A Phase 3 Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Efficacy of Three Doses of Lurasidone HCl in Acutely Psychotic Patients with Schizophrenia
- Conditions
- SchizophreniaMedDRA version: 9.1Level: LLTClassification code 10039626Term: Schizophrenia
- Registration Number
- EUCTR2007-003819-31-FR
- Lead Sponsor
- Dainippon Sumitomo Pharma America, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 480
1. Patient agrees to participate by providing written informed consent.
2. Patient is between 18 and 75 years of age inclusive on the day of signing informed consent.
3. Patient meets DSM-IV™ criteria for a primary diagnosis of schizophrenia (including disorganized (295.10), paranoid (295.30), and undifferentiated (295.90) subtypes as established by clinical interview (using the Mini-International Neuropsychiatric Interview [MINI] Plus diagnostic interview). The duration of the patient’s illness, whether treated or untreated, must be greater than 1 year.
4. Patient has an acute exacerbation of psychotic symptoms (no longer than 2 months) and marked deterioration of function from baseline (by history) or patient has been hospitalized for the purpose of treating an acute psychotic exacerbation for 2 consecutive weeks or less immediately before screening. Patients who have been hospitalized for more than 2 weeks for reasons unrelated to acute exacerbation can be included with concurrence from the Medical Monitor that such hospitalisation was for a reason other than acute relapse.
5. Patient has a PANSS total score =80 at screening and baseline, with a score =4 (moderate) on 2 or more on the following PANSS items: delusions, conceptual disorganization, hallucinations, unusual thought content, and suspiciousness.
6. Patient has a score =4 on the CGI-S at screening and baseline.
7. Patient tests negative for selected drugs of abuse at screening and baseline.
8. Patient is not pregnant (must have a negative serum pregnancy test at screening) or nursing (must not be lactating) and is not planning pregnancy within the projected duration of the study.
9. A patient who is of reproductive potential (i.e., not surgically sterile or postmenopausal defined as at least 12 months of spontaneous amenorrhea or between 6 and 12 months spontaneous amenorrhea with follicle stimulating hormone (FSH) concentrations within postmenopausal range as determined by laboratory analysis) agrees to remain abstinent or use adequate and reliable contraception throughout the study, and in the investigator’s judgment, the patient will adhere to this requirement.
Adequate contraception is defined as continuous use of either 2 barrier methods (e.g., condom and spermicide or diaphragm with spermicide) or hormonal contraceptives. Hormonal contraceptives may be permitted after the completion of a drug interaction study. Hormonal contraceptives include the following: a) contraceptive implant (such as Norplant®) inserted at least 3 months prior to washout; b) injectable contraception (such as Medroxyprogesterone acetate injection) given at least 14 days prior to washout; or c) oral contraception taken as directed for at least 1 month prior to washout.
10. Patient is able and agrees to remain off prior antipsychotic medication for the duration of the study.
11. Patient has had a stable living arrangement for at least 3 months prior to randomization and agrees to return to a similar living arrangement after discharge.
12. Patient is in good physical health on the basis of medical history, physical examination, and laboratory screening.
13. Patient is willing and able to comply with the protocol, including the inpatient requirements and outpatient visits, in the opinion of the study nurse/coordinator and the investigator.
14. Patients who require concomitant medication treatment with the following agents may be included if they have been on stable doses for the specified times: 1
1.Patient currently has a clinically significant neurological, metabolic (including type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorder such as unstable angina, congestive heart failure (uncontrolled), central nervous system (CNS) infection, or history of human immunodeficiency virus (HIV) seropositivity that would pose a risk to the patient if they were to participate in the study or that might confound the results of the study.
2. The patient has evidence of acute hepatitis, clinically significant chronic hepatitis, or evidence of clinically significant impaired hepatic function through clinical and laboratory evaluation.
3. Patient’s estimated creatinine clearance is <60 mL/min,
4. Patient has a history of stomach or intestinal surgery that could interfere with absorption, distribution, metabolism, or excretion of medications.
5. Patient has a history of malignancy <5 years prior to signing the informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Pituitary tumors of any duration are excluded.
6. The patient has evidence of any chronic organic disease of the CNS (other than 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 must not have a history of mental retardation or persistent neurological symptoms attributable to serious head injury. Past history of febrile seizure, drug-induced seizure, or alcohol withdrawal seizure is not exclusionary.
7. Patient has a history of neuroleptic malignant syndrome (NMS).
8. Patient exhibits evidence of severe tardive dyskinesia, severe chronic tardive dystonia, or any other severe chronic movement disorder. Severity is to be determined by the investigator.
9. Patient is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
10. Patient has current clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months. Exceptions include caffeine or nicotine abuse/dependence.
11. Patient has a history of macular or retinal pigmentary disease.
12. Patient has any abnormal laboratory parameter (with the exception of glucose or HbA1c) that indicates a clinically significant medical condition as determined by the investigator.
13. Patient has a prolactin concentration of more than 200 ng/mL at screening or has a history of pituitary adenoma.
14. Patient has a history or presence of abnormal electrocardiogram (ECG), which in the investigator’s opinion is clinically significant.
15. Patient has a BMI greater than 40 kg/m2 or less than 18.5 kg/m2.
16. Patient has, in the opinion of the study site staff, poor peripheral venous access.
17. Patient has a history of hypersensitivity to more than 2 distinct chemical classes of drug (e.g., sulfas and penicillins).
18. Patient is resistant to neuroleptic treatment, defined as failure to respond to 2 or more marketed antipsychotic agents from 2 different classes, given at an adequate dose for a sufficient period of time over the last 1 year.
19. Patient has a history of treatment with clozapine for refractory psychosis and/or patient has been treated with clozapine within 4 months of randomization.
20. Patient has received depot neuroleptics unless the last inje
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method