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| ID | Type | Description | Link |
|---|---|---|---|
| H8Y-MC-HBBM | Other Identifier | Eli Lilly and Company |
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An inpatient/outpatient study to see if LY2140023 is better than placebo in acutely ill patients with schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 160 mg LY2140023 | Experimental | 80 mg LY2140023 administered orally, twice daily (BID) for up to 7 weeks. |
|
| 4 mg Risperidone | Active Comparator | 2 mg risperidone administered orally, BID for up to 7 weeks. |
|
| Placebo | Placebo Comparator | Placebo administered orally, BID for up to 7 weeks. |
|
| 80 mg LY2140023 | Experimental | 40 mg LY2140023 administered orally, BID for up to 7 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risperidone | Drug | Administered orally. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in overall schizophrenia population | 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 | baseline, up to 7 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| A change from baseline in the Personal and Social Performance (PSP) score in the overall schizophrenia population | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Previously completed or withdrawn from this study, or any other study investigating LY2140023 or any predecessor molecules with glutamatergic activity.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.
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25890643 | Derived | 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. | |
| 25539791 | Derived |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 25, 2021 | |
| Reset | Sep 23, 2021 | |
| Release | Aug 11, 2022 |
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| Drug |
Administered orally. |
|
| LY2140023 | Drug | Administered orally. |
|
| baseline, up to 7 weeks of treatment |
| A change from baseline in the PANSS positive scale | baseline, up to 7 weeks of treatment |
| A change from baseline in the PANSS negative scale | baseline, up to 7 weeks of treatment |
| A change from baseline in PANSS General Psychopathology subscale | baseline, up to 7 weeks of treatment |
| A change from baseline in the Clinical Global Impression-Severity Scale (CGI-S) | baseline, up to 7 weeks of treatment |
| A change from baseline in the 16-item Negative Symptoms Assessment (NSA-16) | baseline, up to 7 weeks of treatment |
| A change from baseline in the Montgomery-Ǻsberg Depression Rating Scale (MADRS) | baseline, up to 7 weeks of treatment |
| PANSS total score | up to 7 weeks of treatment |
| A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in a female patients | baseline, up to 7 weeks of treatment |
| Rate of discontinuation | baseline, up to 7 weeks of treatment |
| Time to discontinuation | baseline, up to 7 weeks of treatment |
| A change from baseline on the EuroQol - 5 Dimensions (EQ-5D) Questionnaire | baseline, up to 7 weeks of treatment |
| A change from baseline on resource utilization, as measured by the Schizophrenia Resource Use Model (S-RUM) | 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) | baseline, up to 7 weeks of treatment |
| A change from baseline in Barnes Akathisia Scale (BAS) | baseline, up to 7 weeks of treatment |
| A change from baseline in Simpson-Angus Scale (SAS) | baseline, up to 7 weeks of treatment |
| A change from baseline in Abnormal Involuntary Movement Scale (AIMS) | baseline, up to 7 weeks of treatment |
| A mean change from baseline in Prolactin levels | baseline, up to 7 weeks of treatment |
| A change from baseline in weight | baseline, up to 7 weeks of treatment |
| Number of Treatment Emergent Adverse Events (TEAEs) | Up to 7 weeks of treatment |
| Change from baseline in electrocardiogram parameters | baseline, up to 7 weeks of treatment |
| A change from baseline in neurological examination | baseline, up to 7 weeks of treatment |
| Statistically different changes in vital signs from baseline | baseline, up to 7 weeks of treatment |
| Statistically different changes in lab values from baseline | baseline, up to 7 weeks of treatment |
| Population pharmacokinetics (PK) of LY2140023 | baseline, up to 7 weeks of treatment |
| A change from baseline in Columbia- Suicide Severity Rating Scale (C-SSRS) | baseline, up to 7 weeks of treatment |
| United States |
| 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 | United States |
| 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. | Paramount | California | 90723 | United States |
| 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 | United States |
| 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 | United States |
| 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. | Hollywood | Florida | 33021 | United States |
| 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 | United States |
| 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. | Chicago | Illinois | 60640 | United States |
| 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. | Hoffman Estates | Illinois | 60169 | United States |
| 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 | United States |
| 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 | United States |
| 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. | Flowood | Mississippi | 39232 | United States |
| 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. | Creve Coeur | Missouri | 63141 | United States |
| 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 | United States |
| 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 | United States |
| 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 | United States |
| 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 | United States |
| 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. | DeSoto | Texas | 75115 | United States |
| 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 | United States |
| 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 | Croatia |
| 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 | Russia |
| 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. | Lipetsk | 399007 | Russia |
| 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 | Russia |
| 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 | Russia |
| 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 | Russia |
| 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 | Russia |
| 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 | Russia |
| 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 | Russia |
| 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. |
| Reset | Sep 1, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 25, 2021 | Sep 23, 2021 | |||
| Aug 11, 2022 | Sep 1, 2022 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| C534551 | LY 2140023 |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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