SchizophreniaPhase 2/3NCT01129674
A Long-Term, Open-Label, Study on Schizophrenia
A Phase 2/3 study testing LY2140023, Olanzapine and Aripiprazole in people with Schizophrenia, run by Denovo Biopharma LLC at 81 sites in 9 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- LY2140023, Olanzapine and Aripiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 81 sitesin 9 countries
- Study dates
- Jun 2010to Oct 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 participants of childbearing potential must agree to use a single, effective, medically acceptable method of birth control.
- Participants must be considered reliable and have a level of understanding sufficient to perform all tests and examinations required by the protocol.
- Participants must be able to understand the nature of the study and have given their own informed consent.
Who cannot join
- 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.
- Participants for whom treatment with olanzapine, risperidone, aripiprazole, quetiapine, or LY2140023, as specified in this protocol, is relatively or absolutely clinically contraindicated.
- Participants 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.
- Participants who require concomitant treatment with any other medication with primary central nervous system activity, other than those allowed in study protocol.
- Participants have risk of suicide.
- Participants diagnosed with substance dependence or substance abuse within the 6 months prior to study enrollment.
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- Participants diagnosed with substance-induced psychosis within 7 days of study enrollment or at any time during the study.
- Female participants 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.
- Participants who have had electroconvulsive therapy (ECT) within 3 months of study enrollment or who will have ECT at any time during the study.
- Participants with known Human Immunodeficiency Virus positive (HIV+) status.
- Participants have a serious disease, such as recent stroke, heart, liver, kidney, lung or blood diseases
- Participants with Parkinson's disease
- Are incapable of participating in the study or are unwilling to engage in a meaningful way as study participants.
Trial locations and contacts
81 sites in 9 countries.
81 sites in 9 countries
United States42 sites
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Atlanta, Georgia, 30308
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Austin, Texas, 78754
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Buffalo, New York, 14215
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Cedarhurst, New York, 11516
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Chicago, Illinois, 60640
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Cincinnati, Ohio, 45219
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Creve Coeur, Missouri, 63141
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Dallas, Texas, 75243
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Dayton, Ohio, 45417
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DeSoto, Texas, 75115
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Escondido, California, 92025
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Flowood, Mississippi, 39232
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Fort Lauderdale, Florida, 33308
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Garden Grove, California, 92845
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Hoffman Estates, Illinois, 60169
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Holliswood, New York, 11423
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Hollywood, Florida, 33021
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Houston, Texas, 77008
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Indianapolis, Indiana, 46222
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Kissimmee, Florida, 34741
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Lake Charles, Louisiana, 70629
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Little Rock, Arkansas, 72201
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Long Beach, California, 90813
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Maitland, Florida, 32751
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Marlton, New Jersey, 08053
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National City, California, 91950
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New York, New York, 10032
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Oakland, California, 94612
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Oceanside, California, 92056
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Paramount, California, 90723
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Pasadena, California, 91106
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Philadelphia, Pennsylvania, 19139
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Richmond, Virginia, 23298
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Roanoke, Virginia, 24014
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Rochester, New York, 14615
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San Diego, California, 92123
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Sherman Oaks, California, 91403
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Shreveport, Louisiana, 71104
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Torrance, California, 90502
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University Park, Florida, 34201
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Washington D.C., District of Columbia, 20016
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Wichita, Kansas, 67207
Japan11 sites
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Aichi, 470-1168
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Kanagawa, 210-0013
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Kumamoto, 861-0002
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Kyoto, 625-8502
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Nagano, 384-8540
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Nagasaki, 856-0847
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Nara, 634-8522
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Osaka, 569-1041
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Saga, 842-0192
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Tokyo, 120-0033
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Toyama, 939-8073
Russia10 sites
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Khot'kovo, 127025
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Lipetsk, 399007
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Moscow, 115522
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Nizhny Novgorod, 603155
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Saint Petersburg, 190121
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Samara, 443016
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Saratov, 410060
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Tomsk, 634014
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Voronezh, 394071
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Yaroslavl, 150003
South Korea6 sites
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Goyang-si, 410-719
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Incheon, 400-711
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Naju, 520-833
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Seoul, 150-713
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Suwon, 442-723
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Yŏngin, 446-769
Ukraine4 sites
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Donetsk, 83037
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Kherson, 73488
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Kiev, 2660
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Vinnytsia, 21005
Taiwan3 sites
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Changhua, 50550
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Neihu District, 114
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Taipei, 100
Mexico2 sites
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Guadalajara, 44340
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Monterrey, 64060
Puerto Rico2 sites
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Ponce, 00731
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San Juan, 00926
Croatia1 site
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Zagreb, 10090
About this study
Official title: 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.
