Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

Clinical Utility Index (CUI)
CUI measures the efficacy (response), tolerability (time on treatment) and safety \[incidence of adverse events (AEs)\] by quantifying these 3 attributes and provides a single metric for overall treatment outcome. Each component is given a score ranging from 0 to 5. The CUI Total Score is the sum of the 3 items and ranges from 0 to 15. The greater the CUI Total Score, the more effective the treatment. If a participant experiences a drug-related seizure/death, the safety component is given a score of 0 resulting in an overall CUI Total Score of 0. Analysis of variance (ANOVA) was used to calculate Least Squares (LS) mean and standard error. LS mean values were controlled for treatment, gender and pooled investigators.
Baseline through Week 6

Secondary Outcomes (5)

Change From Baseline to Week 6 Endpoint in the Positive and Negative Syndrome Scale (PANSS) Total Score, Positive Score, Negative Score, and Psychopathology Subscale
Baseline, Week 6
Change From Baseline to Week 6 Endpoint in the Clinical Global Impression-Severity Scale (CGI-S)
Baseline, Week 6
Change From Baseline to Week 6 Endpoint in the 16-item Negative Symptoms Assessment (NSA-16)
Baseline, Week 6
The Number of Participants With Treatment-Emergent Suicidal Ideation and Behavior Based on the Columbia Suicide Severity Rating Scale (C-SSRS)
Baseline up to Week 6
Percentage of Participants Who Discontinued (Rate of Discontinuation)
Baseline through Week 6

Study Arms (4)

10 milligrams (mg) LY2140023

EXPERIMENTAL

Drug: LY2140023

80 mg LY2140023

EXPERIMENTAL

Drug: LY2140023

160 mg LY2140023

EXPERIMENTAL

Drug: LY2140023

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

LY2140023DRUG

Administered orally, twice daily for up to 7 weeks of treatment

10 milligrams (mg) LY2140023160 mg LY214002380 mg LY2140023

PlaceboDRUG

Administered orally, twice daily for up to 7 weeks of treatment

Placebo

Eligibility Criteria

Age20 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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
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

You may not qualify if:

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
+5 more criteria

Contact the study team to confirm eligibility.