A Study of LY2140023 in Schizophrenia Patients With Prominent Negative Symptoms
This study has been completed.
Sponsor:
Eli Lilly and Company
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
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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:
|
| 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:
|
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
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 June 17, 2013