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A Comparison Study of LY2140023 and Aripiprazole in Schizophrenia Patients | Clinical Trials | Clareo Health

TERMINATEDPHASE3

A Comparison Study of LY2140023 and Aripiprazole in Schizophrenia Patients

A Phase 3, Multicenter, Double-Blind Comparison of LY2140023 and Aripiprazole in Patients With DSM-IV-TR Schizophrenia Followed by Open-Label Treatment With LY2140023

NCT01328093•Denovo Biopharma LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine whether weight gain will be significantly less in LY2140023 than aripiprazole in patients with schizophrenia.

Detailed Description

The primary objective of this study was to test the hypothesis that mean weight gain, as assessed by change from baseline, would be statistically significantly less for flexibly dosed LY2140023 (20, 40, or 80 mg twice daily \[BID\]) than for flexibly dosed aripiprazole (10, 15, or 30 mg/day) in patients with schizophrenia after 24 weeks of double-blind treatment. This was a multicenter, randomized, double-blind, Phase 3 study to assess the safety and efficacy of LY2140023 (flexibly dosed between 20 and 80 mg BID) in patients with schizophrenia. An active control, aripiprazole (flexibly dosed between 10 and 30 mg/day), was included for comparison.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Clinical diagnosis of schizophrenia
•Female participants of childbearing age must test negative for pregnancy at screening and agree to use single, effective, medically acceptable method of birth control
•Participants must require initiation of or modification to current antipsychotic treatment as outpatients
•Participants 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
•Participants must be able to understand the nature of the study and have given their own informed consent

Exclusion Criteria

•Have been on treatment with aripiprazole in the past 2 months or are aripiprazole nonresponders
•Participants who are pregnant, nursing, or intend to become pregnant within 30 days of completing the study
•Hospitalized within 2 weeks of screening or have been hospitalized for an exacerbation of symptoms of schizophrenia with a discharge date in the past 2 months
•Participants who are actively suicidal
•Participants with uncorrected narrow-angle glaucoma, history of or current seizure disorder, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, uncontrolled thyroid condition or other serious or unstable illnesses
•Participants who have had electroconvulsive therapy (ECT) within 3 months prior to screening or will have ECT at any time during the study
•Participants with known medical history of Human Immunodeficiency Virus positive (HIV+) status
•Test positive for (1) Hepatitis C virus antibody or (2) Hepatitis B surface antigen (HBsAg) with or without positive Hepatitis B core total antibody
•Participants with a corrected QT interval (Bazett's; QTcB)\>450 milliseconds (msec) (male) or \>470 msec (female) at screening
•Participants who have a history of inadequate clinical response to antipsychotic treatment for schizophrenia
+6 more criteria

Locations (51)

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.

Cerritos, California, United States

Escondido, California, United States

Garden Grove, California, United States

Long Beach, California, United States

Oakland, California, United States

Sherman Oaks, California, United States

Coral Gables, Florida, United States

Maitland, Florida, United States

North Miami, Florida, United States

Sanford, Florida, United States

Key Dates

Start Date

April 1, 2011

Primary Completion Date

October 1, 2012

Completion Date

October 1, 2012

Last Updated

September 7, 2022

Enrollment

678

ACTUAL participants

Conditions

Schizophrenia

Interventions

LY2140023

DRUG

Aripiprazole

DRUG

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

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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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: September 7, 2022Data 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.

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A Comparison Study of LY2140023 and Aripiprazole in Schizophrenia Patients

Inclusion Criteria

Exclusion Criteria

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

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