A Study in Schizophrenic Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: LY2140023; Placebo
Intervention description: Administered orally, twice daily for up to 7 weeks of treatment; Administered orally, twice daily for up to 7 weeks of treatment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 82.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study is designed to compare 3 doses of LY2140023 for the treatment of schizophrenia as
      assessed at endpoint (up to 7 weeks) using the Clinical Utility Index (CUI), a measure of
      efficacy, safety, and tolerability.
    

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; 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)

          -  Non pregnant female participants who agree to use acceptable birth control

          -  At entry to the study must be considered moderately ill in the opinion of the
             investigator

          -  1 year history of Schizophrenia prior to entering the study

          -  At study entry participants 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 based on the investigator's
             clinical judgment. Participants who have never taken antipsychotic treatment may enter
             the study even without a history of hospitalization

          -  At study entry participants 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. Participants 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 participants must have experienced an exacerbation of illness within
             the 4 weeks prior to entering the study, leading to an intensification of psychiatric
             care in the opinion of the investigator. If exacerbation occurs in participants who
             are presently hospitalized, the participants must not have been hospitalized longer
             than 60 days at entry of the study

        Exclusion Criteria:

          -  Participated in any clinical trial with any pharmacological treatment intervention for
             which they received a study-related medication in the 6 months prior to visit 1

          -  Previously completed or withdrawn from this study, or any other study investigating
             LY2140023 or any predecessor molecules with glutamatergic activity

          -  Have any known history of receiving treatment with clozapine at any dose, as
             determined at baseline

          -  Have received treatment with a depot formulation of an antipsychotic medication within
             the 6 months prior entering the study

          -  Participants who are currently suicidal

          -  Females who are pregnant, nursing, or who intend to become pregnant within 30 days of
             completing the study

          -  Participants with uncorrected narrow-angle glaucoma, uncontrolled diabetes, certain
             diseases of the liver, renal insufficiency, untreated thyroid condition or other
             serious or unstable illnesses

          -  Have a history of one or more seizures, except for those who experienced a single
             simple febrile seizure between ages 6 months and 5 years

          -  Participants are excluded if their biological father, mother, brother, sister, or
             child has a history of idiopathic epilepsy

          -  Within 1 year of study enrollment, participants have a history of central nervous
             system infection, uncontrolled migraine, transient ischemic attack (TIA), or head
             trauma with loss of consciousness or a post-concussive

          -  Participants are excluded if they have a lifetime history of any of the following:

               -  head trauma, stroke, or central nervous system (CNS) infection with persistent
                  neurological deficit (focal or diffuse);

               -  brain surgery;

               -  an electroencephalogram with paroxysmal (epileptiform) activity, or

               -  brain structural lesion, including developmental abnormalities, as determined by
                  examination or previous neuroimaging studies that are consistent with a
                  diagnosable neurological disease or syndrome

          -  Electroconvulsive therapy (ECT) within 3 months of entering the study or who will have
             ECT at any time during the study

          -  Leukopenia

          -  Medical history of Human Immunodeficiency Virus positive (HIV+) status

          -  Higher than normal blood prolactin levels

          -  Certain electrocardiogram results