Read the detailed description
The study includes 2 treatment periods. Study Period I will begin at participant randomization (enrollment into Study HBBO) and continue through the first 2 years of treatment. Study Period II will be only for participants randomized to treatment with LY2140023, and will begin after the participant has completed the second year of treatment. Participants 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.
- Conditions
- Schizophrenia
- Being tested
- LY2140023, Olanzapine, Aripiprazole, Risperidone, Quetiapine
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2140023Drug
Also called metabotropic glutamate (mGlu) 2/3 Prodrug II
Administered orally, twice daily for 104 weeks
OlanzapineDrug
Also called Zyprexa, LY170053
Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks
AripiprazoleDrug
Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks
RisperidoneDrug
Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks
QuetiapineDrug
Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Not described Receives: Drug: Olanzapine; Drug: Aripiprazole; Drug: Risperidone; Drug: Quetiapine |
| LY2140023 | Experimental | 20 milligram (mg), 40mg or 80mg
After 104 weeks, participants have the option to continue on treatment until the end of the study Receives: Drug: LY2140023 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to discontinuation due to adverse events
Measured: Baseline through 52 weeks
Secondary outcomes (17)
Change from baseline to 52 weeks endpoint in PANSS (Positive and Negative Syndrome Scale)
Measured: Baseline, 52 weeks
Change from baseline to 52 week endpoint in Clinical Global Impression-Severity (CGI-S)
Measured: Baseline, 52 weeks
Change from baseline to 52 week endpoint in NSA-16 (16-item Negative Symptoms Assessment)
Measured: 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)
Measured: 52 weeks, 104 weeks, end of study
Change from baseline to 52 week endpoint in PSP scale (Personal and Social Performance)
Measured: Baseline, 52 weeks
Change from baseline to 52 week endpoint in the SWN Scale (Subjective Well-Being Under Neuroleptic Treatment)
Measured: Baseline, 52 weeks
Change from baseline to 104 week endpoint in the Schizophrenia Resource Use Model (S-RUM)
Measured: Baseline, 104 weeks
Change from baseline to 104 week endpoint in the EuroQoL Questionnaire-5 Dimension (EQ-5D)
Measured: Baseline, 104 weeks
Change from 52 week to 104 week endpoint in PANSS (Positive and Negative Syndrome Scale)
Measured: 52 weeks, 104 weeks
Change from 52 week to 104 week endpoint in Clinical Global Impression-Severity (CGI-S)
Measured: 52 weeks, 104 weeks
Change from 52 week to 104 week endpoint in NSA-16 (16-item Negative Symptoms Assessment)
Measured: 52 weeks, 104 weeks
Change from 104 week to study endpoint in Clinical Global Impression-Severity (CGI-S)
Measured: 104 weeks, end of study
Change from baseline to 104 week endpoint in PSP scale (Personal and Social Performance)
Measured: Baseline, 104 weeks
Change from baseline to 104 week endpoint in the SWN Scale (Subjective Well-Being Under Neuroleptic Treatment)
Measured: Baseline, 104 weeks
Change from Baseline to 52 week endpoint in the Schizophrenia Resource Use Model (S-RUM)
Measured: Baseline, 52 weeks
Change from 104 week to study endpoint in the EuroQoL Questionnaire-5 Dimension (EQ-5D)
Measured: 104 weeks, end of study
Change from baseline to 52 weeks endpoint in PANSS (Positive and Negative Syndrome Scale) in a genetically defined subgroup
Measured: Baseline, 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: The decision to stop the trial was based on efficacy results in the overall schizophrenia participant population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denovo Biopharma LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129674
- Sponsor's protocol ID
- 11960
- Other IDs
- H8Y-MC-HBBO
- Status last verified
- Oct 2022
- First submitted
- 21 May 2010
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term, Open-Label, Multicenter Study of LY2140023 Compared to Atypical Antipsychotic Standard of Care in Patients With DSM-IV-TR Schizophrenia
- ClinicalTrials.gov ID
- NCT01129674
- Acronym / sponsor ID
- 11960
- Conditions
- Schizophrenia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The decision to stop the trial was based on efficacy results in the overall schizophrenia participant population.
