Pune, , India

Varanasi, , India

Alytus, , Lithuania

Kaunas, , Lithuania

Klaipėda, , Lithuania

Vilnius, , Lithuania

Bełchatów, , Poland

Bytom Na, , Poland

Chełmno, , Poland

Gdynia Na, , Poland

Katowice Woj Slaskie, , Poland

Krakow Na, , Poland

Lubliniec, , Poland

Piekary Slaskie Na, , Poland

Skorzewo Na, , Poland

Warszawa Na, , Poland

Moscow, , Russia

Moscow Russia, , Russia

Nizny Novgorod, , Russia

Saint Petersburg, , Russia

Saratov, , Russia

Yaroslavl, , Russia

Barcelona, , Spain

Madrid, , Spain

San Juan, , Spain

Dnipro, , Ukraine

Donetsk, , Ukraine

Kharkiv, , Ukraine

Kiev, , Ukraine

Kyiv, , Ukraine

Odesa, , Ukraine

Simferopol, , Ukraine

Countries

United States; Austria; Bulgaria; Czechia; Estonia; France; Germany; Hungary; India; Lithuania; Poland; Russia; Spain; Ukraine

References

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.

Reference Type: DERIVED

PMID: 24754314 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24113628 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23446197 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21092748 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=744&filename=CR012289_CSR.pdf

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

Other Identifiers

R092670PSY3006

Identifier Type: OTHER

Identifier Source: secondary_id

CR012289

Identifier Type: -

Identifier Source: org_study_id