A Study of LY2140023 in Patients With Schizophrenia
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether at least 1 dose level of LY2140023 given to acutely ill patients with schizophrenia will demonstrate significantly greater efficacy as compared to placebo.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 80 mg LY2140023 40 mg LY2140023 administered orally, twice daily (BID) for up to 7 weeks of treatment. |
Drug: LY2140023
Administered orally
|
| Experimental: 40 mg LY2140023 20 mg LY2140023 administered orally, BID for up to 7 weeks of treatment. |
Drug: LY2140023
Administered orally
|
| Experimental: 10 mg LY2140023 5 mg LY2140023 administered orally, BID for up to 7 weeks of treatment. |
Drug: LY2140023
Administered orally
|
| Placebo Comparator: Placebo Administered orally, BID for up to 7 weeks of treatment. |
Drug: Placebo
Administered orally
|
Outcome Measures
Primary Outcome Measures
- Change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score [Baseline, Up to 7 weeks]
Secondary Outcome Measures
- Change from baseline in the PANSS total score in a predefined genetic subpopulation of schizophrenia patients [Baseline, Up to 7 weeks]
- Change from baseline in the Personal and Social Performance (PSP) score in a predefined subpopulation [Baseline, Up to 7 weeks]
- Change from baseline in the PSP score [Baseline, Up to 7 weeks]
- Proportion of participants who are responders [Baseline up to 7 weeks]
- Time to response [Baseline up to 7 weeks]
- Change from baseline in the Clinical Global Impression-Severity (CGI-S) Scale [Baseline, Up to 7 weeks]
- Change from baseline in the 16-item Negative Symptoms Assessment (NSA-16) [Baseline, Up to 7 weeks]
- Change from baseline on EuroQOL - 5 dimension (EQ-5D) Questionnaire [Baseline, Up to 7 weeks]
- Change from baseline on Schizophrenia Resource Utilization Model (S-RUM) [Baseline, Up to 7 weeks]
- Change from baseline on Subjective Well-Being Under Neuroleptic Treatment Scale - Short Form (SWN-S) [Baseline, Up to 7 weeks]
- Change from baseline in Barnes Akathisia Scale (BAS) [Baseline, Up to 7 weeks]
- Change from baseline in Simpson-Angus Scale (SAS) [Baseline, Up to 7 weeks]
- Change from baseline in Abnormal Involuntary Movement Scales (AIMS) [Baseline, Up to 7 weeks]
- Number of participants with suicidal behaviors and ideations measured by the Columbia-Suicide Severity Rating Scale (CSSRS) [Baseline up to 7 weeks]
- Rate of discontinuation [Baseline up to 7 weeks]
- Time to discontinuation [Baseline up to 7 weeks]
- Change from baseline in the PANSS subscores [Baseline, Up to 7 weeks]
- Change from baseline in Prolactin [Baseline, Up to 7 weeks]
- Change from baseline in weight [Baseline, Up to 7 weeks]
- Change from baseline in the PANSS total score in females [Baseline, Up to 7 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision DSM-IV-TR; and confirmed by the Structured Clinical Interview for DSM-IV-TR (SCID)
-
Non pregnant female patients who agree to use acceptable birth control
-
Participants must be considered moderately ill in the opinion of the investigator
-
Patients in whom a modification of antipsychotic medication or initiation of antipsychotic medication is acutely indicated in the opinion of the investigator
-
Willing to participate in a minimum of 2 weeks of inpatient hospitalization.
-
One 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
-
Patients must be considered reliable and have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures
Exclusion Criteria:
-
Patients who have a history of inadequate clinical response to antipsychotic treatment for schizophrenia
-
Diagnosis of substance dependence or substance abuse within 6 month of study entry
-
Diagnosis of substance-induced psychosis within 7 days of study entry
-
Currently enrolled in, or discontinued within 6 months from a clinical trial involving an investigational product or unapproved use of a drug or device
-
Participated in any clinical trial with any pharmacological treatment intervention for which they received a study-related medication in the 6 months prior to study entry
-
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 study entry
-
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
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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
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Electroconvulsive therapy (ECT) within 3 months of entering the study or who will have ECT at any time during the study
-
History of low white blood cell count
-
Medical history of Human Immunodeficiency Virus positive (HIV+) status.
-
Higher than normal blood prolactin levels
-
Abnormal electrocardiogram results
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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. | Wichita | Kansas | United States | 67207 |
| 2 | 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. | Guadalajara | Mexico | 44340 | |
| 3 | 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. | Monterrey | Mexico | 64060 | |
| 4 | 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. | San Juan | Puerto Rico | 00926 | |
| 5 | 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 | Russian Federation | 399007 | |
| 6 | 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 | Russian Federation | 109559 | |
| 7 | 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 | Russian Federation | 190005 | |
| 8 | 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 | Russian Federation | 410060 | |
| 9 | 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. | Voronezh | Russian Federation | 394071 | |
| 10 | 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. | Donetsk | Ukraine | 83037 | |
| 11 | 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. | Kiev | Ukraine | 2660 | |
| 12 | 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. | Lviv | Ukraine | 79021 | |
| 13 | 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. | Vinnytsya | Ukraine | 21005 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- 12430
- H8Y-MC-HBBN