The purpose of this study is to evaluate the safety and tolerability of intramuscular injections (to the buttocks or to the shoulders) of paliperidone palmitate in patients with schizophrenia.

Condition	Intervention	Phase
Schizophrenia	Drug: Paliperidone palmitate	Phase III

Further Study Details: 

Primary Outcomes: Safety evaluation (e.g. incidence of adverse events) between start and finish of the trial
Secondary Outcomes: Pharmacokinetic evaluations (e.g. blood level of the drug) at finish of trial; Efficacy measures at finish of trial

To date, all prior trials involving intramuscular injection of paliperidone palmitate were conducted with buttock administration. This is a randomized, multicenter, crossover design study in evaluating safety and tolerability of paliperidone palmitate in two different injection sites. The study hypothesis is that there will be no difference in safety and tolerability between buttock injection compared to shoulder injection at any of the three different doses of paliperidone palmitate.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• The patient must have signed an informed consent
• The patient must meet the diagnostic criteria for schizophrenia
• Female patient must be postmenopausal for at least 2 years or have negative pregnancy test result at screening
• The patient must be able to perform study requirements (e.g. answer questionnaire)

Exclusion Criteria:

• Primary, active diagnosis other than schizophrenia
• Psychiatric inpatient hospitalization for relapse of symptoms of schizophrenia in the past 90 days
• Change in antipsychotic medication in the past 45 days
• Diagnosis of active substance dependence within 3 months
• History of treatment resistance
• History of concurrent significant or unstable diseases (e.g. heart, lung, or liver diseases)

Please refer to this study by ClinicalTrials.gov identifier  NCT00119756

Study ID Numbers:  CR002350
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 14, 2005
ClinicalTrials.gov Identifier:  NCT00119756
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26