A Study of LY2140023 in Schizophrenia Patients With Prominent Negative Symptoms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01052103
First received: January 13, 2010
Last updated: September 18, 2012
Last verified: July 2012
  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 2

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:


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
Study Completion Date: June 2012
Primary Completion Date: June 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
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: NCT01052103

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.
Garden Grove, California, United States, 92845
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.
Chicago, Illinois, United States, 60640
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.
Hoffman Estates, Illinois, United States, 60169
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.
New York, New York, United States, 10035
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.
Jerusalem, Israel, 91060
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.
Parma, Italy, 43100
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.
Torino, Italy, 10126
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.
Barcelona, Spain, 08036
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.
Zamora, Spain, 49021
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: September 18, 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 October 02, 2014