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TERMINATED

NCT01129674

PHASE2/PHASE3

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

Sponsor: Denovo Biopharma LLC

View on ClinicalTrials.gov

Summary

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.

Official title: A Long-Term, Open-Label, Multicenter Study of LY2140023 Compared to Atypical Antipsychotic Standard of Care in Patients With DSM-IV-TR Schizophrenia

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

560

Start Date

2010-06

Completion Date

2012-10

Last Updated

2026-09-14

Healthy Volunteers

Conditions

Schizophrenia

Interventions

DRUG

LY2140023

Administered orally, twice daily for 104 weeks

DRUG

Olanzapine

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

DRUG

Aripiprazole

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

DRUG

Risperidone

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

DRUG

Quetiapine

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

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)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Little Rock, Arkansas, United States

Escondido, California, United States

Garden Grove, California, United States

Long Beach, California, United States

National City, California, United States

Oakland, California, United States

Oceanside, California, United States

Paramount, California, United States

Pasadena, California, United States

San Diego, California, United States

Sherman Oaks, California, United States

Torrance, California, United States

Washington D.C., District of Columbia, United States

Fort Lauderdale, Florida, United States

Hollywood, Florida, United States

Kissimmee, Florida, United States

Maitland, Florida, United States

University Park, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Hoffman Estates, Illinois, United States

Indianapolis, Indiana, United States

Wichita, Kansas, United States

Lake Charles, Louisiana, United States

Shreveport, Louisiana, United States

Flowood, Mississippi, United States

Creve Coeur, Missouri, United States

Marlton, New Jersey, United States

Buffalo, New York, United States

Cedarhurst, New York, United States

Holliswood, New York, United States

New York, New York, United States

Rochester, New York, United States

Cincinnati, Ohio, United States

Dayton, Ohio, United States

Philadelphia, Pennsylvania, United States

Austin, Texas, United States

Dallas, Texas, United States

DeSoto, Texas, United States

Houston, Texas, United States

Richmond, Virginia, United States

Roanoke, Virginia, United States

Zagreb, Croatia

Aichi, Japan

Kanagawa, Japan

Kumamoto, Japan

Kyoto, Japan

Nagano, Japan

Nagasaki, Japan

Nara, Japan

Osaka, Japan

Saga, Japan

Tokyo, Japan

Toyama, Japan

Guadalajara, Mexico

Monterrey, Mexico

Ponce, Puerto Rico

San Juan, Puerto Rico

Khot'kovo, Russia

Lipetsk, Russia

Moscow, Russia

Nizhny Novgorod, Russia

Saint Petersburg, Russia

Samara, Russia

Saratov, Russia

Tomsk, Russia

Voronezh, Russia

Yaroslavl, Russia

Goyang-si, South Korea

Incheon, South Korea

Naju, South Korea

Seoul, South Korea

Suwon, South Korea

Yongin, South Korea

Changhua, Taiwan

Neihu District, Taiwan

Taipei, Taiwan

Donetsk, Ukraine

Kherson, Ukraine

Kiev, Ukraine

Vinnytsia, Ukraine

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (81)