A Physical Dependence Study in 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: schizophrenia, LY2140023, pomaglumetad methionil

Summary:

      The purpose of this study is to determine whether or not people with schizophrenia who take
      LY2140023 become physically dependent on it, and experience a series of symptoms such as
      craving to have the drug when they stop using it.

      This trial consists of two phases: An open-label phase consisting of up to 4 weeks and a
      double-blind phase consisting of up to 3 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of schizophrenia

          -  Female participants of childbearing potential must test negative for pregnancy at
             study entry and agree to use a single, effective, medically acceptable method of birth
             control

          -  Participants must require a modification of antipsychotic medication or the initiation
             of antipsychotic medication, as indicated by their present clinical psychiatric status
             and/or treatment tolerability as outpatients

          -  Participants must be considered reliable and have a level of understanding sufficient
             to perform all tests and examinations required, 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 a Clinical Global Impression-Severity Scale (CGI-S) score >4 at study entry

          -  Have any other psychiatric diagnoses in addition to schizophrenia

          -  Participants who have a history of inadequate clinical response to antipsychotic
             treatment for schizophrenia

          -  Participants who have received an adequate treatment trial, in the opinion of the
             investigator, with clozapine at doses >200 mg daily within 12 months prior to study
             entry, or who have received any clozapine at all during the month before study entry

          -  Participants who are actively suicidal

          -  Female participants who are pregnant, nursing, or who intend to become pregnant within
             30 days of completing the study

          -  Have known, uncorrected, narrow-angle glaucoma

          -  Participants who have had electroconvulsive therapy (ECT) within 3 months of study
             entry or who will have ECT at any time during the study

          -  Participants with known medical history of human immunodeficiency virus positive
             (HIV+) status

          -  Participants who test positive for Hepatitis C virus antibody or Hepatitis B surface
             antigen (HBsAg) with or without positive Hepatitis B core total antibody

          -  Participants with current or a history of seizure disorder, uncontrolled diabetes,
             certain diseases of the liver, renal insufficiency, uncontrolled thyroid condition or
             other serious or unstable illnesses

          -  Participants with a corrected QT interval (Bazett's; QTcB) >450 milliseconds (msec)
             (male) or >470 msec (female) at study entry (based on the central vendor's
             electrocardiogram [ECG] overread)

          -  Have previously completed or withdrawn from this study, or any other study
             investigating LY2140023 or any predecessor molecules with glutamatergic activity

          -  Are currently enrolled in, or discontinued within the last 60 days from, a clinical
             trial involving an investigational product for 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