A Long-Term, Open-Label, Study on Schizophrenia

Lilly

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Risperidone; Drug: Quetiapine; Drug: Aripiprazole; Drug: Olanzapine; Drug: LY2140023

Study type: Interventional

Funder types: Industry

Identifiers

NCT01129674

H8Y-MC-HBBO (Other Identifier)

11960

Details and patient eligibility

About

The primary purpose of the study is to help answer the following research questions:

How LY 2140023 can be tolerated by patients with Schizophrenia compared to standard of care treatment in 52 weeks time period.

Whether LY 2140023 can help patients with Schizophrenia.

Full description

The study includes 2 treatment periods. Study Period I will begin at patient randomization (enrollment into Study HBBO) and continue through the first 2 years of treatment. Study Period II will be only for patients randomized to treatment with LY2140023, and will begin after the patient has completed the second year of treatment. Patients who qualify for enrollment will be randomized in a 3:1 ratio (LY2140023 versus standard of care, respectively) into 2 treatment groups: flexible, twice-daily dose of LY2140023 or standard-of-care (olanzapine, risperidone, aripiprazole, or quetiapine). Those assigned to LY2140023 will have the option to continue on LY2140023 after 2 years if deemed appropriate by the investigator.

Enrollment: 1,210 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must have met all entry criteria for, and have completed, an acute, placebo-controlled clinical trial of LY2140023 (such as Study H8Y-MC-HBBM, or other acute, placebo-controlled LY2140023 studies if allowed by the protocols for those studies).
• Female patients of childbearing potential must agree to use a single, effective, medically acceptable method of birth control.
• Patients must be considered reliable and have a level of understanding sufficient to perform all tests and examinations required by the protocol.
• Patients must be able to understand the nature of the study and have given their own informed consent.

Exclusion criteria

• Are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an investigational product or nonapproved use of a drug or device (other than LY2140023), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
• Patients for whom treatment with olanzapine, risperidone, aripiprazole, quetiapine, or LY2140023, as specified in this protocol, is relatively or absolutely clinically contraindicated.
• Patients who have received treatment with clozapine at doses greater than 200 mg daily within 12 months prior to study enrollment, or who have received any clozapine at all during the month before study enrollment.
• Patients who require concomitant treatment with any other medication with primary central nervous system activity, other than those allowed in study protocol.
• Patients have risk of suicide.
• Patients diagnosed with substance dependence or substance abuse within the 6 months prior to study enrollment.
• Patients diagnosed with substance-induced psychosis within 7 days of study enrollment or at any time during the study.
• Female patients who are pregnant, nursing, lactating or who intend to become pregnant within 30 days of completing the study.
• Have known glaucoma.
• Have a history of some types of seizures.
• Have seizure liability inconsistent with the exclusion criteria of the completed acute feeder study.
• Patients who have had electroconvulsive therapy (ECT) within 3 months of study enrollment or who will have ECT at any time during the study.
• Patients with known Human Immunodeficiency Virus positive (HIV+) status.
• Patients have a serious disease, such as recent stroke, heart, liver, kidney, lung or blood diseases
• Patients with Parkinson's disease
• Are incapable of participating in the study or are unwilling to engage in a meaningful way as study participants.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,210 participants in 2 patient groups

Standard of Care

Active Comparator group

Treatment:

Drug: Quetiapine

Drug: Risperidone

Drug: Aripiprazole

Drug: Olanzapine

LY2140023

Experimental group

Description:

20mg, 40mg or 80mg After 104 weeks, patients have the option to continue on treatment until the end of the study

Treatment:

Drug: LY2140023