urasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia
- Conditions
- -F20F20
- Registration Number
- PER-052-08
- Lead Sponsor
- DAINIPPON SUMITOMO PHARMA AMERICA, INC,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• The patient agrees to participate by providing written informed consent. Note: If the patient refuses to give their consent for testing of genetic samples or granting additional optional interviews, this does not exclude them from participating in the study.
• The patient must be between 18 and 75 years of age inclusive, the day they sign the informed consent.
• The patient meets the DSM-IV criteria for a primary diagnosis of schizophrenia (including the subtypes disorganized (295.10), paranoid (285.30), or undifferentiated (295.90) as established in the clinical interview (using the Mini-international neuropsychiatric interview The duration of the patient´s illness, whether treated or not, must be longer than 1 year.
• The patient has an acute exacerbation of psychotic symptoms (no more than 2 months) and a marked deterioration in baseline function (according to background) or the patient has been hospitalized for the purpose of treating an acute psychotic exacerbation for 2 weeks consecutive or less immediately before the selection. Patients who have been hospitalized for more than 2 weeks for reasons unrelated to an acute exacerbation may be admitted with the approval of the Medical Monitor that such hospitalization was due to a reason that was not an acute relapse. For example, hospitalized for very long periods (for example, years) that present a clear acute exacerbation and are referred to an acute unit (for 2 weeks or less) are eligible for this protocol.
• The patient has a total PANSS score of> 80 in the selection and baseline, with a score of> 4 (moderate) in 2 or more of the following PANSS items: delusions, conceptual disorganization, hallucinations, content of unusual thinking and distrust.
• The patient presents a score> 4 in the CGI-S in the selection period and at the baseline level.
• The tests of the drugs of abuse selected give a negative result for the patient in the selection period and at the baseline level. In case a patient´s tests give a positive result for cannabinoid (tetrahydrocannabinol) or alcohol, the investigator will evaluate the possibility that the patient refrains from using prohibited substances during the study. If, in accordance with the clinical criteria of the investigator, the patient will abstain, he / she will be able to register after consulting with the Medical Monitor.
• The patient is not pregnant, (must have a negative pregnancy test in the selection period) or breastfeeding (should not be breastfeeding) and is not planning a pregnancy within the projected duration of the study .
• A potentially fertile patient (ie not surgically sterile or postmenopausal with at least 12 months of spontaneous amenorrhea or between 6 and 12 months of spontaneous amenorrhea with concentrations of follicle stimulating hormone (FSH) within the postmenopausal range determined by analysis laboratory) agrees to abstain or use an adequate and reliable contraceptive method throughout the study and, if the investigator determines, the patient will adhere to this requirement. The appropriate contraceptive method is defined as the continuous use of either double barrier (for example, condoms and spermicide or diaphragm and spermicide) or hormonal contraceptive methods in combination with at least one barrier method. Acceptable hormonal contraceptive methods include the following: a) contraceptive implant (such as Norplant®) placed at least 3 months before the wash
• The patient currently has a clinically significant neurological disorder, metabolic (including type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal and / or clinically significant urine such as unstable angina, congestive heart failure (uncontrolled), infection in the central nervous system (CNS), or a history of seropositivity of the human immunodeficiency virus that would put the patient at risk if he participated in the study or that could confuse the results of the study.
• 2- The patient presents evidence of acute hepatitis, clinically significant chronic hepatitis, or deterioration of liver function in clinically significant form through a clinical and laboratory evaluation.
• The estimated creatinine clearance of the patient is <60 mL / min,
• The patient has a history of stomach or intestinal surgery or some other condition that could interfere with the absorption, distribution, metabolism or excretion of medications.
• The patient has a history of malignancies <5 years before signing the informed consent, with the exception of basal cell cancer or squamous cell skin cancer or cervical cancer in situ treated appropriately. Pituitary tumors of any duration are excluded.
• The patient presents evidence of a chronic organic disease of the CNS (apart from schizophrenia) such as tumors, inflammation, active seizure disorder, vascular disorder, Parkinson´s disease, Alzheimer´s disease or other forms of dementia, myasthenia gravis or other degenerative processes. In addition, patients should not have a history of mental retardation or persistent neurological symptoms attributable to a serious head injury. The history of febrile attacks, attacks provoked by drugs, or attacks for abstinence from alcohol are not grounds for exclusion.
• The patient has a history of neuroleptic malignant syndrome (NMS).
• The patient presents evidence of severe tardive dyskinesia, severe dystonia or any other serious movement disorder. The severity will be determined by the investigator.
• The investigator considers that the patient is at imminent risk of committing suicide, damaging himself, harming other people or objects.
• The patient has a clinically significant history of alcohol / alcohol abuse or drug abuse / dependence within the past 6 months. Exceptions include abuse / dependence on caffeine or nicotine.
• The patient has a history of macular disease or retinitis pigmentosa.
• The patient has some abnormal laboratory parameter (except glucose or glycosylated hemoglobin [HbA1c]) that indicates a clinically significant medical condition determined by the investigator.
• The patient has prolactin concentrations of more than 200ng / mL in the selection period or has a history of pituitary adenoma.
• The patient has a history or presence of abnormal electrocardiogram (ECG) that, according to the researcher, is clinically significant.
• The patient has a muscle mass index (BMI) greater than 40 or less than 18.5 kg / m2
• The patient presents, according to the opinion of the study center team, poor peripheral venous accesses.
• The patient has a history of hypersensitivity to more than 2 different types of chemical drugs (for example, sulfa drugs and penicillins).
• The patient has a history of hypersensitivity to olanzapine.
• The patient has used olanzapine within 30 days prior to the Screening period and / or has had an inadequate r
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method