A 6-Week, Double-Blind, Randomized, Fixed-Dose, Parallel-Group Study of the Efficacy and Safety of Three Dose Levels of SM-13496 Compared to Placebo and Haloperidol in Patients With Schizophrenia Who Are Experiencing an Acute Exacerbation of Symptoms
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 356
- Locations
- 33
- Primary Endpoint
- Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score
Study Overview
Brief Summary
The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a placebo and to haloperidol in patients with schizophrenia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Lurasidone 20 mg
Lurasidone 20 mg tablets
Intervention: Lurasidone 20 mg (Drug)
Lurasidone 40 mg
Lurasidone 40 mg tablets
Intervention: Lurasidone 40mg (Drug)
Lurasidone 80 mg
Lurasidone 2 40 mg tablets
Intervention: Lurasidone 80 mg (Drug)
Haloperidol 10mg
Haloperidol 10mg tablets
Intervention: Haloperidol 10mg (Drug)
Placebo
Matching Placebo to Lurasidone and Haloperidol
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score
Time Frame: Baseline and 6 weeks
The BPRS consists of 18 ordered categorical items (from "not present" to "extremely severe," on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately. The minimum score on the BPRS is 18 and the maximum is 126. The higher number indicates a worsening of schizophrenia.
Secondary Outcomes
- Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores(Baseline and 6 weeks)
- Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores(Baseline and 6 weeks)
- Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores(Baseline and 6 weeks)