SchizophreniaPhase 2NCT01086748

A Comparator Study of LY2140023 Versus Placebo in Schizophrenia Patients

A Phase 2 study testing Risperidone and LY2140023 in people with Schizophrenia, run by Denovo Biopharma LLC at 28 sites in 3 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

An inpatient/outpatient study to see if LY2140023 is better than placebo in acutely ill 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?: Risperidone and LY2140023
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,134 participants
Where: 28 sitesin 3 countries
Study dates: Mar 2010to May 2012
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

Who may be able to join

Diagnosis of schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR; APA 2000) (Disorganized, 295.10; Catatonic, 295.20; Paranoid 295.30; or Undifferentiated, 295.90) and confirmed by the Structured Clinical Interview for DSM-IV-TR (SCID).
Non-pregnant female patients who agree to use acceptable birth control.
At entry to the study, must be considered at least moderately ill in the opinion of the investigator.
Willing to participate in a minimum of 3 weeks of inpatient hospitalization and this must be appropriate for the patient in the clinical judgment of the investigator.
1 year history of schizophrenia prior to entering the study.
At study entry, patients with a history of antipsychotic treatment must have a lifetime history of at least one hospitalization for the treatment of schizophrenia, not including the hospitalization required for study. Patients who have never taken antipsychotic treatment may enter the study even without a history of hospitalization.
At study entry, patients with a history of antipsychotic treatment must have a history of at least one episode of illness exacerbation requiring an intensification of treatment intervention or care in the last 2 years, not including the present episode of illness. Patients who have never taken antipsychotic treatment may enter the study without a past history of illness exacerbation and intensification of treatment in the last 2 years.
At study entry, patients must have experienced an exacerbation of illness within the 2 weeks prior to entering the study, leading to an intensification of psychiatric care in the opinion of the investigator. If exacerbation occurs in patients who are presently hospitalized, the patient must not have been hospitalized longer than 60 days at entry of the study.

Who cannot join

Participated in any clinical trial with any pharmacological treatment intervention for which they received a study-related medication in the 6 months prior to visit 1.
Previously completed or withdrawn from this study, or any other study investigating LY2140023 or any predecessor molecules with glutamatergic activity.
Treatment with clozapine at doses greater than 200 mg daily within 12 months prior to entering the study, or who have received any clozapine at all during the month before entering the study.
Patients currently receiving treatment (within 1 dosing interval, minimum of 4 weeks, prior entering the study) with a depot formulation of an antipsychotic medication.
Patients who are currently suicidal.
Females who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study.

Show all 20Show fewer

Patients with uncorrected narrow-angle glaucoma, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, uncontrolled thyroid condition or other serious or unstable illnesses.
Have a history of one or more seizures, except for those who experienced a single simple febrile seizure between ages 6 months and 5 years.
Patients are excluded if their biological father, mother, brother, sister, or child has a history of idiopathic epilepsy.
Within 1 year of study enrollment, patients have a history of central nervous system infection, uncontrolled migraine, transient ischemic attack (TIA), or head trauma with loss of consciousness or a post-concussive.
Patients are excluded if they have a lifetime history of any of the following:
head trauma, stroke, or central nervous system (CNS) infection with persistent neurological deficit (focal or diffuse);
brain surgery;
an electroencephalogram with paroxysmal (epileptiform) activity, or
brain structural lesion, including developmental abnormalities, as determined by examination or previous neuroimaging studies that are consistent with a diagnosable neurological disease or syndrome.
Electroconvulsive therapy (ECT) within 3 months of entering the study or who will have ECT at any time during the study.
Leukopenia.
Medical history of human immunodeficiency virus positive (HIV+) status.
Higher than normal blood prolactin levels.
Certain electrocardiogram results.

Trial locations and contacts

28 sites in 3 countries.

Country

City, postcode or hospital

28 sites in 3 countries

United States19 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.
Atlanta, Georgia, 30308
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.
Austin, Texas, 78754
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.
Cedarhurst, New York, 11516
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Chicago, Illinois, 60640
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Creve Coeur, Missouri, 63141
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DeSoto, Texas, 75115
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.
Escondido, California, 92025
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Flowood, Mississippi, 39232
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.
Fort Lauderdale, Florida, 33308
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.
Garden Grove, California, 92845
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Hoffman Estates, Illinois, 60169
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Hollywood, Florida, 33021
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.
Houston, Texas, 77008
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.
Lake Charles, Louisiana, 70629
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Paramount, California, 90723
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.
Philadelphia, Pennsylvania, 19131
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.
Rochester, New York, 14615
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.
Shreveport, Louisiana, 71104
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.
Washington D.C., District of Columbia, 20016

Other trials in United States

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.
Khot'kovo, 127025
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Lipetsk, 399007
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.
Moscow, 115522
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.
Nizhny Novgorod, 603155
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.
Saint Petersburg, 190121
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.
Samara, 443016
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.
Saratov, 410028
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.
Yaroslavl, 150003

Other trials in Russia

Croatia1 site

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.
Zagreb, 10090

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About this study

Official title: A Phase 2, Multicenter, Double-Blind, Placebo-Controlled Comparator Study of 2 Doses of LY2140023 Versus Placebo in Patients With DSM-IV-TR Schizophrenia

An inpatient/outpatient study to see if LY2140023 is better than placebo in acutely ill patients with schizophrenia.

Read the detailed description

Study HBBM was a multicenter, randomized, double-blind, parallel, fixed-dose, Phase 2 study to assess the efficacy and safety of 2 dose levels of LY2140023 (80 mg BID or 40 mg BID) compared to placebo in patients with schizophrenia, with a risperidone treatment arm to ensure assay sensitivity in patients with schizophrenia.

The primary objective of this study was to test the hypothesis that at least 1 dose level of LY2140023, given orally to patients with schizophrenia at 80 mg BID or 40 mg BID, would demonstrate significantly greater efficacy than placebo at Visit 9, as measured by the change from baseline in the PANSS total score.

Conditions: Schizophrenia
Being tested: Risperidone, Placebo, LY2140023
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RisperidoneDrug
Also called Risperdal
Administered orally.
PlaceboDrug
Administered orally.
LY2140023Drug
Also called Pomaglumetad methionil
Administered orally.

Study groups in NCT01086748
Study group	Role	What they receive
160 milligrams (mg) LY2140023	Experimental	An 80-mg LY2140023 tablet administered orally, twice daily (BID) for 6 weeks. Prior to randomization, participants will complete a 1-week placebo lead-in period, during which time placebo tablets identical to LY2140023 and risperidone are administered orally, BID. Receives: Drug: LY2140023
4 mg Risperidone	Active comparator	A 2-mg risperidone tablet administered orally, BID for 6 weeks. Prior to randomization, participants will complete a 1-week placebo lead-in period, during which time placebo tablets identical to LY2140023 and risperidone are administered orally, BID. Receives: Drug: Risperidone
Placebo	Placebo comparator	A placebo tablet administered orally, BID for 7 weeks. Receives: Drug: Placebo
80 mg LY2140023	Experimental	A 40-mg LY2140023 tablet administered orally, BID for 6 weeks. Prior to randomization, participants will complete a 1-week placebo lead-in period, during which time placebo tablets identical to LY2140023 and risperidone are administered orally, BID. Receives: Drug: LY2140023

What is being measured

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

A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in overall schizophrenia population
Measured: baseline, up to 7 weeks of treatment
A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in a genetic subgroup of schizophrenia patients
Measured: baseline, up to 7 weeks of treatment

Secondary outcomes (27)

