NCT01328093

Brief Summary

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

Trial Health

68
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
678

participants targeted

Target at P75+ for phase_3 schizophrenia

Timeline
Completed

Started Apr 2011

Geographic Reach
10 countries

51 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
9.9 years until next milestone

Results Posted

Study results publicly available

September 7, 2022

Completed
Last Updated

September 7, 2022

Status Verified

August 1, 2022

Enrollment Period

1.5 years

First QC Date

March 31, 2011

Results QC Date

August 17, 2021

Last Update Submit

August 15, 2022

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline to 24 Weeks in Body Weight

    Mixed model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) mean and standard error. LS mean values were adjusted for baseline, treatment, gender, pooled investigator, visit, prior olanzapine use, treatment-by-visit interaction and baseline-by-visit interaction.

    Baseline, 24 weeks

Secondary Outcomes (15)

  • Percentage of Participants With Clinically Significant Weight Change

    Baseline up to 24 weeks

  • Change From Baseline up to 24 Weeks in Barnes Akathisia Scale (BAS)

    Baseline, 24 weeks

  • Change From Baseline up to 24 Weeks in Simpson-Angus Scale (SAS)

    Baseline, 24 weeks

  • Change From Baseline up to 24 Weeks in Abnormal Involuntary Movement Scale (AIMS)

    Baseline, 24 weeks

  • Change From Baseline up to 24 Weeks in Positive and Negative Syndrome Scale (PANSS) Total and Subscale Scores

    Baseline, 24 weeks

  • +10 more secondary outcomes

Study Arms (2)

LY2140023

EXPERIMENTAL

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.

Drug: LY2140023

Aripiprazole

ACTIVE COMPARATOR

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.

Drug: LY2140023Drug: Aripiprazole

Interventions

LY2140023DRUG

Administered orally

AripiprazoleLY2140023
AripiprazoleDRUG

Administered orally

Aripiprazole

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (51)

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Cerritos, California, 90703, United States

Location

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Escondido, California, 92025, United States

Location

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Garden Grove, California, 92845, United States

Location

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Long Beach, California, 90813, United States

Location

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Oakland, California, 94612, United States

Location

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Sherman Oaks, California, 91403, United States

Location

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Coral Gables, Florida, 33145, United States

Location

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Maitland, Florida, 32751, United States

Location

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North Miami, Florida, 33161, United States

Location

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Sanford, Florida, 32771, United States

Location

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Chicago, Illinois, 60640, United States

Location

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Indianapolis, Indiana, 46260, United States

Location

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Creve Coeur, Missouri, 63141, United States

Location

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Princeton, New Jersey, 08540, United States

Location

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Willingboro, New Jersey, 08046, United States

Location

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Brooklyn, New York, 11235, United States

Location

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Cedarhurst, New York, 11516, United States

Location

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Fresh Meadows, New York, 11366, United States

Location

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Rochester, New York, 14615, United States

Location

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Staten Island, New York, 10312, United States

Location

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Charlotte, North Carolina, 28211, United States

Location

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Beachwood, Ohio, 44122, United States

Location

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Canton, Ohio, 44718, United States

Location

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Oklahoma City, Oklahoma, 73103, United States

Location

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Eugene, Oregon, 97401, United States

Location

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Allentown, Pennsylvania, 18104, United States

Location

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Philadelphia, Pennsylvania, 19139, United States

Location

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Austin, Texas, 78754, United States

Location

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DeSoto, Texas, 75115, United States

Location

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Wharton, Texas, 77488, United States

Location

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Richmond, Virginia, 23230, United States

Location

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Bellevue, Washington, 98007, United States

Location

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Vienna, 1010, Austria

Location

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Liège, 4000, Belgium

Location

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Ottignies, 1340, Belgium

Location

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Douai, 59500, France

Location

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Limoges, 87025, France

Location

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Nîmes, 30029, France

Location

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Toulon, 83506, France

Location

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Dresden, 01307, Germany

Location

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Oranienburg, 16515, Germany

Location

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Bialystok, 15-879, Poland

Location

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Gdynia, 81-361, Poland

Location

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San Juan, 00926, Puerto Rico

Location

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Bucharest, 041914, Romania

Location

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Târgu Mureş, 540139, Romania

Location

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Madrid, 28031, Spain

Location

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Seville, 41700, Spain

Location

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Vic, 08500, Spain

Location

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Luleå, SE 972 35, Sweden

Location

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Malmo, 21153, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 24772351DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

LY 2140023Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Limitations and Caveats

The study was terminated early. 97% of participants had completed or discontinued from the DB Phase prior to termination. Outcome measure populations excluded data from a site that had significant GCP noncompliance issues (3 participants).

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2011

First Posted

April 4, 2011

Study Start

April 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

September 7, 2022

Results First Posted

September 7, 2022

Record last verified: 2022-08

Locations

PR(1)RO(2)DE(2)US(32)ES(3)SE(2)PL(2)BE(2)AU(1)FR(4)