Indication: Schizophrenia (Acute)

# of Subjects: 13 subjects screened; 5 subjects screen failed; 6 completed; 2terminated early

Inpatient Period: 28-35 Days

Objectives

Primary

• Efficacy using the PANSS to measure change in symptoms
• Safety and tolerability of two fixed dose regimens of XXXXX
• Incidence rate of dystonia
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Secondary

Safety: Adverse events, weight and abdominal girth, vital signs, physical examination, neurological examination,electrocardiogram (ECG) and clinical laboratory findings

Change from baseline to Week 4 on:

PANSS

CGI-Improvement

CGI-Severity

Global Assessment of Functioning (GAF)

Brief Psychiatric Rating Scale (BPRS)

Treatment Satisfaction Questionnaire for Medication (TSQM)

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Ratings

Brief Psychiatric Rating Scale (BPRS)

Positive and Negative Syndrome Scale (PANSS)

Clinical Global Impression-Severity (CGI-S)

Clinical Global Impression-Improvement (CGI-I)

Abbreviated Extrapyramidal Symptom Rating Scale (ESRS-A)

Global Assessment of Functioning (GAF)

Treatment Satisfaction Questionnaire for Medication (TSMQ)

Columbia-Suicide Severity Rating Scale (C-SSRS)

Suicidal Behavior Questionnaire Revised (SBQ-R)

Lab Assessments — 43 per subject

Screening — Days 1-28, Follow-up

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ECGs (Triplicate)

Screening, Day 1, Day 14, Day 28, Follow-up

Vitals

Screening, Days 1-29, Follow-up

Clintara

Appropriate subject selection confirmed by Clintara through C-Visa (Clinical Validation Inventory for Subject Admission)

Diagnostic verification, symptom severity confirmation, subject validity and reliability

All 13 subjects screened by St. Louis Clinical Trials passed independent review by Clintara without disagreement (i.e., no tier 2 review necessary)