A change from baseline in the Personal and Social Performance (PSP) score in the overall schizophrenia population
Measured: baseline, up to 7 weeks of treatment
A change from baseline in the Personal and Social Performance (PSP) score in a genetic subgroup of schizophrenia patients
Measured: baseline, up to 7 weeks of treatment
A change from baseline in the PANSS positive scale
Measured: baseline, up to 7 weeks of treatment
A change from baseline in the PANSS negative scale
Measured: baseline, up to 7 weeks of treatment
A change from baseline in PANSS General Psychopathology subscale
Measured: baseline, up to 7 weeks of treatment
A change from baseline in the Clinical Global Impression-Severity Scale (CGI-S)
Measured: baseline, up to 7 weeks of treatment
A change from baseline in the 16-item Negative Symptoms Assessment (NSA-16)
Measured: baseline, up to 7 weeks of treatment
A change from baseline in the Montgomery-Ǻsberg Depression Rating Scale (MADRS)
Measured: baseline, up to 7 weeks of treatment
PANSS total score
Measured: up to 7 weeks of treatment
A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in a female patients
Measured: baseline, up to 7 weeks of treatment
Rate of discontinuation
Measured: baseline, up to 7 weeks of treatment
Time to discontinuation
Measured: baseline, up to 7 weeks of treatment
A change from baseline on the EuroQol - 5 Dimensions (EQ-5D) Questionnaire
Measured: baseline, up to 7 weeks of treatment
A change from baseline on resource utilization, as measured by the Schizophrenia Resource Use Model (S-RUM)
Measured: Baseline up to 7 weeks of treatment
A change from baseline on functional capacity, as measured by the Subjective Well-Being Under Neuroleptic Treatment Scale - Short Form (SWN-S)
Measured: baseline, up to 7 weeks of treatment
A change from baseline in Barnes Akathisia Scale (BAS)
Measured: baseline, up to 7 weeks of treatment
A change from baseline in Simpson-Angus Scale (SAS)
Measured: baseline, up to 7 weeks of treatment
A change from baseline in Abnormal Involuntary Movement Scale (AIMS)
Measured: baseline, up to 7 weeks of treatment
A mean change from baseline in Prolactin levels
Measured: baseline, up to 7 weeks of treatment
A change from baseline in weight
Measured: baseline, up to 7 weeks of treatment
Number of Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 7 weeks of treatment
Change from baseline in electrocardiogram parameters
Measured: baseline, up to 7 weeks of treatment
A change from baseline in neurological examination
Measured: baseline, up to 7 weeks of treatment
Statistically different changes in vital signs from baseline
Measured: baseline, up to 7 weeks of treatment
Statistically different changes in lab values from baseline
Measured: baseline, up to 7 weeks of treatment
Population pharmacokinetics (PK) of LY2140023
Measured: baseline, up to 7 weeks of treatment
A change from baseline in Columbia- Suicide Severity Rating Scale (C-SSRS)
Measured: baseline, up to 7 weeks of treatment

Timeline

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

Mar 2010May 2012

First posted15 Mar 2010 (estimated)
Study startMar 2010
Primary completionMay 2012
Study completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,134 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01086748
Sponsor's protocol ID: 11958
Other IDs: H8Y-MC-HBBM
Status last verified: Aug 2022
First submitted: 12 Mar 2010
Last updated: 14 Sep 2026
Results posted: No
Data monitoring committee: Yes

Publications

[APA] American Psychiatric Association. Diagnostic and statistical manual of mental disorders, fourth edition. Washington DC: American Psychiatric Association; 2000.
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
Downing AM, Kinon BJ, Millen BA, Zhang L, Liu L, Morozova MA, Brenner R, Rayle TJ, Nisenbaum L, Zhao F, Gomez JC. A Double-Blind, Placebo-Controlled Comparator Study of LY2140023 monohydrate in patients with schizophrenia. BMC Psychiatry. 2014 Dec 10;14:351. doi: 10.1186/s12888-014-0351-3.
PubMed 25539791

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?

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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 Phase 2, Multicenter, Double-Blind, Placebo-Controlled Comparator Study of 2 Doses of LY2140023 Versus Placebo in Patients With DSM-IV-TR Schizophrenia
ClinicalTrials.gov ID: NCT01086748
Acronym / sponsor ID: 11958
Conditions: Schizophrenia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,134 participants (actual)
Lead sponsor: Denovo Biopharma LLCIndustry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 15 Mar 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.

An inpatient/outpatient study to see if LY2140023 is better than placebo in acutely ill patients with schizophrenia.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
160 milligrams (mg) LY2140023	Experimental	Drug: LY2140023An 80-mg LY2140023 tablet administered orally, twice daily (BID) for 6 weeks. Prior to randomization, participants will complete a 1-week placebo lead-in period, during which time placebo tablets identical to LY2140023 and risperidone are administered orally, BID.
4 mg Risperidone	Active comparator	Drug: RisperidoneA 2-mg risperidone tablet administered orally, BID for 6 weeks. Prior to randomization, participants will complete a 1-week placebo lead-in period, during which time placebo tablets identical to LY2140023 and risperidone are administered orally, BID.
Placebo	Placebo comparator	Drug: PlaceboA placebo tablet administered orally, BID for 7 weeks.
80 mg LY2140023	Experimental	Drug: LY2140023A 40-mg LY2140023 tablet administered orally, BID for 6 weeks. Prior to randomization, participants will complete a 1-week placebo lead-in period, during which time placebo tablets identical to LY2140023 and risperidone are administered orally, BID.

Who may qualify

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

Key inclusion criteria (8 listed)

Diagnosis of schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR; APA 2000) (Disorganized, 295.10; Catatonic, 295.20; Paranoid 295.30; or Undifferentiated, 295.90) and confirmed by the Structured Clinical Interview for DSM-IV-TR (SCID).
Non-pregnant female patients who agree to use acceptable birth control.
At entry to the study, must be considered at least moderately ill in the opinion of the investigator.
Willing to participate in a minimum of 3 weeks of inpatient hospitalization and this must be appropriate for the patient in the clinical judgment of the investigator.
1 year history of schizophrenia prior to entering the study.

