Clinical trial NCT01086748 (phase 2, status: completed)
Conditions: schizophrenia
ICD codes: F20.0, F20.1, F20.2, F20.3, F20.5, F20.89, F20.9
Drugs: risperidone, placebo, ly2140023
SMILES: OCCOCCN1CCN(CC1)C1=NC2=CC=CC=C2SC2=CC=CC=C12, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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 patients who agree to use acceptable birth control

          -  At entry to the study must be considered moderately ill in the opinion of the
             investigator

          -  Willing to participate in a minimum of 3 weeks of inpatient hospitalization and this
             must be appropriate for the patient in the clinical judgment of the investigator.

          -  1 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

        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.

          -  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
             entering the study

          -  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, except for those who experienced a single
             simple febrile seizure between ages 6 months and 5 years

          -  Patients are excluded if their, biological father, mother, brother, sister, or child
             has a history of idiopathic epilepsy.

          -  Within 1 year of study enrollment, patients 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

          -  Patients are excluded if they have a lifetime history of any of the following:

               -  head trauma, stroke, or 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