Schizophrenia MedDRA version: 9.1 Level: LLT Classification code 10039626 Term: Schizophrenia
Conditions
Interventions
Product Name: lurasidone
Product Code: SM-13946
Pharmaceutical Form: Over encapsulated tablet
INN or Proposed INN: lurasidone
CAS Number: 367514-88-3
Current Sponsor code: SM-13496
Concentration uni
Sponsors
Dainippon Sumitomo Pharma America Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject is 18 to 75 years of age on the day of signing informed consent. Subject meets DSM-IV-TR criteria for a primary diagnosis of schizophrenia (including disorganized (295.10), paranoid (295.30), or undifferentiated (295.90) subtypes as established by clinical interview (using the Mini-International Neuropsychiatric Interview [MINI] Plus diagnostic interview and the DSM-IV-TR as a reference). The duration of the subject’s illness whether treated or untreated must be greater than 1 year. Subject has an acute exacerbation of psychotic symptoms (no longer than 2 months) and marked deterioration of function from baseline (by history) or subject has been hospitalized for the purpose of treating an acute psychotic exacerbation for 2 consecutive weeks or less immediately before screening. Subject has a PANSS total score =80 at screening and baseline, with a score =4 (moderate) on 2 or more of the following PANSS items: delusions, conceptual disorganization, hallucinations, and unusual thought content. Subject has a score =4 on the CGI-S at screening and baseline. Subject is able and agrees to remain off prior antipsychotic medication for the duration of the study. Subject has had a stable living arrangement for at least 3 months prior to randomisation and agrees to return to similar living arrangement after discharge. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subject is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property. Subject has a prolactin concentration >100 ng/mL at screening or has a history of pituitary adenoma. Subject has a history of hypersensitivity to quetiapine. Subject has used quetiapine within 30 days prior to Screening and/or has a history of inadequate response or intolerability to quetiapine. Subject 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 at least 6 weeks. Subject has received depot neuroleptics unless the last injection was at least 1 treatment cycle before randomization. Subject has a history of treatment with clozapine for refractory psychosis and/or subject has been treated with clozapine (for any reason) within 4 months of randomization. Subject has received treatment with mood stabilizers or antidepressants within 1 week, fluoxetine hydrochloride at any time within 1 month, or a monoamine oxidase (MAO) inhibitor with 3 weeks of randomization. Subject will require treatment with any potent cytochrome P450 3A4 (CYP3A4) inhibitors or inducers during the study. Subject requires treatment with a drug that prolongs the QT interval corrected for individual heart rate (QTc interval). The subject demonstrates a decrease (improvement) of >20% in the PANSS score between the screening and baseline visits, or the PANSS score falls below 80 at baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of lurasidone (80 mg/day and 160 mg/day) compared with placebo in subjects with acute schizophrenia (diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 4th Ed., Text Revision [DSM-IV-TR] criteria) as measured by the mean change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at endpoint (Week 6).;Primary end point(s): Mean change from baseline in total PANSS score at Week 6 ;Secondary Objective: To evaluate the efficacy of lurasidone compared with placebo as measured by the mean change from baseline in the CGI-S at Week 6 To evaluate the efficacy of lurasidone compared with placebo as measured by the mean change from baseline in PANSS total score on Day 4 To evaluate the efficacy of lurasidone compared with placebo in improving associated depressive symptoms as measured by the mean change from baseline in MADRS at Week 6 To evaluate the efficacy of lurasidone compared with quetiapine XR in the treatment of mpaired cognition associated with schizophrenia atWeek 6 To evaluate the efficacy of quetiapine XR compared with placebo as measured by the mean change from baseline in PANSS total score at Week 6 To evaluate the safety and tolerability of lurasidone as measured by the proportions of subjects with AEs, discontinuations due to AEs, and SAEs To confirm the tolerability and safety of lurasidone initiation at both 80 mg/day and 120 mg/day doses | — |
Countries
Romania
Outcome results
None listed