15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated

Completed · Phase 4

Conditions studied: Schizophrenia

In brief

The study will assess the use of paliperidone palmitate compared with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 15 months, in patients diagnosed with schizophrenia who have been incarcerated.

Key facts

Study ID

NCT01157351

Run by

Janssen Scientific Affairs, LLC

People needed

450

Starts

2010-05-01

Expected to finish

2013-12-01

Last updated by the study team

2015-04-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be able to understand and sign the informed consent form approved by the Institutional Review Board (IRB)
• Must successfully answer all the questions on the Informed Consent quiz indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
• Have a current diagnosis of schizophrenia
• Taking no more than 1 oral antipsychotic on the day before randomization
• Have been placed into custody at least twice with one of them leading to incarceration within the 24 months previous to study start, with the last release occurring within the 90 days before the first day of screening
• in the opinion of the investigator, may benefit from a change in their prior antipsychotic treatment
• Have available a designated individual (eg, family member, case manager, significant other, probation/parole officer) who has knowledge of the patient and is generally aware of the patient's daily activities, and who agrees to let the study site personnel know of changes in the patients circumstances when the patient is not able to provide this information, ie, arrests, protocol-defined hospitalizations, emergency room visits, becoming homeless, etc.
• Have either an address or phone number where they can be reached, or be accessible to the designated individual
• Must agree to receive regular injections for 15 months if randomly assigned to the paliperidone palmitate treatment group, or continue with oral study medication treatment for 15 months if randomly assigned to the oral antipsychotic treatment group
• Women must be postmenopausal (for at least 2 years), surgically sterile (hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent, or if sexually active, be practicing a highly effective method of birth control

You may not qualify if…

• Allergies, hypersensitivity (anaphylaxis-type reaction), or intolerance to risperidone or paliperidone
• Actively abusing intravenous drugs within the past 3 months or have an opiate dependence disorder
• Have a positive urine drug screen test for barbiturates, cocaine, amphetamines, or opiates at screening
• Women who are pregnant or breast-feeding, or planning to become pregnant
• Have received injectable antipsychotic treatment within 2 injection cycles prior to screening
• Received treatment with clozapine within 3 months of screening
• Are at a high risk of violence in the next 15 months, in the opinion of the investigator
• who have a history of sex offenses including felony sex offenses, child molestation

Where it is running

• Study site — Tuscon, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Escondido, California, United States
• Study site — Glendale, California, United States
• Study site — Imperial, California, United States
• Study site — Long Beach, California, United States
• Study site — National City, California, United States
• Study site — Oakland, California, United States
• Study site — Oceanside, California, United States
• Study site — Pico Rivera, California, United States
• Study site — Riverside, California, United States
• Study site — San Bernadino, California, United States
• Study site — San Diego, California, United States
• Study site — San Fran Cisco, California, United States
• Study site — New Britain, Connecticut, United States
• Study site — New London, Connecticut, United States
• Study site — Leesburg, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami Gardens, Florida, United States
• Study site — Pensacola, Florida, United States
• Study site — Tamarac, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Bullhead City, Arizona, United States

Full record on ClinicalTrials.gov

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