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Denovo Biopharma LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 25 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study includes 2 treatment periods. Study Period I will begin at participant randomization (enrollment into Study HBBO) and continue through the first 2 years of treatment. Study Period II will be only for participants randomized to treatment with LY2140023, and will begin after the participant has completed the second year of treatment. Participants 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Drug: Olanzapine, Drug: Aripiprazole, Drug: Risperidone, Drug: Quetiapine |
| LY2140023 | Experimental | Drug: LY214002320 milligram (mg), 40mg or 80mg After 104 weeks, participants have the option to continue on treatment until the end of the study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 participants of childbearing potential must agree to use a single, effective, medically acceptable method of birth control.
- Participants must be considered reliable and have a level of understanding sufficient to perform all tests and examinations required by the protocol.
- Participants must be able to understand the nature of the study and have given their own informed consent.
Key exclusion criteria (16 listed)
- 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.
- Participants for whom treatment with olanzapine, risperidone, aripiprazole, quetiapine, or LY2140023, as specified in this protocol, is relatively or absolutely clinically contraindicated.
- Participants 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.
- Participants who require concomitant treatment with any other medication with primary central nervous system activity, other than those allowed in study protocol.
- Participants have risk of suicide.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY2140023Also: metabotropic glutamate (mGlu) 2/3 Prodrug IIAdministered orally, twice daily for 104 weeks | Drug | LY2140023 |
| OlanzapineAlso: Zyprexa, LY170053Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks | Drug | Standard of Care |
| AripiprazoleTablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks | Drug | Standard of Care |
| RisperidoneTablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks | Drug | Standard of Care |
| QuetiapineTablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks | Drug | Standard of Care |
Primary outcome
Time to discontinuation due to adverse events
Time frame: Baseline through 52 weeks
17 secondary outcomes
Change from baseline to 52 weeks endpoint in PANSS (Positive and Negative Syndrome Scale)
Time frame: Baseline, 52 weeks
Change from baseline to 52 week endpoint in Clinical Global Impression-Severity (CGI-S)
Time frame: Baseline, 52 weeks
Change from baseline to 52 week endpoint in NSA-16 (16-item Negative Symptoms Assessment)
Time frame: 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)
Time frame: 52 weeks, 104 weeks, end of study
Change from baseline to 52 week endpoint in PSP scale (Personal and Social Performance)
Time frame: Baseline, 52 weeks
Change from baseline to 52 week endpoint in the SWN Scale (Subjective Well-Being Under Neuroleptic Treatment)
Time frame: Baseline, 52 weeks
Change from baseline to 104 week endpoint in the Schizophrenia Resource Use Model (S-RUM)
Time frame: Baseline, 104 weeks
Change from baseline to 104 week endpoint in the EuroQoL Questionnaire-5 Dimension (EQ-5D)
Time frame: Baseline, 104 weeks
Change from 52 week to 104 week endpoint in PANSS (Positive and Negative Syndrome Scale)
Time frame: 52 weeks, 104 weeks
Change from 52 week to 104 week endpoint in Clinical Global Impression-Severity (CGI-S)
Time frame: 52 weeks, 104 weeks
Change from 52 week to 104 week endpoint in NSA-16 (16-item Negative Symptoms Assessment)
Time frame: 52 weeks, 104 weeks
Change from 104 week to study endpoint in Clinical Global Impression-Severity (CGI-S)
Time frame: 104 weeks, end of study
Change from baseline to 104 week endpoint in PSP scale (Personal and Social Performance)
Time frame: Baseline, 104 weeks
Change from baseline to 104 week endpoint in the SWN Scale (Subjective Well-Being Under Neuroleptic Treatment)
Time frame: Baseline, 104 weeks
Change from Baseline to 52 week endpoint in the Schizophrenia Resource Use Model (S-RUM)
Time frame: Baseline, 52 weeks
Change from 104 week to study endpoint in the EuroQoL Questionnaire-5 Dimension (EQ-5D)
Time frame: 104 weeks, end of study
Change from baseline to 52 weeks endpoint in PANSS (Positive and Negative Syndrome Scale) in a genetically defined subgroup
Time frame: Baseline, 52 Weeks
Results and safety
The study was stopped early (reason given: The decision to stop the trial was based on efficacy results in the overall schizophrenia participant population.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
81 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing LY2140023, Olanzapine and Aripiprazole in people with Schizophrenia, run by Denovo Biopharma LLC at 81 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 81 sites in United States, Japan, Russia, South Korea, Ukraine and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The decision to stop the trial was based on efficacy results in the overall schizophrenia participant population.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to discontinuation due to adverse events (time frame: Baseline through 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.