Safety, Tolerability and Pharmacokinetics of Iloperidone Depot in Schizophrenic Patients
Summary
This study is designed as a three-part trial to evaluate the safety of a novel depot formulation of iloperidone, compare two depot dosage forms, and perform dose ranging of one chosen form in support of a monthly depot dosing regimen. In Phase A, the study is designed to evaluate the safety of a crystalline iloperidone depot formulation. In Phase B, the pharmacokinetic and safety profile of two depot clinical dosage forms will be compared, and one form will be selected for assessment in Phase C. Phase C of this study is designed to define the dose-exposure relationship of the selected form and to provide information that will permit a comparison of the risk-benefit ratio of several doses of the study drug to enable optimal dose selection for later studies.
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Schizophrenia
Intervention
Iloperidone, Iloperidone, Iloperidone, Iloperidone, Iloperidone, Iloperidone, Iloperidone
Location
Novartis Investigative Site
Glendale
California
United States
91206
Status
Completed
Source
Novartis
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01348100
- Information obtained from ClinicalTrials.gov on April 11, 2013
Medical and Biotech [MESH] Definitions
Schizophrenia, Paranoid
A chronic form of schizophrenia characterized primarily by the presence of persecutory or grandiose delusions, often associated with hallucination.
Schizophrenia, Catatonic
A type of schizophrenia characterized by abnormality of motor behavior which may involve particular forms of stupor, rigidity, excitement or inappropriate posture.
Schizophrenia, Childhood
An obsolete concept, historically used for childhood mental disorders thought to be a form of schizophrenia.
Schizophrenia, Disorganized
A type of schizophrenia characterized by frequent incoherence; marked loosening of associations, or grossly disorganized behavior and flat or grossly inappropriate affect that does not meet the criteria for the catatonic type; associated features include extreme social withdrawal, grimacing, mannerisms, mirror gazing, inappropriate giggling, and other odd behavior. (Dorland, 27th ed)
Butaclamol
A benzocycloheptapyridoisoquinolinol that has been used as an antipsychotic, especially in schizophrenia.
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