A Comparison Study of LY2140023 and Aripiprazole in Schizophrenia Patients

This study has been terminated.
(The decision to stop the trial was based on efficacy results in the overall schizophrenia participant population.)
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01328093
First received: March 31, 2011
Last updated: January 11, 2013
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: LY2140023
Drug: Aripiprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from baseline to 24 weeks in body weight [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of participants with clinically significant weight change [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline up to 24 weeks in Barnes Akathisia Scale (BAS) [ Time Frame: Baseline, up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline up to 24 weeks in Simpson-Angus Scale (SAS) [ Time Frame: Baseline, up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline up to 24 weeks in Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline, up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline up to 24 weeks in Positive and Negative Syndrome Scale (PANSS) total and subscale scores [ Time Frame: Baseline, up to 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline up to 24 weeks in EuroQol-5 Dimensions Questionnaire (EQ-5D) [ Time Frame: Baseline, up to 24 weeks ] [ Designated as safety issue: No ]
  • Schizophrenia Resource Utilization Module (S-RUM) [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline up to 24 weeks in Subjective Well-Being Under Neuroleptic Treatment Scale- Short Form (SWN-S) total score and domain scores [ Time Frame: Baseline, up to 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline up to 24 weeks in Personal and Social Performance (PSP) Score [ Time Frame: Baseline, up to 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline up to 24 weeks in Clinical Global Impression-Severity Scale (CGI-S) [ Time Frame: Baseline, up to 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline up to 24 weeks in 16-Item Negative Symptom Assessment (NSA-16) [ Time Frame: Baseline, up to 24 weeks ] [ Designated as safety issue: No ]
  • Number of Participants with 30% decrease in PANSS total score [ Time Frame: Baseline up to 24 weeks ] [ Designated as safety issue: No ]
  • Number of Participants with suicidal behaviors and ideations measured by Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: Yes ]
  • Time to discontinuation [ Time Frame: Baseline up to 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 670
Study Start Date: April 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2140023
Double Blind Phase: 40 mg administered orally, given twice daily for 24 weeks. Dose may be adjusted to a minimum of 20 mg and a maximum of 80 mg. Open Label Phase: 40 mg administered orally, given twice daily for an additional 28 weeks.
Drug: LY2140023
Administered orally
Active Comparator: 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.
Drug: LY2140023
Administered orally
Drug: Aripiprazole
Administered orally

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of schizophrenia
  • Female patients of childbearing age must test negative for pregnancy at screening and agree to use single, effective, medically acceptable method of birth control
  • Patients must require initiation of or modification to current antipsychotic treatment as outpatients
  • Patients 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
  • Patients 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
  • Patients 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
  • Patients who are actively suicidal
  • Patients 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
  • Patients who have had electroconvulsive therapy (ECT) within 3 months prior to screening or will have ECT at any time during the study
  • Patients 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
  • Patients with a corrected QT interval (Bazett's; QTcB)>450 msec (male) or >470 msec (female) at screening
  • Patients who have a history of inadequate clinical response to antipsychotic treatment for schizophrenia
  • Patients 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
  • Patients who have received an adequate treatment trial, in the opinion of the investigator, with clozapine at doses greater than 200 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328093

  Hide Study Locations
Locations
United States, California
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Cerritos, California, United States, 90703
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Escondido, California, United States, 92025
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Garden Grove, California, United States, 92845
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Long Beach, California, United States, 90813
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Oakland, California, United States, 94612
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Sherman Oaks, California, United States, 91403
United States, Florida
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Coral Gables, Florida, United States, 33145
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Maitland, Florida, United States, 32751
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North Miami, Florida, United States, 33161
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Sanford, Florida, United States, 32771
United States, Illinois
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Chicago, Illinois, United States, 60640
United States, Indiana
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Indianapolis, Indiana, United States, 46260
United States, Missouri
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Creve Coeur, Missouri, United States, 63141
United States, New Jersey
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Princeton, New Jersey, United States, 08540
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Willingboro, New Jersey, United States, 08046
United States, New York
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Brooklyn, New York, United States, 11235
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Cedarhurst, New York, United States, 11516
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Fresh Meadows, New York, United States, 11366
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Rochester, New York, United States, 14615
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Staten Island, New York, United States, 10312
United States, North Carolina
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Charlotte, North Carolina, United States, 28211
United States, Ohio
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Beachwood, Ohio, United States, 44122
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Canton, Ohio, United States, 44718
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
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Eugene, Oregon, United States, 97401
United States, Pennsylvania
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Allentown, Pennsylvania, United States, 18104
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Philadelphia, Pennsylvania, United States, 19139
United States, Texas
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Austin, Texas, United States, 78754
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Desoto, Texas, United States, 75115
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Wharton, Texas, United States, 77488
United States, Virginia
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Richmond, Virginia, United States, 23230
United States, Washington
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Bellevue, Washington, United States, 98007
Austria
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Vienna, Austria, 1010
Belgium
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Liège, Belgium, 4000
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Ottignies, Belgium, 1340
France
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Douai, France, 59500
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Limoges, France, 87025
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Nimes, France, 30029
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Toulon, France, 83506
Germany
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Dresden, Germany, 01307
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Oranienburg, Germany, 16515
Poland
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Bialystok, Poland, 15-879
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Gdynia, Poland, 81-361
Puerto Rico
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San Juan, Puerto Rico, 00926
Romania
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Bucharest, Romania, 041914
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Targu Mures, Romania, 540139
Spain
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Madrid, Spain, 28031
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Sevilla, Spain, 41700
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Vic, Spain, 08500
Sweden
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Lulea, Sweden, SE 972 35
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Malmo, Sweden, 21153
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01328093     History of Changes
Other Study ID Numbers: 14211, H8Y-MC-HBDE
Study First Received: March 31, 2011
Last Updated: January 11, 2013
Health Authority: United States: Food and Drug Administration
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Ethics Committee
France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 17, 2014