A Study in Schizophrenic Patients

A Phase 2 study testing LY2140023 in people with Schizophrenia, run by Denovo Biopharma LLC at 22 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This study is designed to compare 3 doses of LY2140023 for the treatment of schizophrenia as assessed at endpoint (up to 7 weeks) using the Clinical Utility Index (CUI), a measure of efficacy, safety, and tolerability. Read more about this study

Who is it for?: Ages 20 to 65 years
Conditions the study is for: Schizophrenia
What is being tested?: LY2140023
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 82 participants
Where: 22 sitesin 3 countries
Study dates: May 2010to Sep 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 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 participants who agree to use acceptable birth control
At entry to the study must be considered moderately ill in the opinion of the investigator
1 year history of Schizophrenia prior to entering the study
At study entry participants 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 based on the investigator's clinical judgment. Participants who have never taken antipsychotic treatment may enter the study even without a history of hospitalization
At study entry participants 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. Participants 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 participants must have experienced an exacerbation of illness within the 4 weeks prior to entering the study, leading to an intensification of psychiatric care in the opinion of the investigator. If exacerbation occurs in participants who are presently hospitalized, the participants 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
Have any known history of receiving treatment with clozapine at any dose, as determined at baseline
Have received treatment with a depot formulation of an antipsychotic medication within the 6 months prior entering the study
Participants 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

Participants with uncorrected narrow-angle glaucoma, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, untreated 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
Participants are excluded if their biological father, mother, brother, sister, or child has a history of idiopathic epilepsy
Within 1 year of study enrollment, participants 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
Participants 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

22 sites in 3 countries.

Country

City, postcode or hospital

22 sites in 3 countries

Japan12 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.
Aichi, 470-1168
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Kanagawa, 216-0003
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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, 114-0024
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Toyama, 939-8073
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Yamaguchi, 759-6321

Other trials in Japan

South Korea6 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.
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
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.
Suwon, 442-723
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.
Yŏngin, 446-769

Other trials in South Korea

Taiwan4 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.
Changhua, 50550
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.
Hsinchu, 802
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.
Taipei, 110
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.
Taipei, 114

Other trials in Taiwan

About this study

Official title: A Multicenter, Double-Blind, Placebo-Controlled Study of 3 Doses of LY2140023 in Patients With DSM-IV-TR Schizophrenia

Conditions: Schizophrenia
Being tested: LY2140023, 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
Administered orally, twice daily for up to 7 weeks of treatment
PlaceboDrug
Administered orally, twice daily for up to 7 weeks of treatment

Study groups in NCT01125358
Study group	Role	What they receive
10 milligrams (mg) LY2140023	Experimental	Not described Receives: Drug: LY2140023
80 mg LY2140023	Experimental	Not described Receives: Drug: LY2140023
160 mg LY2140023	Experimental	Not described Receives: Drug: LY2140023
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Clinical Utility Index (CUI)
CUI measures the efficacy (response), tolerability (time on treatment) and safety [incidence of adverse events (AEs)] by quantifying these 3 attributes and provides a single metric for overall treatment outcome. Each component is given a score ranging from 0 to 5. The CUI Total Score is the sum of the 3 items and ranges from 0 to 15. The greater the CUI Total Score, the more effective the treatment. If a participant experiences a drug-related seizure/death, the safety component is given a score of 0 resulting in an overall CUI Total Score of 0. Analysis of variance (ANOVA) was used to calculate Least Squares (LS) mean and standard error. LS mean values were controlled for treatment, gender and pooled investigators.
Measured: Baseline through Week 6

Secondary outcomes (5)

Change From Baseline to Week 6 Endpoint in the Positive and Negative Syndrome Scale (PANSS) Total Score, Positive Score, Negative Score, and Psychopathology Subscale
The PANSS consists of 30 items and 3 subscales designed to measure severity of psychopathology in schizophrenia. The PANSS Positive Subscale and the PANSS Negative Subscale each contain 7 items, and the remaining 16 items make up the PANSS General Psychopathology Subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). The PANSS Total Score is the sum of the 30 items (range from 30 to 210). The PANSS Positive Subscale and PANSS Negative Subscale scores each range from 7 to 49. The PANSS General Psychopathology Subscale score ranges from 16 to 112. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval. LS mean values were controlled for baseline, treatment, gender, pooled investigator, visit, treatment*visit and baseline*visit.
Measured: Baseline, Week 6
Change From Baseline to Week 6 Endpoint in the Clinical Global Impression-Severity Scale (CGI-S)
The CGI-S instrument is used to record the severity of mental illness at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval. LS mean values were controlled for baseline, treatment, gender, pooled investigator, visit, treatment*visit and baseline*visit.
Measured: Baseline, Week 6
Change From Baseline to Week 6 Endpoint in the 16-item Negative Symptoms Assessment (NSA-16)
The NSA-16 scale is used to help clinicians rate behaviors (not psychopathology) commonly associated with negative symptoms of schizophrenia. The scale rates participants on 16 "anchors". Each item ("anchor") is rated from 1 (better) to 6 (worse). The NSA-16 Total Score is the sum of the 16 specific items and ranges from 16 to 96. Higher scores indicate greater severity of illness. The Mixed Model Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval. LS mean values were controlled for baseline, treatment, gender, pooled investigator, visit, treatment*visit and baseline*visit.
Measured: Baseline, Week 6
The Number of Participants With Treatment-Emergent Suicidal Ideation and Behavior Based on the Columbia Suicide Severity Rating Scale (C-SSRS)
Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, non-fatal suicide attempt, and completed suicide. The number of participants with statistically significant changes of the C-SSRS was the number of participants with a treatment-emergent suicidal ideation and behavior (an increase in suicidal behavior or ideation over lead-in baseline.)
Measured: Baseline up to Week 6
Percentage of Participants Who Discontinued (Rate of Discontinuation)
Rate of discontinuation was calculated as the number of participants who discontinued from study due to any reason divided by the total number of participants who received study drug, then multiplied by 100.
Measured: Baseline through Week 6

