| City: |
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Richmond |
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State:
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VA |
| Zip Code: |
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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 risperidone in
delaying time to relapse in patients recently diagnosed with schizophrenia who are at high
risk of relapse.
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| Study summary: |
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This is a Prospective, Randomized, Active-controlled, Rater-blinded Study to to assess the
efficacy of paliperidone palmitate compared with oral risperidone in delaying time to
relapse in patients recently diagnosed with schizophrenia who are at high risk of relapse.
Recently diagnosed is defined as first diagnosis of any psychotic disorder within 5 years
prior to screening. High risk of relapse is defined as having documented occurrence of 3
periods of breakthrough symptoms that required a change in patient care per the
investigator's judgment (e.g., increase in dose, addition of a new drug, increase in the
level of psychiatric care, notable increases in the frequency or intensity of patient
contact required to maintain outpatient status, psychiatric hospitalization, etc.) within
the previous 24 months, including 1 such period within the previous 6 months. Safety
evaluations will include AE reporting, labs, vital signs, ECG, and evaluations of
suicidality and sexual functioning. Patients will receive either paliperidone palmitate 50,
75, 100, or 150 mg eq. monthly by injection for two years or oral risperidone 2, 4, 6, or 8
mg tabs once daily for two years. |
| Criteria: |
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Inclusion Criteria:
- Patients must be, in the opinion of the investigator, able to understand the informed
consent form approved by the Institutional Review Board (IRB) or Independent Ethics
Committee (IEC), as appropriate
- All patients must sign the study informed consent document indicating that they
understand the purpose of and procedures required for the study and are willing to
participate in the study
- Must have a current diagnosis of schizophrenia
- must have had 3 periods of breakthrough symptoms that required a change in patient
care as determined by the investigator (e.g. increase in dose, addition of a new
drug, hospitalization, increase in the level of psychiatric care, notable increases
in the frequency or intensity of patient contact required to maintain outpatient
status, etc.) within the previous 24 months, including 1 such period within the
previous 6 months
- Women must be postmenopausal, surgically sterile, or otherwise be incapable of
pregnancy, abstinent, or if sexually active, be practicing a highly effective method
of birth control before entry, and must agree to continue to use the same method of
contraception throughout the study
- Women of childbearing potential must have a negative urine pregnancy test at
screening
- Patients must be cooperative and reliable, agree to receive regular injections, and
be willing/able to adhere to the prohibitions and restrictions specified in this
protocol
Exclusion Criteria:
- Patients who are unable to provide their own consent or are involuntarily committed
to psychiatric hospitalization
- Have attempted suicide within 12 months before screening or are at imminent risk of
suicide or violent behavior
- Have a positive urine drug screen test for barbiturates, cocaine, amphetamines, or
opiates at screening
- Patients who are in their first episode of psychosis
- Patients currently meeting criteria for any other Axis I diagnosis except substance
abuse or an Axis II diagnosis of Mental Retardation or Borderline Personality
Disorder
- Meet the DSM-IV definition of substance dependence (except for nicotine and caffeine
dependence) within 6-months prior to entry
- Patients with known allergies, hypersensitivity (anaphylaxis-type reaction), or
intolerance to paliperidone palmitate, risperidone, Risperdal®, Risperdal® Consta®,
or INVEGA® or its excipients
- Patients who received Long Acting Therapy (LAT) treatment within 2 injection cycles
prior to screening
- Women who are pregnant or breast-feeding, or planning to become pregnant |
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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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April 13, 2010 |
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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