A Study of LY2140023 in Patients With Schizophrenia

This study has been terminated.
(The decision to stop the trial was based on efficacy results in the overall schizophrenia participant population.)
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01307800
First received: March 1, 2011
Last updated: January 11, 2013
Last verified: October 2012
  Purpose

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 Intervention Phase
Schizophrenia
Drug: LY2140023
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study of 3 Doses of LY2140023 Monohydrate in the Acute Treatment of Patients With DSM‑IV‑TR Schizophrenia

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in the PANSS total score in a predefined genetic subpopulation of schizophrenia patients [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the Personal and Social Performance (PSP) score in a predefined subpopulation [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the PSP score [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: No ]
  • Proportion of participants who are responders [ Time Frame: Baseline up to 7 weeks ] [ Designated as safety issue: No ]
  • Time to response [ Time Frame: Baseline up to 7 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the Clinical Global Impression-Severity (CGI-S) Scale [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the 16-item Negative Symptoms Assessment (NSA-16) [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: No ]
  • Change from baseline on EuroQOL - 5 dimension (EQ-5D) Questionnaire [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: No ]
  • Change from baseline on Schizophrenia Resource Utilization Model (S-RUM) [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: No ]
  • Change from baseline on Subjective Well-Being Under Neuroleptic Treatment Scale - Short Form (SWN-S) [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Barnes Akathisia Scale (BAS) [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in Simpson-Angus Scale (SAS) [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in Abnormal Involuntary Movement Scales (AIMS) [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants with suicidal behaviors and ideations measured by the Columbia-Suicide Severity Rating Scale (CSSRS) [ Time Frame: Baseline up to 7 weeks ] [ Designated as safety issue: Yes ]
  • Rate of discontinuation [ Time Frame: Baseline up to 7 weeks ] [ Designated as safety issue: No ]
  • Time to discontinuation [ Time Frame: Baseline up to 7 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in the PANSS subscores [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Prolactin [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in weight [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in the PANSS total score in females [ Time Frame: Baseline, Up to 7 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1100
Study Start Date: March 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01307800

Locations
United States, Kansas
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
Mexico
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
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
Puerto Rico
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
Russian Federation
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
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
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
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
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
Ukraine
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
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
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
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01307800     History of Changes
Other Study ID Numbers: 12430, H8Y-MC-HBBN
Study First Received: March 1, 2011
Last Updated: January 11, 2013
Health Authority: United States: Food and Drug Administration
Croatia: Ministry of Health and Social Care
Russia: Ministry of Health of the Russian Federation
Romania: National Medicines Agency

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 20, 2014