A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Lurasidone 20 mg
* Drug: Lurasidone 40mg
* Drug: Lurasidone 80 mg
* Drug: Haloperidol 10mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: The patient has a primary diagnosis of schizophrenia The patient has been hospitalized with acute or relapsing schizophrenia within 3 weeks of screening The patient has had a duration of illness of at least one year. The patient has a BPRS score of at least 42 at baseline and a score of at least 4 in two or more items of the positive symptom subcluster on the PANSS The patient is able to remain off antipsychotic medication for a 4 day washout period Exclusion criteria: The patient has had psychiatric hospitalizations other than current hospitalizations within 1 month prior to screening. The patient is considered treatment resistant-Substance abuse-Prolactin level of > 200 ng/mL at baseline Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lurasidone 20 mg<br>Lurasidone 20 mg tablets | Drug: Lurasidone 20 mg<br>* Lurasidone 20mg/day tablets<br>|
| Experimental: Lurasidone 40 mg<br>Lurasidone 40 mg tablets | Drug: Lurasidone 40mg<br>* Lurasidone 40mg/day tablets<br>|
| Experimental: Lurasidone 80 mg<br>Lurasidone 2 40 mg tablets | Drug: Lurasidone 80 mg<br>* Lurasidone 80mg/day - 2 40mg tablets<br>|
| Active Comparator: Haloperidol 10mg<br>Haloperidol 10mg tablets | Drug: Haloperidol 10mg<br>* Haloperidol 10mg/day tablets<br>|
| Placebo Comparator: Placebo<br>Matching Placebo to Lurasidone and Haloperidol | Drug: Placebo<br>* Matching Placebo to Lurasdione and Haloperidol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score | 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. | Baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores | The PANSS Positive and Negative Syndrome Scale)is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia. | Baseline and 6 weeks | 
| Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores | The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). | Baseline and 6 weeks | 
| Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores | The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. | Baseline and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Latuda, Lurasidone