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Rio Piedras |
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State:
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| Conditions: |
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Schizophrenia |
| Purpose: |
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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 were recently released from jail.
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| Study summary: |
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The primary objective of this study is to compare the efficacy of paliperidone palmitate
with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure
over 15 months, in patients diagnosed with schizophrenia who were recently released from
jail. Protocol-defined treatment failure is defined as arrest, psychiatric hospitalization,
increase in psychiatric services to prevent imminent hospitalization, discontinuation of
antipsychotic treatment due to inadequate efficacy, treatment supplementation with another
antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to
safety or tolerability or completed suicide. Protocol was amended on July 2, 2010 to
reflect changes in the inclusion/exclusion criteria as well as the study objectives.
Patients will receive either paliperidone palmitate 78, 117, 156, or 234 mg monthly by
injection for fifteen months OR oral aripiprazole, haloperidol, olanzapine, paliperidone,
perphenazine, quetiapine, and risperidone at doses selected by the study doctor. |
| Criteria: |
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Inclusion Criteria:
- 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 1 oral antipsychotic on the day before randomization
- Have had at least 2 arrests with incarceration within the 24 months previous to study
start, with the last release occurring within the 60 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
Exclusion Criteria:
- 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 |
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| Study is available at: |
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Rio Piedras,
Puerto Rico
Primary Contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:
Email: info1@veritasmedicine.com |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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