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

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.

Study Overview

• Status: Terminated
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Olanzapine; Drug: Aripiprazole; Drug: Risperidone; Drug: Quetiapine; Drug: LY2140023

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1210
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Croatia
  • Zagreb, Croatia, 10090
    • 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.
• Japan
  • Aichi, Japan, 470-1168
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  • Kanagawa, Japan, 210-0013
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  • Kumamoto, Japan, 861-0002
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  • Kyoto, Japan, 625-8502
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  • Nagano, Japan, 384-8540
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  • Nagasaki, Japan, 856-0847
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  • Nara, Japan, 634-8522
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  • Osaka, Japan, 569-1041
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  • Saga, Japan, 842-0192
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  • Tokyo, Japan, 120-0033
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  • Toyama, Japan, 939-8073
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• Korea, Republic of
  • Goyang-Si, Korea, Republic of, 410-719
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  • Incheon, Korea, Republic of, 400-711
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  • Naju, Korea, Republic of, 520-833
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  • Seoul, Korea, Republic of, 150-713
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  • Suwon-City, Korea, Republic of, 442-723
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  • Yongin, Korea, Republic of, 446-769
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• Mexico
  • Guadalajara, Mexico, 44340
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  • Monterrey, Mexico, 64060
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• Puerto Rico
  • Ponce, Puerto Rico, 00731
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  • San Juan, Puerto Rico, 00926
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• Russian Federation
  • Khotkovo, Russian Federation, 127025
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  • Lipetsk, Russian Federation, 399007
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  • Moscow, Russian Federation, 115522
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  • Nizhniy Novgorod, Russian Federation, 603155
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  • Saint Petersburg, Russian Federation, 190121
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  • Samara, Russian Federation, 443016
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  • Saratov, Russian Federation, 410060
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  • Tomsk, Russian Federation, 634014
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  • Voronezh, Russian Federation, 394071
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  • Yaroslavl, Russian Federation, 150003
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• Taiwan
  • Changhua, Taiwan, 50550
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  • Neihu Taipei, Taiwan, 114
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  • Taipei, Taiwan, 100
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• Ukraine
  • Donetsk, Ukraine, 83037
    • 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.
  • Kherson, Ukraine, 73488
    • 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.
  • Kiev, Ukraine, 2660
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  • Vinnytsya, Ukraine, 21005
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• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72201
      • 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.
  • California
    • 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
      • 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.
    • National City, California, United States, 91950
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    • Oakland, California, United States, 94612
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    • Oceanside, California, United States, 92056
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    • Paramount, California, United States, 90723
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    • Pasadena, California, United States, 91106
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    • San Diego, California, United States, 92123
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    • Sherman Oaks, California, United States, 91403
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    • Torrance, California, United States, 90502
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  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • 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.
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
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    • Hollywood, Florida, United States, 33021
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    • Kissimmee, Florida, United States, 34741
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    • Maitland, Florida, United States, 32751
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    • University Park, Florida, United States, 34201
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  • Georgia
    • Atlanta, Georgia, United States, 30308
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  • Illinois
    • Chicago, Illinois, United States, 60640
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    • Hoffman Estates, Illinois, United States, 60169
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  • Indiana
    • Indianapolis, Indiana, United States, 46222
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  • Kansas
    • Wichita, Kansas, United States, 67207
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  • Louisiana
    • Lake Charles, Louisiana, United States, 70629
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    • Shreveport, Louisiana, United States, 71104
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  • Mississippi
    • Flowood, Mississippi, United States, 39232
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  • Missouri
    • Creve Coeur, Missouri, United States, 63141
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  • New Jersey
    • Marlton, New Jersey, United States, 08053
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  • New York
    • Buffalo, New York, United States, 14215
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    • Cedarhurst, New York, United States, 11516
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    • Holliswood, New York, United States, 11423
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    • New York, New York, United States, 10032
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    • Rochester, New York, United States, 14615
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  • Ohio
    • Cincinnati, Ohio, United States, 45219
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    • Dayton, Ohio, United States, 45417
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  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19139
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  • Texas
    • Austin, Texas, United States, 78754
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    • Dallas, Texas, United States, 75243
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    • Desoto, Texas, United States, 75115
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    • Houston, Texas, United States, 77008
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  • Virginia
    • Richmond, Virginia, United States, 23298
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    • Roanoke, Virginia, United States, 24014
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Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.
• Have seizure liability inconsistent with the exclusion criteria of the completed acute feeder study.
• Patients who have had electroconvulsive therapy (ECT) within 3 months of study enrollment or who will have ECT at any time during the study.
• Patients with known Human Immunodeficiency Virus positive (HIV+) status.
• Patients have a serious disease, such as recent stroke, heart, liver, kidney, lung or blood diseases
• Patients with Parkinson's disease
• Are incapable of participating in the study or are unwilling to engage in a meaningful way as study participants.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Standard of Care	Drug: Olanzapine; Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks; Other Names: Zyprexa; LY170053; Drug: Aripiprazole; Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks; Drug: Risperidone; Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks; Drug: Quetiapine; Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks
EXPERIMENTAL: LY2140023; 20mg, 40mg or 80mg After 104 weeks, patients have the option to continue on treatment until the end of the study	Drug: LY2140023; Administered orally, twice daily for 104 weeks; Other Names: mGlu 2/3 Prodrug II

