Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia

Completed · Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT01515423

Run by

Janssen Research & Development, LLC

People needed

1429

Starts

2012-05-01

Expected to finish

2015-03-01

Last updated by the study team

2016-05-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — Glendale, California, United States
• Study site — Long Beach, California, United States
• Study site — Oakland, California, United States
• Study site — Oceanside, California, United States
• Study site — Orange, California, United States
• Study site — San Diego, California, United States
• Study site — New Britain, Connecticut, United States
• Study site — Bradenton, Florida, United States
• Study site — Kissimmee, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Wichita, Kansas, United States
• Study site — East Lansing, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Jamaica, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Canton, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Memphis, Tennessee, United States
• Study site — Austin, Texas, United States
• Study site — Bothell, Washington, United States
• Study site — Buenos Aires, Argentina
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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