Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

880

participants targeted

Target at P75+ for phase_2 schizophrenia

Timeline

Completed

Started Mar 2010

Typical duration for phase_2 schizophrenia

Geographic Reach

3 countries

28 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.2 years study duration

Study Start

First participant enrolled

March 1, 2010

Completed

11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2010

Completed

3 days until next milestone

First Posted

Study publicly available on registry

March 15, 2010

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed

Last Updated

September 25, 2012

Status Verified

May 1, 2012

Enrollment Period

2.2 years

First QC Date

March 12, 2010

Last Update Submit

September 18, 2012

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

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

Secondary Outcomes (27)

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
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
+22 more secondary outcomes

Study Arms (4)

160 mg LY2140023

EXPERIMENTAL

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

Drug: LY2140023

4 mg Risperidone

ACTIVE COMPARATOR

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

Drug: Risperidone

Placebo

PLACEBO COMPARATOR

Placebo administered orally, BID for up to 7 weeks.

Drug: Placebo

80 mg LY2140023

EXPERIMENTAL

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

Drug: LY2140023

Interventions

RisperidoneDRUG

Administered orally.

4 mg Risperidone

PlaceboDRUG

Administered orally.

Placebo

LY2140023DRUG

Administered orally.

160 mg LY214002380 mg LY2140023

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.
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

You may not qualify if:

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.
+5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (28)

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, United States

Location

Garden Grove, California, 92845, United States

Location

Paramount, California, 90723, United States

Location

Washington D.C., District of Columbia, 20016, United States

Location

Fort Lauderdale, Florida, 33308, United States

Location

Hollywood, Florida, 33021, United States

Location

Atlanta, Georgia, 30308, United States

Location

Chicago, Illinois, 60640, United States

Location

Hoffman Estates, Illinois, 60169, United States

Location

Lake Charles, Louisiana, 70629, United States

Location

Shreveport, Louisiana, 71104, United States

Location

Flowood, Mississippi, 39232, United States

Location

Creve Coeur, Missouri, 63141, United States

Location

Cedarhurst, New York, 11516, United States

Location

Rochester, New York, 14615, United States

Location

Philadelphia, Pennsylvania, 19131, United States

Location

Austin, Texas, 78754, United States

Location

DeSoto, Texas, 75115, United States

Location

Houston, Texas, 77008, United States

Location

Zagreb, 10090, Croatia

Location

Khot'kovo, 127025, Russia

Location

Lipetsk, 399007, Russia

Location

Moscow, 115522, Russia

Location

Nizhny Novgorod, 603155, Russia

Location

Saint Petersburg, 190121, Russia

Location

Samara, 443016, Russia

Location

Saratov, 410028, Russia

Location

Yaroslavl, 150003, Russia

Location

Related Publications (2)

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.
PMID: 25890643DERIVED
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.
PMID: 25539791DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

RisperidoneLY 2140023

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

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

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 12, 2010

First Posted

March 15, 2010

Study Start

March 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

September 25, 2012

Record last verified: 2012-05

Locations

CR(1)RU(8)US(19)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (27)

Study Arms (4)

160 mg LY2140023

4 mg Risperidone

Placebo

80 mg LY2140023

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (28)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations