SchizophreniaPhase 2NCT00520923

A Study for Participants With Schizophrenia

A Phase 2 study testing LY2140023 and Olanzapine in people with Schizophrenia, run by Denovo Biopharma LLC at 35 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to test the hypothesis that 1 or more dose levels of LY2140023 given orally to participants with schizophrenia twice daily for 4 weeks will have significantly greater effect than placebo. 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 and Olanzapine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 669 participants
Where: 35 sitesin 9 countries
Study dates: Sep 2007to Oct 2008
Phase: Phase 2
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

Some Inclusion Criteria:

Participants must have a diagnosis of Schizophrenia as defined in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (Disorganized, 295.10; Catatonic, 295.20; Paranoid, 295.30; Residual, 295.60; or Undifferentiated, 295.90) and confirmed by the Structured Clinical Interview for DSM-IV (SCID).
Participants must meet the following psychopathologic severity criteria at Visit 1: Brief Psychiatric Rating Scale (BPRS) total score, extracted from the Positive and Negative Syndrome Scale (PANSS), of at least 45 (18-item version, in which 1 indicates "absent" and 7 indicates "severe"). In addition, item scores of at least 4 (moderate) will be required on 2 of the following BPRS items: conceptual disorganization, suspiciousness, hallucinatory behavior, and/or unusual thought content.
Participants must receive a rating of 4 (moderately ill) or greater on the Clinical Global Impression-Severity (CGI-S) scale at Visit 1.
Participants in whom, in the opinion of the investigator, a switch to another antipsychotic medication or initiation of an antipsychotic medication is acutely indicated.

Some Exclusion Criteria:

Participants in whom treatment with olanzapine or placebo is relatively or absolutely clinically contraindicated.
Participants who have a history of inadequate response to an adequate treatment trial with olanzapine, in the opinion of the investigator.
Participants who have received treatment with olanzapine within 6 weeks prior to Visit 1.
Participants who have received treatment with clozapine at doses greater than 200 mg daily within 12 months prior to Visit 1, or who have received any clozapine at all during the month before Visit 1.
Participants who have a history of an inadequate response, in the opinion of the investigator, to 2 or more adequate antipsychotic medication trials of at least 8 weeks duration in the past 12 months prior to Visit 1.
Participants with acute, serious, or unstable medical conditions, including (but not limited to) inadequately controlled diabetes (hemoglobin A1c (HbA1c) 8%), severe hypertriglyceridemia (fasting triglycerides 5.6 millimoles per litre (mmol/L), recent cerebrovascular accidents, serious acute systemic infection or immunologic disease, unstable cardiovascular disorders (including ischemic heart disease), malnutrition, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, or hematologic diseases.

Trial locations and contacts

35 sites in 9 countries.

Country

City, postcode or hospital

35 sites in 9 countries

Russia8 sites

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.
Kazan', 420012
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Khot'kovo, 127025
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Lipetsk, 399007
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Moscow, 123367
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Nikol’skoye, 188357
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Nizhny Novgorod, 603155
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Saint Petersburg, 190121
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Samara, 443016

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South Africa6 sites

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Bloemfontein, 9300
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Cape Town, 7530
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Durban, 4000
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Johannesburg, 2198
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Pretoria, 0181
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Randburg, 2125

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Argentina4 sites

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Banfield, B1828CKR
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Buenos Aires, C1424CAB
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Lanus, B18241BR
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Munro, 1605

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Germany4 sites

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Aachen, D-52057
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Bochum, 44791
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Dresden, 01307
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München, D-81675

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Romania4 sites

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.
Bucharest, 73120
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Craiova, 200738
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Iași, 700282
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Târgu Mureş, 540139

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Croatia3 sites

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Osijek, HR-31000
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Split, 21000
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Zagreb, HR-10090

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Austria2 sites

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Graz, 8036
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Vienna, 1090

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Mexico2 sites

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.
Mexico City, 14420
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Monterrey, 64000

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Portugal2 sites

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.
Lisbon, 1350-190
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Porto, 4200-272

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About this study

Official title: A Multi-Center, Inpatient, Phase 2, Double-blind, Placebo-Controlled Dose Ranging Study of LY2140023 in Patients With DSM-IV Schizophrenia

Read the detailed description

The primary objective of this study was to test the hypothesis that 1 or more dose levels of LY2140023 given orally to patients with schizophrenia twice daily for 4 weeks would demonstrate significantly greater efficacy than placebo. Efficacy was defined as clinical response measured by the Positive and Negative Syndrome Scale (PANSS) total score as assessed at 4 weeks.

This was a multi-center, randomized, double-blind, parallel, placebo- and active comparator-controlled trial with 4 study periods. Approximately 870 patients who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV, APA 2000) criteria for schizophrenia as defined by the modified Structured Clinical Interview for DSM-IV Diagnosis (SCID) were to be entered into the study so that approximately 550 patients would be considered evaluable (that is, randomized patients with a baseline and at least 1 postbaseline PANSS total score following study treatment). Male and female patients aged 18 to 65 years who qualified for enrollment into the study were randomized in a 2:2:2:2:2:1 ratio to receive 5 mg, 20 mg, 40 mg, or 80 mg twice daily LY2140023, placebo twice daily, or placebo once each morning and 15 mg olanzapine once each evening for approximately 28 days.

Conditions: Schizophrenia
Being tested: LY2140023, Olanzapine, Placebo
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 Pomaglumetad Methionil
Administered orally
OlanzapineDrug
Administered orally
PlaceboDrug
Administered orally

Study groups in NCT00520923
Study group	Role	What they receive
Placebo for LY2140023	Placebo comparator	Placebo for LY2140023 taken orally twice daily for up to 4 weeks. Receives: Drug: Placebo
10 mg LY2140023	Experimental	10 milligram (mg) LY2140023 taken orally as 5 mg twice daily for up to 4 weeks. Receives: Drug: LY2140023
40 mg LY2140023	Experimental	40 mg LY2140023 taken orally as 20 mg twice daily for up to 4 weeks. Receives: Drug: LY2140023
80 mg LY2140023	Experimental	80 mg LY2140023 taken orally as 40 mg twice daily for up to 4 weeks. Receives: Drug: LY2140023
160 mg LY2140023	Experimental	160 mg LY2140023 taken orally as 80 mg twice daily for up to 4 weeks. Receives: Drug: LY2140023
Placebo/15 mg Olanzapine	Active comparator	Placebo: Taken orally every morning (QAM), followed by Olanzapine 15 mg taken orally every evening (QPM) for up to 4 weeks. Olanzapine: 10 mg PO (by mouth) QPM for the first 3 days, then 15mg PO QPM for up to 4 weeks. Receives: Drug: Olanzapine; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Positive and Negative Syndrome Scale (PANSS) total score
Measured: over 4 weeks of treatment

Secondary outcomes (8)

PANSS subscores: positive subscore; negative subscore; general psychopathology subscore and cognitive subscore
Measured: over 4 weeks of treatment
Clinical Global Impression-Severity (CGI-S)
Measured: over 4 weeks of treatment
Drug Attitude Inventory-10 (DAI-10)
Measured: over 4 weeks of treatment
Response and Remission Rates
Measured: over 4 weeks of treatment
Assessment of Cognition in Schizophrenia (BACS) Symbol Coding Task
Measured: over 4 weeks of treatment
Montgomery-Asberg Depression RatingScale (MADRS)
Measured: over 4 weeks of treatment
Safety and Tolerability
Measured: over 4 weeks of treatment
Pharmacokinetics
Measured: over 4 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2007Oct 2008

First posted27 Aug 2007 (estimated)
Study startSep 2007
Primary completionOct 2008
Study completionOct 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 669 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00520923
Sponsor's protocol ID: 11757
Other IDs: H8Y-MC-HBBI
Status last verified: Aug 2022
First submitted: 24 Aug 2007
Last updated: 14 Sep 2026
Results posted: No
Data monitoring committee: No

Publications

Kinon BJ, Millen BA, Zhang L, McKinzie DL. Exploratory analysis for a targeted patient population responsive to the metabotropic glutamate 2/3 receptor agonist pomaglumetad methionil in schizophrenia. Biol Psychiatry. 2015 Dec 1;78(11):754-62. doi: 10.1016/j.biopsych.2015.03.016. Epub 2015 Mar 19.
PubMed 25890643

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Supporting Patients by Family Education in Psychotic Illness: A Prospective Cohort Study
Psychotic Disorders, Family Members
RecruitingObservational study
The ATP Project (Antipsychotic-TEP-Psychosis)
First Episose Psychosis, Metabolic Disease
RecruitingPhase 2
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Schizophrenia
Recruiting
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All Schizophrenia trials

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 Multi-Center, Inpatient, Phase 2, Double-blind, Placebo-Controlled Dose Ranging Study of LY2140023 in Patients With DSM-IV Schizophrenia
ClinicalTrials.gov ID: NCT00520923
Acronym / sponsor ID: 11757
Conditions: Schizophrenia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 669 participants (actual)
Lead sponsor: Denovo Biopharma LLCIndustry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 27 Aug 2007 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 6

Arm	Type	Receives
Placebo for LY2140023	Placebo comparator	Drug: PlaceboPlacebo for LY2140023 taken orally twice daily for up to 4 weeks.
10 mg LY2140023	Experimental	Drug: LY214002310 milligram (mg) LY2140023 taken orally as 5 mg twice daily for up to 4 weeks.
40 mg LY2140023	Experimental	Drug: LY214002340 mg LY2140023 taken orally as 20 mg twice daily for up to 4 weeks.
80 mg LY2140023	Experimental	Drug: LY214002380 mg LY2140023 taken orally as 40 mg twice daily for up to 4 weeks.
160 mg LY2140023	Experimental	Drug: LY2140023160 mg LY2140023 taken orally as 80 mg twice daily for up to 4 weeks.
Placebo/15 mg Olanzapine	Active comparator	Drug: Olanzapine, Drug: PlaceboPlacebo: Taken orally every morning (QAM), followed by Olanzapine 15 mg taken orally every evening (QPM) for up to 4 weeks. Olanzapine: 10 mg PO (by mouth) QPM for the first 3 days, then 15mg PO QPM for up to 4 weeks.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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: Pomaglumetad MethionilAdministered orally	Drug	10 mg LY2140023, 160 mg LY2140023, 40 mg LY2140023, 80 mg LY2140023
OlanzapineAdministered orally	Drug	Placebo/15 mg Olanzapine
PlaceboAdministered orally	Drug	Placebo for LY2140023, Placebo/15 mg Olanzapine

Primary outcome

Positive and Negative Syndrome Scale (PANSS) total score
Time frame: over 4 weeks of treatment

8 secondary outcomes

PANSS subscores: positive subscore; negative subscore; general psychopathology subscore and cognitive subscore
Time frame: over 4 weeks of treatment
Clinical Global Impression-Severity (CGI-S)
Time frame: over 4 weeks of treatment
Drug Attitude Inventory-10 (DAI-10)
Time frame: over 4 weeks of treatment
Response and Remission Rates
Time frame: over 4 weeks of treatment
Assessment of Cognition in Schizophrenia (BACS) Symbol Coding Task
Time frame: over 4 weeks of treatment
Montgomery-Asberg Depression RatingScale (MADRS)
Time frame: over 4 weeks of treatment
Safety and Tolerability
Time frame: over 4 weeks of treatment
Pharmacokinetics
Time frame: over 4 weeks of treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
Derived from this study: PubMed 25890643Kinon BJ, Millen BA, Zhang L, McKinzie DL. Exploratory analysis for a targeted patient population responsive to the metabotropic glutamate 2/3 receptor agonist pomaglumetad methionil in schizophrenia. Biol Psychiatry. 2015 Dec 1;78(11):754-62. doi: 10.1016/j.biopsych.2015.03.016. Epub 2015 Mar 19.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Schizophrenia

Recruiting
Supporting Patients by Family Education in Psychotic Illness: A Prospective Cohort Study
Psychotic Disorders, Family Members
RecruitingObservational study
The ATP Project (Antipsychotic-TEP-Psychosis)
First Episose Psychosis, Metabolic Disease
RecruitingPhase 2
Combination of NMDA-enhancing and Antioxidant Treatments for Schizophrenia
Schizophrenia
Recruiting
Interest of the Tool: Evaluation of Specific Care in an Ecological Environment for Patients Suffering From Schizophrenia-like Disorders
Patients With Schizophrenia-like Disorders
RecruitingPhase 2
NMDA-enhancing Treatment for Cognitive Dysfunction of Schizophrenia
Schizophrenia

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

35 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY2140023 and Olanzapine in people with Schizophrenia, run by Denovo Biopharma LLC at 35 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?

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: finished, 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 35 sites in Russia, South Africa, Argentina, Germany, Romania 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Positive and Negative Syndrome Scale (PANSS) total score (time frame: over 4 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00520923, which also lists 1 linked publication.

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.