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A Study in Schizophrenia Patients

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Risperidone
Placebo
LY2140023
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 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

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:

    • head trauma, stroke, or 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

Sites / Locations

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Experimental

Arm Label

160 mg LY2140023

4 mg Risperidone

Placebo

80 mg LY2140023

Arm Description

80 mg LY2140023 administered orally, twice daily (BID) for up to 7 weeks.

2 mg risperidone administered orally, BID for up to 7 weeks.

Placebo administered orally, BID for up to 7 weeks.

40 mg LY2140023 administered orally, BID for up to 7 weeks.

Outcomes

Primary Outcome Measures

A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in overall schizophrenia population
A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in a genetic subgroup of schizophrenia patients

Secondary Outcome Measures

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

Full Information

First Posted
March 12, 2010
Last Updated
September 18, 2012
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT01086748
Brief Title
A Study in Schizophrenia Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
880 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
160 mg LY2140023
Arm Type
Experimental
Arm Description
80 mg LY2140023 administered orally, twice daily (BID) for up to 7 weeks.
Arm Title
4 mg Risperidone
Arm Type
Active Comparator
Arm Description
2 mg risperidone administered orally, BID for up to 7 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered orally, BID for up to 7 weeks.
Arm Title
80 mg LY2140023
Arm Type
Experimental
Arm Description
40 mg LY2140023 administered orally, BID for up to 7 weeks.
Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Description
Administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally.
Intervention Type
Drug
Intervention Name(s)
LY2140023
Intervention Description
Administered orally.
Primary Outcome Measure Information:
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
A change from baseline in the PANSS positive scale
Time Frame
baseline, up to 7 weeks of treatment
Title
A change from baseline in the PANSS negative scale
Time Frame
baseline, up to 7 weeks of treatment
Title
A change from baseline in PANSS General Psychopathology subscale
Time Frame
baseline, up to 7 weeks of treatment
Title
A change from baseline in the Clinical Global Impression-Severity Scale (CGI-S)
Time Frame
baseline, up to 7 weeks of treatment
Title
A change from baseline in the 16-item Negative Symptoms Assessment (NSA-16)
Time Frame
baseline, up to 7 weeks of treatment
Title
A change from baseline in the Montgomery-Ǻsberg Depression Rating Scale (MADRS)
Time Frame
baseline, up to 7 weeks of treatment
Title
PANSS total score
Time Frame
up to 7 weeks of treatment
Title
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
Title
Rate of discontinuation
Time Frame
baseline, up to 7 weeks of treatment
Title
Time to discontinuation
Time Frame
baseline, up to 7 weeks of treatment
Title
A change from baseline on the EuroQol - 5 Dimensions (EQ-5D) Questionnaire
Time Frame
baseline, up to 7 weeks of treatment
Title
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
Title
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
Title
A change from baseline in Barnes Akathisia Scale (BAS)
Time Frame
baseline, up to 7 weeks of treatment
Title
A change from baseline in Simpson-Angus Scale (SAS)
Time Frame
baseline, up to 7 weeks of treatment
Title
A change from baseline in Abnormal Involuntary Movement Scale (AIMS)
Time Frame
baseline, up to 7 weeks of treatment
Title
A mean change from baseline in Prolactin levels
Time Frame
baseline, up to 7 weeks of treatment
Title
A change from baseline in weight
Time Frame
baseline, up to 7 weeks of treatment
Title
Number of Treatment Emergent Adverse Events (TEAEs)
Time Frame
Up to 7 weeks of treatment
Title
Change from baseline in electrocardiogram parameters
Time Frame
baseline, up to 7 weeks of treatment
Title
A change from baseline in neurological examination
Time Frame
baseline, up to 7 weeks of treatment
Title
Statistically different changes in vital signs from baseline
Time Frame
baseline, up to 7 weeks of treatment
Title
Statistically different changes in lab values from baseline
Time Frame
baseline, up to 7 weeks of treatment
Title
Population pharmacokinetics (PK) of LY2140023
Time Frame
baseline, up to 7 weeks of treatment
Title
A change from baseline in Columbia- Suicide Severity Rating Scale (C-SSRS)
Time Frame
baseline, up to 7 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 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: head trauma, stroke, or 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
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.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
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.
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
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.
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
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.
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
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.
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
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.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
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.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
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.
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
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.
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Facility Name
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.
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104
Country
United States
Facility Name
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.
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
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.
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
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.
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
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.
City
Rochester
State/Province
New York
ZIP/Postal Code
14615
Country
United States
Facility Name
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.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19131
Country
United States
Facility Name
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.
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
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.
City
Desoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
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.
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
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.
City
Zagreb
ZIP/Postal Code
10090
Country
Croatia
Facility Name
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.
City
Khotkovo
ZIP/Postal Code
127025
Country
Russian Federation
Facility Name
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City
Lipetsk
ZIP/Postal Code
399007
Country
Russian Federation
Facility Name
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.
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
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.
City
Nizhniy Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Facility Name
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.
City
Saint Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
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.
City
Samara
ZIP/Postal Code
443016
Country
Russian Federation
Facility Name
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.
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
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.
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
25890643
Citation
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.
Results Reference
derived
PubMed Identifier
25539791
Citation
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.
Results Reference
derived

Learn more about this trial

A Study in Schizophrenia Patients

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