Key exclusion criteria (20 listed)

Participated in any clinical trial with any pharmacological treatment intervention for which they received a study-related medication in the 6 months prior to visit 1.
Previously completed or withdrawn from this study, or any other study investigating LY2140023 or any predecessor molecules with glutamatergic activity.
Treatment with clozapine at doses greater than 200 mg daily within 12 months prior to entering the study, or who have received any clozapine at all during the month before entering the study.
Patients currently receiving treatment (within 1 dosing interval, minimum of 4 weeks, prior entering the study) with a depot formulation of an antipsychotic medication.
Patients who are currently suicidal.

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
RisperidoneAlso: RisperdalAdministered orally.	Drug	4 mg Risperidone
PlaceboAdministered orally.	Drug	Placebo
LY2140023Also: Pomaglumetad methionilAdministered orally.	Drug	160 milligrams (mg) LY2140023, 80 mg LY2140023

Primary outcome

A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in overall schizophrenia population
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in a genetic subgroup of schizophrenia patients
Time frame: baseline, up to 7 weeks of treatment

27 secondary outcomes

A change from baseline in the Personal and Social Performance (PSP) score in the overall schizophrenia population
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in the Personal and Social Performance (PSP) score in a genetic subgroup of schizophrenia patients
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in the PANSS positive scale
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in the PANSS negative scale
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in PANSS General Psychopathology subscale
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in the Clinical Global Impression-Severity Scale (CGI-S)
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in the 16-item Negative Symptoms Assessment (NSA-16)
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in the Montgomery-Ǻsberg Depression Rating Scale (MADRS)
Time frame: baseline, up to 7 weeks of treatment
PANSS total score
Time frame: up to 7 weeks of treatment
A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in a female patients
Time frame: baseline, up to 7 weeks of treatment
Rate of discontinuation
Time frame: baseline, up to 7 weeks of treatment
Time to discontinuation
Time frame: baseline, up to 7 weeks of treatment
A change from baseline on the EuroQol - 5 Dimensions (EQ-5D) Questionnaire
Time frame: baseline, up to 7 weeks of treatment
A change from baseline on resource utilization, as measured by the Schizophrenia Resource Use Model (S-RUM)
Time frame: Baseline up to 7 weeks of treatment
A change from baseline on functional capacity, as measured by the Subjective Well-Being Under Neuroleptic Treatment Scale - Short Form (SWN-S)
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in Barnes Akathisia Scale (BAS)
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in Simpson-Angus Scale (SAS)
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in Abnormal Involuntary Movement Scale (AIMS)
Time frame: baseline, up to 7 weeks of treatment
A mean change from baseline in Prolactin levels
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in weight
Time frame: baseline, up to 7 weeks of treatment
Number of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 7 weeks of treatment
Change from baseline in electrocardiogram parameters
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in neurological examination
Time frame: baseline, up to 7 weeks of treatment
Statistically different changes in vital signs from baseline
Time frame: baseline, up to 7 weeks of treatment
Statistically different changes in lab values from baseline
Time frame: baseline, up to 7 weeks of treatment
Population pharmacokinetics (PK) of LY2140023
Time frame: baseline, up to 7 weeks of treatment
A change from baseline in Columbia- Suicide Severity Rating Scale (C-SSRS)
Time frame: baseline, up to 7 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.
Background[APA] American Psychiatric Association. Diagnostic and statistical manual of mental disorders, fourth edition. Washington DC: American Psychiatric Association; 2000.
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.
Derived from this study: PubMed 25539791Downing AM, Kinon BJ, Millen BA, Zhang L, Liu L, Morozova MA, Brenner R, Rayle TJ, Nisenbaum L, Zhao F, Gomez JC. A Double-Blind, Placebo-Controlled Comparator Study of LY2140023 monohydrate in patients with schizophrenia. BMC Psychiatry. 2014 Dec 10;14:351. doi: 10.1186/s12888-014-0351-3.

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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

28 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Risperidone and LY2140023 in people with Schizophrenia, run by Denovo Biopharma LLC at 28 sites in 3 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 8 inclusion and 20 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: 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 28 sites in United States, Russia, Croatia. 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?

A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in overall schizophrenia population (time frame: baseline, up to 7 weeks of treatment). The study lists 2 primary outcomes in all. 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 NCT01086748, which also lists 3 linked publications.

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.