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to discontinuation due to adverse events	Baseline through 52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to 52 weeks endpoint in PANSS (Positive and Negative Syndrome Scale)	Baseline, 52 weeks
Change from baseline to 52 week endpoint in Clinical Global Impression-Severity (CGI-S)	Baseline, 52 weeks
Change from baseline to 52 week endpoint in NSA-16 (16-item Negative Symptoms Assessment)	Baseline, 52 weeks
The number of patients with statistically significant changes (treatment emergent ideation and behavior; improvement) based on the Columbia Suicide Severity Rating Scale (C-SSRS)	52 weeks, 104 weeks, end of study
Change from baseline to 52 week endpoint in PSP scale (Personal and Social Performance)	Baseline, 52 weeks
Change from baseline to 52 week endpoint in the SWN Scale (Subjective Well-Being Under Neuroleptic Treatment)	Baseline, 52 weeks
Change from baseline to 104 week endpoint in the Schizophrenia Resource Use Model (S-RUM)	Baseline, 104 weeks
Change from baseline to 104 week endpoint in the EuroQoL Questionnaire-5 Dimension (EQ-5D)	Baseline, 104 weeks
Change from 52 week to 104 week endpoint in PANSS (Positive and Negative Syndrome Scale)	52 weeks, 104 weeks
Change from 52 week to 104 week endpoint in Clinical Global Impression-Severity (CGI-S)	52 weeks, 104 weeks
Change from 52 week to 104 week endpoint in NSA-16 (16-item Negative Symptoms Assessment)	52 weeks, 104 weeks
Change from 104 week to study endpoint in Clinical Global Impression-Severity (CGI-S)	104 weeks, end of study
Change from baseline to 104 week endpoint in PSP scale (Personal and Social Performance)	Baseline, 104 weeks
Change from baseline to 104 week endpoint in the SWN Scale (Subjective Well-Being Under Neuroleptic Treatment)	Baseline, 104 weeks
Change from Baseline to 52 week endpoint in the Schizophrenia Resource Use Model (S-RUM)	Baseline, 52 weeks
Change from 104 week to study endpoint in the EuroQoL Questionnaire-5 Dimension (EQ-5D)	104 weeks, end of study
Change from baseline to 52 weeks endpoint in PANSS (Positive and Negative Syndrome Scale) in a genetically defined subgroup	Baseline, 52 Weeks

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: May 21, 2010
• First Submitted That Met QC Criteria: May 21, 2010
• First Posted (ESTIMATE): May 25, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): January 21, 2013
• Last Update Submitted That Met QC Criteria: January 11, 2013
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Olanzapine; Aripiprazole; Quetiapine Fumarate; Risperidone
• Other Study ID Numbers: 11960 (Other Identifier: DAIDS-ES Registry Number); H8Y-MC-HBBO (OTHER: Eli Lilly and Company)