A Study of LY2140023 in Schizophrenia Patients With Prominent Negative Symptoms - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by (Responsible Party):	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01052103

Purpose

The purpose of this study is to determine whether LY2140023, when added to standard-of-care antipsychotic treatment, will improve negative symptoms.

Condition	Intervention	Phase
Schizophrenia	Drug: LY2140023 Drug: Placebo Drug: Standard of Care	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A 17-Week, Phase 2, Multicenter, Randomized, Double-Blind Study of Treatment With LY2140023 Combined With Standard of Care Compared to Placebo Combined With Standard of Care in the Treatment of Patients With Prominent Negative Symptoms of Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Olanzapine LY2140023

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Change from baseline in the 16-item Negative Symptoms Assessment (NSA-16) [ Time Frame: Baseline, 16 or 17 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline, 16 or 17 weeks ] [ Designated as safety issue: No ]
Change from baseline in Clinical Global Impression Severity Scale (CGI-S) [ Time Frame: Baseline, 16 or 17 weeks ] [ Designated as safety issue: No ]
Change from baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB) [ Time Frame: Baseline, 17 weeks ] [ Designated as safety issue: No ]
Change from baseline in University of California at San Diego Performance-Based Skills Assessment-Brief Version (UPSA-B) [ Time Frame: Baseline, 17 weeks ] [ Designated as safety issue: No ]
Change from baseline in Barnes-Akathisia Scale [ Time Frame: Baseline, 16 or 17 weeks ] [ Designated as safety issue: Yes ]
Incidence of epileptiform activity in Electroencephalograms (EEGs) [ Time Frame: Up to 19 weeks ] [ Designated as safety issue: Yes ]
Incidence of potentially clinically significant changes in QT intervals Electrocardiograms (ECGs) [ Time Frame: Up to 17 weeks ] [ Designated as safety issue: Yes ]
Incidence of change in Neurological Examination [ Time Frame: Up to 17 weeks ] [ Designated as safety issue: Yes ]
Change from baseline in blood pressure [ Time Frame: Baseline, 16 or 17 weeks ] [ Designated as safety issue: Yes ]
Change from baseline in weight [ Time Frame: Baseline, 16 or 17 weeks ] [ Designated as safety issue: Yes ]
Incidence of potentially clinical significant change in laboratory values [ Time Frame: Up to 17 weeks ] [ Designated as safety issue: Yes ]
Incidence of potentially clinical significant change of Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to 17 weeks ] [ Designated as safety issue: Yes ]
Change from baseline to 17 weeks endpoint in Personal and Social Performance (PSP) Scale [ Time Frame: Baseline, 17 weeks ] [ Designated as safety issue: No ]
Time to discontinuation [ Time Frame: Up to 17 weeks ] [ Designated as safety issue: No ]
Change from baseline in Simpson Angus Scale [ Time Frame: Baseline, 16 or 17 weeks ] [ Designated as safety issue: Yes ]
Change from baseline in Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline, 16 or 17 weeks ] [ Designated as safety issue: Yes ]
Change from baseline in pulse rate [ Time Frame: Baseline, 16 or 17 weeks ] [ Designated as safety issue: Yes ]
Change from 1 week to 18 weeks endpoint in the Schizophrenia Resource Use Module (S-RUM) [ Time Frame: 1 week, 18 weeks ] [ Designated as safety issue: No ]
Change from baseline to 17 weeks endpoint in the EuroQol Questionnaire-5 Dimension (EQ-5D) [ Time Frame: baseline, 17 weeks ] [ Designated as safety issue: No ]
Change from baseline to 17 weeks endpoint in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) [ Time Frame: baseline, 17 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	280
Study Start Date:	January 2010
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: LY2140023	Drug: LY2140023 40mg, oral tablets, twice daily: 20 mg in the morning, 20 mg in the evening, for 16 or 17 weeks. The dose may be adjusted to a minimum of 20mg or a maximum of 80mg. Drug: Standard of Care U.S. label prescribed dose of one of the following Standard of Care Antipsychotics (aripiprazole, olanzapine, risperidone, quetiapine) Other Names: Zyprexa LY170053
Placebo Comparator: Placebo	Drug: Placebo Placebo oral tablets, twice daily: in the morning and in the evening, for 16 or 17 weeks. Drug: Standard of Care U.S. label prescribed dose of one of the following Standard of Care Antipsychotics (aripiprazole, olanzapine, risperidone, quetiapine) Other Names: Zyprexa LY170053

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of schizophrenia
Patients must have been receiving monotherapy treatment for at least 3 months prior to study entry with one of 4 atypical antipsychotic medications (aripiprazole, olanzapine, risperidone, quetiapine)
Disease symptoms must meet a certain range as assessed by the clinician
Patients must have evidence of prominent negative symptoms of schizophrenia (i.e. blunted affect, emotional withdrawal, or motor retardation)
Patients must be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures
Patients must be able to understand the nature of the study and have given their informed consent

Exclusion Criteria:

Patients who are actively suicidal
Patients who are pregnant or nursing
Patients who have had electroconvulsive therapy (ECT) within 3 months of screening or who will have ECT at any time during the study
Patients with uncorrected narrow-angle glaucoma, history of or current seizure disorder, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, uncontrolled thyroid condition or other serious or unstable illnesses
Patients with Parkinson's disease, psychosis related to dementia or related disorders
Patients with known Human Immunodeficiency Virus positive (HIV+) status

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052103

Contacts

Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

Locations

United States, California
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.	Recruiting
Garden Grove, California, United States, 92845
Contact: Eli Lilly
United States, District of Columbia
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.	Recruiting
Washington, District of Columbia, United States, 20016
Contact: Eli Lilly
United States, Illinois
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.	Recruiting
Chicago, Illinois, United States, 60640
Contact: Eli Lilly
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.	Recruiting
Hoffman Estates, Illinois, United States, 60169
Contact: Eli Lilly
United States, Indiana
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.	Recruiting
Indianapolis, Indiana, United States, 46222
Contact: Eli Lilly
United States, Louisiana
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.	Recruiting
Lake Charles, Louisiana, United States, 70629
Contact: Eli Lilly
United States, New York
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.	Recruiting
Cedarhurst, New York, United States, 11516
Contact: Eli Lilly
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.	Recruiting
New York, New York, United States, 10035
Contact: Eli Lilly
United States, Texas
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.	Recruiting
Austin, Texas, United States, 78731
Contact: Eli Lilly
Israel
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.	Recruiting
Ashkelon, Israel, 78306
Contact: Eli Lilly
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.	Recruiting
Jerusalem, Israel, 91351
Contact: Eli Lilly
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.	Recruiting
Tel Hashomer, Israel, 52661
Contact: Eli Lilly
Italy
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.	Recruiting
Parma, Italy, 43100
Contact: Eli Lilly
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.	Recruiting
Torino, Italy, 10126
Contact: Eli Lilly
Spain
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.	Recruiting
Barcelona, Spain, 08036
Contact: Eli Lilly
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.	Recruiting
Zamora, Spain, 49021
Contact: Eli Lilly

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:	NCT01052103 History of Changes
Other Study ID Numbers:	13261, H8Y-MC-HBCO
Study First Received:	January 13, 2010
Last Updated:	January 20, 2012
Health Authority:	United States: Food and Drug Administration; Israel: Ministry of Health; Italy: Ministry of Health; Spain: Ministry of Health

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012