A Safety and Tolerability Study of Paliperidone Palmitate Injected in the Shoulder or the Buttock Muscle in Patients With Schizophrenia

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The patients will receive intramuscular injections of paliperidone palmitate in either their buttocks or in their shoulders

Official Title
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A Randomized, Crossover Study to Evaluate the Overall Safety and Tolerability of Paliperidone Palmitate Injected in the Deltoid or Gluteus Muscle in Patients With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: paliperidone palmitate


Participation Criteria
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Eligibility Criteria
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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 their 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: paliperidone palmitate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety evaluation (e.g. incidence of adverse events) between start and finish of the trial |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic evaluations (e.g. blood level of the drug) at finish of trial; Efficacy measures at finish of trial |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Intramuscular injection, Deltoid muscle, Gluteus muscle, Paliperidone palmitate