A Phase 3, Multicenter, Double-Blind Comparison of LY2140023 and Aripiprazole in Patients with DSM-IV-TR Schizophrenia Followed by Open-Label Treatment with LY2140023 - HBDE

INTERVENTION: Product Name: LY2140023 Product Code: LY2140023 Pharmaceutical Form: Tablet CAS Number: 635318‐55‐7 Current Sponsor code: LY2140023 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: LY2140023 Product Code: LY2140023 Pharmaceutical Form: Tablet CAS Number: 635318‐55‐7 Current Sponsor code: LY2140023 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: LY2140023 Product Code: LY2140023 Pharmaceutical Form: Tablet CAS Number: 635318‐55‐7 Current Sponsor code: LY2140023 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Abilify Product Name: Abilify Pharmaceutical Form: Capsule* INN or Proposed INN: ARIPIPRAZOLE CAS Number: 129722‐12‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Trade Name: Abilify Product Name: Abilify Pharmaceutical Form: Capsule* INN or Proposed INN: ARIPIPRAZOLE CAS Number: 129722‐12‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use CONDITION: Schizophrenia ; MedDRA version: 12.1 Level: LLT Classification code 10039626 Term: Schizophrenia PRIMARY OUTCOME: Main Objective: The primary objective of this study is to test the hypothesis that mean weight gain, as assessed by change from baseline, will be statistically significantly less for flexibly dosed LY2140023 (20, 40, or 80 mg BID) than for flexibly dosed aripiprazole (10, 15, or 30 mg/day) in patients with schizophrenia after 24 weeks of double‐blind treatment. Primary end point(s): Change from baseline in body weight during the double‐blind treatment phase Secondary Objective: The main secondary objectives are as follows, please refer to the Protocol Section 6.2 for further details.; •To test the hypothesis that the proportion of patients with potentially clinically significant weight gain, will be statistically significantly less for LY2140023 than for aripiprazole after 24 weeks of double‐blind treatment.; •To evaluate the safety and tolerability of LY2140023 compared with aripiprazole ; •To evaluate the efficacy of LY2140023 compared with aripiprazole ; •To evaluate the efficacy of LY2140023 compared with aripiprazole within a prospectively defined genetic subgroup; •To assess whether LY2140023 demonstrates improvement compared with aripiprazole on health outcomes, including quality of life and functioning ; •To further evaluate efficacy, safety, and tolerability of LY2140023 through assessment of all efficacy and safety measures at the end of the 28‐week open‐label phase.; INCLUSION CRITERIA: [1] Patients are male or female, 18 to 65 years of age (inclusive) at study entry, with a diagnosis of schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM‐IV‐TR; APA 2000) (Disorganized, 295.10; Catatonic, 295.20; Paranoid 295.30; or Undifferentiated, 295.90) and confirmed by the Structured Clinical Interview for DSM‐IV‐TR (SCID). [2] Female patients of childbearing potential must test negative for pregnancy at Visit 1 and agree to use a single, effective, medically acceptable method of birth control, specifically: an oral contraceptive combined pill; an implantable contraceptive; an injectable contraceptive; a contraceptive patch (for women <198 pounds or 90 Kg); or an intrauterine device/system. The double‐barrier method, as defined by two physical barriers such as a condom, diaphragm, or cervical occlusive cap, coupled with an additional barrier such as spermicidal foam, gel, film, cr