Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

Time to Discontinuation Due to Adverse Event (AE)
Baseline through 24 weeks

Secondary Outcomes (25)

Number of Participants With Shift From Baseline to Maximum Post-Baseline Grading in Electroencephalograms (EEGs)
Baseline through 52 weeks
Number of Participants With Potentially Clinically Significant Changes in QT Intervals Electrocardiograms (ECGs)
Baseline through 24 weeks
Number of Participants With Treatment-Emergent Change in Neurological Examination
Baseline through 52 weeks
Change From Baseline in Blood Pressure (BP) at 52 Weeks Endpoint
Baseline, 52 weeks
Change From Baseline in Weight at 52 Weeks Endpoint
Baseline, 52 weeks
+20 more secondary outcomes

Study Arms (4)

LY2140023

EXPERIMENTAL

LY2140023 (80 mg/day), given orally twice daily as two 40-mg tablets for 24 weeks

Drug: LY2140023

aripiprazole

ACTIVE COMPARATOR

aripiprazole (20 mg/day), given orally once daily for 24 weeks

Drug: aripiprazole

olanzapine

ACTIVE COMPARATOR

olanzapine (15 mg/day), given orally once daily for 24 weeks

Drug: olanzapine

risperidone

ACTIVE COMPARATOR

risperidone (4 mg/day), given orally, once or BID for 24 weeks

Drug: risperidone

Interventions

LY2140023DRUG

80 milligram (mg), oral tablets, twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40 mg or a maximum of 160 mg.

Also known as: pomaglumetad methionil

LY2140023

aripiprazoleDRUG

10 mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20 mg, 2-10 mg oral tablets, once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 30 mg (3-10 mg oral tablets).

Also known as: Abilify

aripiprazole

olanzapineDRUG

10 mg dose (2-5 mg oral tablets) once every evening, for 3 days. Followed by an increase to 15 mg (3-5 mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10 mg or a maximum of 20 mg (4-5 mg oral tablets).

Also known as: Zyprexa

olanzapine

risperidoneDRUG

2 mg dose, 2-1 mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4 mg (4-1 mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2 mg/day or a maximum of 6 mg/day (6-1 mg tablets).

Also known as: Risperdal

risperidone

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Clinical diagnosis of schizophrenia
Patients, in the investigator's opinion, must require a switch to another antipsychotic medication as clinically indicated or initiation of an antipsychotic agent
Patients must be willing and able to be hospitalized, or to remain hospitalized (if already hospitalized), for up to 17 days
The investigator expects, at the time of enrollment, that the patient will be able to be discharged from the hospital after the first 2 weeks of active treatment
Disease symptoms must meet a certain range as assessed by the clinician
Patients must have evidence of functional impairment (i.e. social or vocational deficiency)
Patients must be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures
Patients must be able to understand the nature of the study and have given their informed consent

You may not qualify if:

Patients who are actively suicidal
Patients who are pregnant or nursing
Patients who have had electroconvulsive therapy (ECT) within 3 months of screening or who will have ECT at any time during the study
Patients with uncorrected narrow-angle glaucoma, seizures, uncontrolled diabetes, certain diseases of the liver, uncontrolled thyroid condition or other serious or unstable illnesses
Patients with Parkinson's disease, psychosis related to dementia or related disorders
Patients with known Human Immunodeficiency Virus positive (HIV+) status

Contact the study team to confirm eligibility.