A Study in Schizophrenic Patients
This study has been terminated.
(The decision to stop the trial was based on efficacy results in the overall schizophrenia participant population.)
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01125358
First received: May 17, 2010
Last updated: January 11, 2013
Last verified: November 2012
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Purpose
This study is designed to compare 3 doses of LY2140023 for the treatment of schizophrenia as assessed at endpoint (up to 7 weeks) using the Clinical Utility Index (CUI), a measure of efficacy, safety, and tolerability.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: LY2140023 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Double-Blind, Placebo-Controlled Study of 3 Doses of LY2140023 in Patients With DSM-IV-TR Schizophrenia |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Clinical Utility Index (CUI) [ Time Frame: up to 7 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change from baseline up to 7 week endpoint in the Positive and Negative Syndrome Scale (PANSS) total score, positive score, negative score, and psychopathology subscale [ Time Frame: Baseline, up to 7 weeks ] [ Designated as safety issue: No ]
- Change from baseline up to 7 week endpoint in the Clinical Global Impression-Severity Scale (CGI-S) [ Time Frame: Baseline, up to 7weeks ] [ Designated as safety issue: No ]
- Change from baseline up to 7 week endpoint in the 16-item Negative Symptoms Assessment (NSA-16) [ Time Frame: Baseline, up to 7weeks ] [ Designated as safety issue: No ]
- The number of patients with statistically significant changes (treatment emergent ideation and behavior; improvement) based on the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline, up to 9 weeks ] [ Designated as safety issue: Yes ]
- Rate of discontinuation [ Time Frame: Through 7 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | May 2010 |
| Study Completion Date: | September 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 10 mg LY2140023 |
Drug: LY2140023
Administered orally, twice daily for up to 7 weeks of treatment
|
| Experimental: 80 mg LY2140023 |
Drug: LY2140023
Administered orally, twice daily for up to 7 weeks of treatment
|
| Experimental: 160 mg LY2140023 |
Drug: LY2140023
Administered orally, twice daily for up to 7 weeks of treatment
|
| Placebo Comparator: Placebo |
Drug: Placebo
Administered orally, twice daily for up to 7 weeks of treatment
|
Eligibility| Ages Eligible for Study: | 20 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; 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
- 1 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 based on the investigator's clinical judgment. 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 4 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
Exclusion Criteria:
- 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
- Have any known history of receiving treatment with clozapine at any dose, as determined at baseline
- Have received treatment with a depot formulation of an antipsychotic medication within the 6 months prior entering the study
- 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, untreated 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 central nervous system (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
- Electroconvulsive therapy (ECT) within 3 months of entering the study or who will have ECT at any time during the study
- Leukopenia
- Medical history of Human Immunodeficiency Virus positive (HIV+) status
- Higher than normal blood prolactin levels
- Certain electrocardiogram results
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01125358
Locations
| Japan | |
| 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. | |
| Aichi, Japan, 470-1168 | |
| 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. | |
| Kanagawa, Japan, 216-0003 | |
| 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. | |
| Kumamoto, Japan, 861-0002 | |
| 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. | |
| Kyoto, Japan, 625-8502 | |
| 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. | |
| Nagano, Japan, 384-8540 | |
| 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. | |
| Nagasaki, Japan, 856-0847 | |
| 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. | |
| Nara, Japan, 634-8522 | |
| 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. | |
| Osaka, Japan, 569-1041 | |
| 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. | |
| Saga, Japan, 842-0192 | |
| 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. | |
| Tokyo, Japan, 114-0024 | |
| 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. | |
| Toyama, Japan, 939-8073 | |
| 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. | |
| Yamaguchi, Japan, 759-6321 | |
| Korea, Republic of | |
| 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. | |
| Goyang-Si, Korea, Republic of, 410-719 | |
| 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. | |
| Incheon, Korea, Republic of, 400-711 | |
| 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. | |
| Naju, Korea, Republic of, 520-833 | |
| 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. | |
| Seoul, Korea, Republic of, 150-713 | |
| 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. | |
| Suwon-City, Korea, Republic of, 442-723 | |
| 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. | |
| Yongin, Korea, Republic of, 446-769 | |
| Taiwan | |
| 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. | |
| Changhua, Taiwan, 50550 | |
| 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. | |
| Kao Hsiung, Taiwan, 802 | |
| 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. | |
| Neihu Taipei, Taiwan, 114 | |
| 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. | |
| Taipei, Taiwan, 110 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4459 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: | NCT01125358 History of Changes |
| Other Study ID Numbers: | 13560, H8Y-JE-HBDC |
| Study First Received: | May 17, 2010 |
| Last Updated: | January 11, 2013 |
| Health Authority: | United States: Food and Drug Administration Japan: Ministry of Health, Labor and Welfare Korea: Food and Drug Administration Taiwan : Food and Drug Administration |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders |
ClinicalTrials.gov processed this record on June 17, 2013