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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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Iloperidone, Iloperidone, Iloperidone, Iloperidone, Iloperidone, Iloperidone, Iloperidone
Novartis Investigative Site
Published on BioPortfolio: 2014-08-27T04:00:24-0400
Tolerability, undertstanding of the action of the drug in the body, and understanding the effect of the drug in adolescent patients needing treatment with an antipsychotic medication
The purpose of this study is to determine the safety and efficacy of iloperidone compared to placebo and an active comparator in the treatment of patients with schizophrenia in acute exace...
to inspect relevant pharmacokinetic parameters and relative exploitation degree, with fasting and postprandial dosing bioequivalence test under the condition of the human body, provide the...
The purpose of this pilot randomized clinical trial is to begin to delineate the pathophysiological changes associated with antipsychotic associated metabolic side effects. The study will ...
The primary purpose of this study is to evaluate the overall effect of caregivers receiving a study-provided caregiver psycho-education and skills training program on the number of treatme...
Schizophrenia is associated with increased physical morbidity and early mortality, suggesting that the aging process may be accelerated in schizophrenia. However, the biological underpinnings of these...
The neurodevelopmental hypothesis of schizophrenia has become a paradigm broadly accepted in today's research in schizophrenia and its spectrum. This article traces the historical development of the n...
Schizophrenia is a common disease with a high risk of comorbidity in both psychiatric and somatic diseases. Physical activity is proven effective in reducing symptoms of schizophrenia and increasing o...
Emotion deficits may be the basis of negative symptoms in schizophrenia patients and they are prevalent in these patients. However, inconsistent findings about emotion deficits in schizophrenia sugges...
ECT remains an important, yet underutilized, treatment for schizophrenia. Recent research shows that medication-resistant patients with schizophrenia, including those resistant to clozapine, respond w...
A chronic form of schizophrenia characterized primarily by the presence of persecutory or grandiose delusions, often associated with hallucination.
A type of schizophrenia characterized by abnormality of motor behavior which may involve particular forms of stupor, rigidity, excitement or inappropriate posture.
An obsolete concept, historically used for childhood mental disorders thought to be a form of schizophrenia.
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)
An antipsychotic agent used in schizophrenia.
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...
Psychiatry is the study of mental disorders and their diagnosis, management and prevention. Conditions include schizophrenia, severe depression and panic disorders among others. There are pharmaceutical treatments as well as other therapies to help...
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