Schizophrenia
Conditions
Keywords
Schizophrenia, Acutely Psychotic Patients with Schizophrenia, Latuda, Lurasidone
Brief summary
This is a study designed to evaluate the efficacy and safety of lurasidone in acutely psychotic patients with chronic schizophrenia and to confirm the non-inferiority of lurasidone relative to quetiapine XR.
Interventions
DRUGLurasidone HCL 160 mg
Lurasidone HCL 2 80mg tablets, QD
DRUGQuetiapine XR 600 mg
Quetiapine XR 2 300 mg tablets, QD
Sponsors
Bukwang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Provide written informed consent and aged between 19 and 75 years of age. 2. Meets DSM-5 criteria for a primary diagnosis of schizophrenia. 3. CGI-S ≥ 4 at screening and baseline. 4. Subject 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. 5. Subject is able and agrees to remain off prior antipsychotic medication for the duration of the study. 6. Subject is in good physical health on the basis of medical history, physical examination, and laboratory screening.
Exclusion criteria
1. The subject has evidence of any chronic organic disease of the CNS (other than schizophrenia) 2. Subject has participated in a prior trial of lurasidone. 3. Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months. 4. In the opinion of the investigator, subject is unable to cooperate with any study procedures, unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study. 5. Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in Total PANSS Score From Baseline at Week 6 | Week 6 | The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in CGI-S score From Baseline at Week 6 | Week 6 | Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill). |
Countries
South Korea
Outcome results
None listed