A Comparison Study of LY2140023 and Aripiprazole in Schizophrenia Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: LY2140023; Aripiprazole
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 678.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether weight gain will be significantly less in
      LY2140023 than aripiprazole in patients with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of schizophrenia

          -  Female participants of childbearing age must test negative for pregnancy at screening
             and agree to use single, effective, medically acceptable method of birth control

          -  Participants must require initiation of or modification to current antipsychotic
             treatment as outpatients

          -  Participants must be considered reliable, have a level of understanding sufficient to
             perform all tests and examinations required by the protocol, and be willing to perform
             all study procedures

          -  Participants must be able to understand the nature of the study and have given their
             own informed consent

        Exclusion Criteria:

          -  Have been on treatment with aripiprazole in the past 2 months or are aripiprazole
             nonresponders

          -  Participants who are pregnant, nursing, or intend to become pregnant within 30 days of
             completing the study

          -  Hospitalized within 2 weeks of screening or have been hospitalized for an exacerbation
             of symptoms of schizophrenia with a discharge date in the past 2 months

          -  Participants who are actively suicidal

          -  Participants with uncorrected narrow-angle glaucoma, history of or current seizure
             disorder, uncontrolled diabetes, certain diseases of the liver, renal insufficiency,
             uncontrolled thyroid condition or other serious or unstable illnesses

          -  Participants who have had electroconvulsive therapy (ECT) within 3 months prior to
             screening or will have ECT at any time during the study

          -  Participants with known medical history of Human Immunodeficiency Virus positive
             (HIV+) status

          -  Test positive for (1) Hepatitis C virus antibody or (2) Hepatitis B surface antigen
             (HBsAg) with or without positive Hepatitis B core total antibody

          -  Participants with a corrected QT interval (Bazett's; QTcB)>450 milliseconds (msec)
             (male) or >470 msec (female) at screening

          -  Participants who have a history of inadequate clinical response to antipsychotic
             treatment for schizophrenia

          -  Participants who have received treatment with any depot formulation of an
             antipsychotic medication within 1 dosing interval, minimum of 4 weeks, prior to
             screening

          -  Are currently enrolled in, or discontinued within the last 60 days from, a clinical
             trial involving an investigational product or unapproved use of a drug or device, or
             concurrently enrolled in any other type of medical research judged not to be
             scientifically or medically compatible with this study

          -  Have any other psychiatric diagnoses in addition to schizophrenia

          -  Have previously completed or withdrawn from this study, or any other study
             investigating LY2140023 or any predecessor molecules with glutamatergic activity

          -  Participants who have received an adequate treatment trial, in the opinion of the
             investigator, with clozapine at doses greater than 200 milligrams (mg) daily within 12
             months prior to screening, or who have received any clozapine at all during the month
             before screening

          -  Diagnosis of substance-induced psychosis within 7 days of screening (or at any time
             during the study)