| 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.
- 2 year history of Schizophrenia prior to entering the study
- A lifetime history of at least one hospitalization for the treatment of
schizophrenia, not including required study hospitalization .
- 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.
- 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 signed informed consent in the 6 months prior to entry in the study
- Previously completed or withdrawn from this study, or any other study investigating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 who have received continuous treatment with risperidone greater than 72
hours in duration within 6 weeks prior to 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.
- Female patients who are pregnant, nursing, or who intend to become pregnant within 30
days of completing the study.
- Have known, uncorrected, narrow-angle glaucoma.
- Have a history of one or more seizures, except for those who experienced a single
simple seizure ,caused by a high fever, 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.
- Untreated hyper- or hypothyroidism.
- Leukopenia
- Medical history of Human Immunodeficiency Virus positive (HIV+) status.
- Alanine aminotransferase / Serum glutamic-pyruvic transaminase or Aspartate
transaminase / serum glutamic oxaloacetic transaminase values >2 times upper limit of
normal of the performing laboratory, or total bilirubin values >1.5 times the upper
limit of normal of the performing laboratory
- Acute, serious, or unstable medical conditions not otherwise listed
- Higher than normal blood prolactin levels
- Certain electrocardiogram results |