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A Long-Term, Open-Label, Study on Schizophrenia | Clinical Trials | Clareo Health

TERMINATEDPHASE2/PHASE3

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

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

NCT01129674•Eli Lilly and Company

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.

Detailed 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.

Eligibility

Age

18 - 65 years

Sex

ALL

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.
+5 more criteria

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

Key Dates

Start Date

June 1, 2010

Primary Completion Date

October 1, 2012

Completion Date

October 1, 2012

Last Updated

January 21, 2013

Enrollment

1,210

ESTIMATED participants

Conditions

Schizophrenia

Interventions

LY2140023

DRUG

Olanzapine

DRUG

Aripiprazole

DRUG

Risperidone

DRUG

Quetiapine

DRUG

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

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