Timeline

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

May 2010Sep 2012

First posted18 May 2010 (estimated)
Study startMay 2010
Primary completionSep 2012
Study completionSep 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.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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, Investigator, Outcomes assessor
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01125358
Sponsor's protocol ID: 13560
Other IDs: H8Y-JE-HBDC
Status last verified: Nov 2012
First submitted: 17 May 2010
Last updated: 14 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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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Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-Blind, Placebo-Controlled Study of 3 Doses of LY2140023 in Patients With DSM-IV-TR Schizophrenia
ClinicalTrials.gov ID: NCT01125358
Acronym / sponsor ID: 13560
Conditions: Schizophrenia
Phase: Phase 2
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: 82 participants (actual)
Lead sponsor: Denovo Biopharma LLCIndustry (pharma, biotech, devices)
Study start: May 2010
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 18 May 2010 (estimated)
Results: Posted 14 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

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

Arm	Type	Receives
10 milligrams (mg) LY2140023	Experimental	Drug: LY2140023
80 mg LY2140023	Experimental	Drug: LY2140023
160 mg LY2140023	Experimental	Drug: LY2140023
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 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 participants who agree to use acceptable birth control
At entry to the study must be considered moderately ill in the opinion of the investigator
1 year history of Schizophrenia prior to entering the study
At study entry participants 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 based on the investigator's clinical judgment. Participants who have never taken antipsychotic treatment may enter the study even without a history of hospitalization

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
Have any known history of receiving treatment with clozapine at any dose, as determined at baseline
Have received treatment with a depot formulation of an antipsychotic medication within the 6 months prior entering the study
Participants 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
LY2140023Administered orally, twice daily for up to 7 weeks of treatment	Drug	10 milligrams (mg) LY2140023, 160 mg LY2140023, 80 mg LY2140023
PlaceboAdministered orally, twice daily for up to 7 weeks of treatment	Drug	Placebo

Primary outcome

Clinical Utility Index (CUI)
Time frame: Baseline through Week 6
CUI measures the efficacy (response), tolerability (time on treatment) and safety [incidence of adverse events (AEs)] by quantifying these 3 attributes and provides a single metric for overall treatment outcome. Each component is given a score ranging from 0 to 5. The CUI Total Score is the sum of the 3 items and ranges from 0 to 15. The greater the CUI Total Score, the more effective the treatment. If a participant experiences a drug-related seizure/death, the safety component is given a score of 0 resulting in an overall CUI Total Score of 0. Analysis of variance (ANOVA) was used to calculate Least Squares (LS) mean and standard error. LS mean values were controlled for treatment, gender and pooled investigators.

5 secondary outcomes

Change From Baseline to Week 6 Endpoint in the Positive and Negative Syndrome Scale (PANSS) Total Score, Positive Score, Negative Score, and Psychopathology Subscale
Time frame: Baseline, Week 6
Change From Baseline to Week 6 Endpoint in the Clinical Global Impression-Severity Scale (CGI-S)
Time frame: Baseline, Week 6
Change From Baseline to Week 6 Endpoint in the 16-item Negative Symptoms Assessment (NSA-16)
Time frame: Baseline, Week 6
The Number of Participants With Treatment-Emergent Suicidal Ideation and Behavior Based on the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline up to Week 6
Percentage of Participants Who Discontinued (Rate of Discontinuation)
Time frame: Baseline through Week 6

Results and safety

Results posted to the registry on 14 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
10 mg LY2140023	21	9
80 mg LY2140023	21	17
160 mg LY2140023	20	11
Placebo	20	12

Primary outcome: Clinical Utility Index (CUI)

Time frame: Baseline through Week 6. Least squares mean (Standard Error). Unit: units on a scale

Measure	10 mg LY2140023 n = 21	80 mg LY2140023 n = 21	160 mg LY2140023 n = 20
Value	8.30 (0.54)	10.32 (0.52)	9.27 (0.55)

10 mg LY2140023 vs 80 mg LY2140023: LS Mean Differences: -2.02 (90% CI -3.37 to 0.00), Multiple Comparisons with The Best (MCB)
80 mg LY2140023 vs 160 mg LY2140023: LS Mean Differences: -1.05 (90% CI -2.42 to 0.32), Multiple Comparison with The Best (MCB)

Population analysed: All participants who received at least 1 dose of study drug and had CUI Total Score measurement at Week 6.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
10 mg LY2140023	1 of 21 (4.8%)	13 of 21 (61.9%)	Not reported
80 mg LY2140023	2 of 21 (9.5%)	13 of 21 (61.9%)	Not reported
160 mg LY2140023	0 of 20 (0%)	12 of 20 (60%)	Not reported
Placebo	2 of 20 (10%)	9 of 20 (45%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

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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 1-317-615-4459 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

22 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 LY2140023 in people with Schizophrenia, run by Denovo Biopharma LLC at 22 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 7 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: stopped early, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Japan, South Korea, Taiwan. 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?

Yes. Results are posted in the registry (first posted 14 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Clinical Utility Index (CUI) (time frame: Baseline through Week 6). 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 NCT01125358, 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 2021.