A Study of Paliperidone Palmitate 3 Month Formulation 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 evaluate the efficacy of paliperidone palmitate 3 month formulation (PP3M) compared with placebo in delay of the time to first occurrence of relapse of the symptoms of schizophrenia.

Key facts

Study ID

NCT01529515

Run by

Janssen Research & Development, LLC

People needed

509

Starts

2012-05-01

Expected to finish

2014-04-01

Last updated by the study team

2016-05-11

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
• A total score in the Positive and Negative Syndrome Scale (PANSS) < 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) Exclusion Criteria:
• 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 — San Fran Cisco, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Lauderhill, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Hoffman Estates, Illinois, United States
• Study site — Topeka, Kansas, United States
• Study site — Baltimore, Maryland, United States
• Study site — Flowood, Mississippi, United States
• Study site — Marlton, New Jersey, United States
• Study site — Cedarhurst, New York, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Austin, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Barranquilla, Colombia
• Study site — Bogotá, Colombia
• Study site — Medellín, Colombia
• Study site — Pereira, Colombia
• Study site — Johor Bahru, Malaysia
• Study site — Kuala Lumpur, Malaysia
• Study site — Tanjong Rambutan, Malaysia
• Study site — Guadajalara, Mexico
• Study site — Mexico City, Mexico
• Study site — Monterrey, Mexico
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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