Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia

Condition(s) targeted: Schizophrenia

Intervention: RISPERDAL CONSTA (Drug); Paliperidone palmitate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

The purpose of this study is to demonstrate the effectiveness of paliperidone palmitate 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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia

Secondary outcome:

The Change From Baseline for the CGI-S Score

The Change From Baseline in the PSP Score

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Linz, Austria

Salzburg, Austria

Wien, Austria

Plovdiv N/A, Bulgaria

Varna, Bulgaria

Brno 18, Czech Republic

Brno, Czech Republic

Dobrany N/A, Czech Republic

Kromeriz, Czech Republic

Kutna Hora, Czech Republic

Olomouc 9, Czech Republic

Praha 8, Czech Republic

Praha, Czech Republic

Pärnu N/A, Estonia

Tallinn, Estonia

Tartu N/A, Estonia

Bourges Cedex N/A, France

Dole Cedex, France

Romans Sur Isere Cedex, France

Achim, Germany

Berlin, Germany

Bielefeld, Germany

Bochum, Germany

Jena, Germany

Leipzig, Germany

Mannheim, Germany

München, Germany

Stralsund, Germany

Baja, Hungary

Budapest N/A, Hungary

Budapest, Hungary

Gyõr, Hungary

Kalocsa, Hungary

Nagykallo N/A, Hungary

Aurangabad, India

Bangalore, India

Chandigarh, India

Mangalore, India

Pune, India

Varanasi, India

Alytus, Lithuania

Kaunas, Lithuania

Klaipeda, Lithuania

Vilnius, Lithuania

Belchatow, Poland

Bytom Na, Poland

Chelmno, Poland

Gdynia Na, Poland

Katowice Woj Slaskie, Poland

Krakow Na, Poland

Lubliniec, Poland

Piekary Slaskie Na, Poland

Skorzewo Na, Poland

Warszawa Na, Poland

Moscow N/A, Russian Federation

Moscow Russia, Russian Federation

Nizny Novgorod, Russian Federation

Saratov N/A, Russian Federation

St Petersburg N/A, Russian Federation

St Petersburg, Russian Federation

St-Petersburg, Russian Federation

Yaroslavl, Russian Federation

Barcelona, Spain

Madrid, Spain

San Juan, Spain

Dnepropetrovsk, Ukraine

Donetsk, Ukraine

Kharkiv, Ukraine

Kiev, Ukraine

Kyiv, Ukraine

Odessa, Ukraine

Simferopol, Ukraine

Birmingham, Alabama, United States

Little Rock, Arkansas, United States

Cerritos, California, United States

Garden Grove, California, United States

Los Angeles, California, United States

Washington, 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

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

Starting date: March 2007
Last updated: June 11, 2014