A Comparison Study of LY2140023 and Aripiprazole in Schizophrenia Patients

NCT ID: NCT01328093

Last Updated: 2022-09-07

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

678 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-10-31

Brief Summary

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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

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LY2140023

Double Blind Phase: 40 milligrams (mg) administered orally, given twice daily for 24 weeks. Dose may be adjusted to a minimum of 20 mg or a maximum of 80 mg. Open Label Phase: 40 mg administered orally, given twice daily for an additional 28 weeks.

Group Type EXPERIMENTAL

LY2140023

Intervention Type DRUG

Administered orally

Aripiprazole

Double Blind Phase: 15 mg administered orally, given once daily for 24 weeks. Dose can be adjusted to a minimum of 10 mg or a maximum of 30 mg. Open Label Phase: LY2140023, 40 mg administered orally, given twice daily for an additional 28 weeks.

Group Type ACTIVE_COMPARATOR

LY2140023

Intervention Type DRUG

Administered orally

Aripiprazole

Intervention Type DRUG

Administered orally

Interventions

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LY2140023

Administered orally

Intervention Type DRUG

Aripiprazole

Administered orally

Intervention Type DRUG

Eligibility Criteria

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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
* Participants who have received treatment with any depot formulation of an antipsychotic medication within 1 dosing interval, minimum of 4 weeks, prior to screening
* Are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an investigational product or unapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
* Have any other psychiatric diagnoses in addition to schizophrenia
* Have previously completed or withdrawn from this study, or any other study investigating LY2140023 or any predecessor molecules with glutamatergic activity
* Participants who have received an adequate treatment trial, in the opinion of the investigator, with clozapine at doses greater than 200 milligrams (mg) daily within 12 months prior to screening, or who have received any clozapine at all during the month before screening
* Diagnosis of substance-induced psychosis within 7 days of screening (or at any time during the study)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Denovo Biopharma LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Cerritos, California, United States

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Escondido, California, United States

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Garden Grove, California, United States

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Long Beach, California, United States

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Oakland, California, United States

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Sherman Oaks, California, United States

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Coral Gables, Florida, United States

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Maitland, Florida, United States

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North Miami, Florida, United States

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Sanford, Florida, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Creve Coeur, Missouri, United States

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Princeton, New Jersey, United States

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Willingboro, New Jersey, United States

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Brooklyn, New York, United States

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Cedarhurst, New York, United States

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Fresh Meadows, New York, United States

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Rochester, New York, United States

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Staten Island, New York, United States

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Charlotte, North Carolina, United States

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Beachwood, Ohio, United States

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Canton, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Allentown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Austin, Texas, United States

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DeSoto, Texas, United States

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Wharton, Texas, United States

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Richmond, Virginia, United States

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Bellevue, Washington, United States

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Vienna, , Austria

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Liège, , Belgium

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Ottignies, , Belgium

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Douai, , France

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Limoges, , France

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Nîmes, , France

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Toulon, , France

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Dresden, , Germany

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Oranienburg, , Germany

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Bialystok, , Poland

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Gdynia, , Poland

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San Juan, , Puerto Rico

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Bucharest, , Romania

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Târgu Mureş, , Romania

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Madrid, , Spain

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Seville, , Spain

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Vic, , Spain

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Luleå, , Sweden

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Malmo, , Sweden

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Countries

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United States Austria Belgium France Germany Poland Puerto Rico Romania Spain Sweden

References

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Adams DH, Zhang L, Millen BA, Kinon BJ, Gomez JC. Pomaglumetad Methionil (LY2140023 Monohydrate) and Aripiprazole in Patients with Schizophrenia: A Phase 3, Multicenter, Double-Blind Comparison. Schizophr Res Treatment. 2014;2014:758212. doi: 10.1155/2014/758212. Epub 2014 Mar 19.

Reference Type DERIVED
PMID: 24772351 (View on PubMed)

Other Identifiers

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H8Y-MC-HBDE

Identifier Type: OTHER

Identifier Source: secondary_id

14211

Identifier Type: -

Identifier Source: org_study_id

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