A Study of LY2140023 in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: LY2140023; Placebo
Intervention description: Administered orally; Administered orally
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 567.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether at least 1 dose level of LY2140023 given to
      acutely ill patients with schizophrenia will demonstrate significantly greater efficacy as
      compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of schizophrenia as defined in the Diagnostic and Statistical Manual of
             Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR); and confirmed by the
             Structured Clinical Interview for DSM-IV-TR (SCID)

          -  Non pregnant female patients who agree to use acceptable birth control

          -  Participants must be considered moderately ill in the opinion of the investigator

          -  Patients in whom a modification of antipsychotic medication or initiation of
             antipsychotic medication is acutely indicated in the opinion of the investigator

          -  Willing to participate in a minimum of 2 weeks of inpatient hospitalization

          -  One year history of Schizophrenia prior to entering the study

          -  At study entry patients with a history of antipsychotic treatment must have a lifetime
             history of at least one hospitalization for the treatment of schizophrenia, not
             including the hospitalization required for study. Patients who have never taken
             antipsychotic treatment may enter the study even without a history of hospitalization.

          -  At study entry patients with a history of antipsychotic treatment must have a history
             of at least one episode of illness exacerbation requiring an intensification of
             treatment intervention or care in the last 2 years, not including the present episode
             of illness. Patients who have never taken antipsychotic treatment may enter the study
             without a past history of illness exacerbation and intensification of treatment in the
             last 2 years.

          -  At study entry patients must have experienced an exacerbation of illness within the 2
             weeks prior to entering the study, leading to an intensification of psychiatric care
             in the opinion of the investigator. If exacerbation occurs in patients who are
             presently hospitalized, the patient must not have been hospitalized longer than 60
             days at entry of the study.

          -  Patients must be considered reliable and have a level of understanding sufficient to
             perform all tests and examinations required by the protocol, and be willing to perform
             all study procedures

        Exclusion Criteria:

          -  Patients who have a history of inadequate clinical response to antipsychotic treatment
             for schizophrenia

          -  Diagnosis of substance dependence or substance abuse within 6 month of study entry

          -  Diagnosis of substance-induced psychosis within 7 days of study entry

          -  Currently enrolled in, or discontinued within 6 months from a clinical trial involving
             an investigational product or unapproved use of a drug or device

          -  Participated in any clinical trial with any pharmacological treatment intervention for
             which they received a study-related medication in the 6 months prior to study entry

          -  Previously completed or withdrawn from this study, or any other study investigating
             LY2140023 or any predecessor molecules with glutamatergic activity

          -  Treatment with clozapine at doses greater than 200 mg daily within 12 months prior to
             entering the study, or who have received any clozapine at all during the month before
             study entry

          -  Patients currently receiving treatment (within 1 dosing interval, minimum of 4 weeks,
             prior entering the study) with a depot formulation of an antipsychotic medication

          -  Patients who are currently suicidal

          -  Females who are pregnant, nursing, or who intend to become pregnant within 30 days of
             completing the study

          -  Patients with uncorrected narrow-angle glaucoma, uncontrolled diabetes, certain
             diseases of the liver, renal insufficiency, uncontrolled thyroid condition or other
             serious or unstable illnesses

          -  Have a history of one or more seizures

          -  Electroconvulsive therapy (ECT) within 3 months of entering the study or who will have
             ECT at any time during the study

          -  History of low white blood cell count

          -  Medical history of Human Immunodeficiency Virus positive (HIV+) status.

          -  Higher than normal blood prolactin levels

          -  Abnormal electrocardiogram results