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

Phase 3TerminatedNCT01129674

Denovo Biopharma LLC560 enrolled

Overview

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.

The study includes 2 treatment periods. Study Period I will begin at participant randomization (enrollment into Study HBBO) and continue through the first 2 years of treatment. Study Period II will be only for participants randomized to treatment with LY2140023, and will begin after the participant has completed the second year of treatment. Participants 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

560

Conditions

Schizophrenia

Interventions

LY2140023DRUG

Administered orally, twice daily for 104 weeks

OlanzapineDRUG

Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks

AripiprazoleDRUG

Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 participants of childbearing potential must agree to use a single, effective, medically acceptable method of birth control. * Participants must be considered reliable and have a level of understanding sufficient to perform all tests and examinations required by the protocol. * Participants 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. * Participants for whom treatment with olanzapine, risperidone, aripiprazole, quetiapine, or LY2140023, as specified in this protocol, is relatively or absolutely clinically contraindicated. * Participants 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. * Participants who require concomitant treatment with any other medication with primary central nervous system activity, other than those allowed in study protocol. * Participants have risk of suicide. * Participants diagnosed with substance dependence or substance abuse within the 6 months prior to study enrollment. * Participants diagnosed with substance-induced psychosis within 7 days of study enrollment or at any time during the study. * Female participants 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. * Participants who have had electroconvulsive therapy (ECT) within 3 months of study enrollment or who will have ECT at any time during the study. * Participants with known Human Immunodeficiency Virus positive (HIV+) status. * Participants have a serious disease, such as recent stroke, heart, liver, kidney, lung or blood diseases * Participants with Parkinson's disease * Are incapable of participating in the study or are unwilling to engage in a meaningful way as study participants.

Locations (81)

Outcomes

Primary Outcomes

Time to discontinuation due to adverse events

Time frame: Baseline through 52 weeks