A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00845026
First received: February 13, 2009
Last updated: February 25, 2011
Last verified: February 2011
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Purpose
This study will assess time to discontinuation due to lack of tolerability among patients with schizophrenia receiving LY2140023, given orally twice daily for 24 weeks, versus those on atypical antipsychotic standard-of-care treatment. Lack of tolerability is defined as discontinuation due to adverse events (AEs). Patients who complete the active treatment phase will be eligible to continue to an optional 28 weeks of treatment extension phase. This extension phase will assess key safety and efficacy measures.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: LY2140023 Drug: aripiprazole Drug: olanzapine Drug: risperidone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Long-Term, Phase 2, Multicenter, Randomized, Open-Label Comparative Safety Study of LY2140023 Versus Atypical Antipsychotic Standard of Care 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:
- Time to discontinuation due to AE from baseline to 24 weeks endpoint [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Incidence of epileptiform activity in Electroencephalograms (EEGs) to 52 week endpoint [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]
- Incidence of potentially clinically significant changes in QT intervals Electrocardiograms (ECGs) to 52 weeks endpoint [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]
- Incidence of change in Neurological Examination to 52 weeks endpoint [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]
- Change from baseline in blood pressure to 52 weeks endpoint [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]
- Changes from baseline in weight to 52 weeks endpoint [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]
- Incidence of potentially clinical significant change in laboratory values to 52 weeks endpoint [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]
- Incidence of potentially clinical significant change of Columbia-Suicide Severity Rating Scale (C-SSRS) to 52 weeks endpoint [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]
- Change from baseline in Positive and Negative Syndrome Scale (PANSS) to 52 weeks endpoint [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Clinical Global Impression Severity Scale (CGI-S) to 52 weeks endpoint [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]
- Change from baseline in 16-item Negative Symptoms Assessment (NSA-16) to 52 weeks endpoint [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB) to 52 weeks endpoint [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) to 52 weeks endpoint [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
- Change from baseline in UCSD Performance-Based Skills Assessment-B (UPSA-B) to 52 weeks endpoint [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
- Rate of response: The number of patients with reduction 30% or more from baseline to 6 weeks and baseline to 24 weeks endpoint on PANSS Total Score [ Time Frame: Baseline, 6 weeks, 24 weeks ] [ Designated as safety issue: No ]
- Rate of remission: The number of patients with endpoint score of mild or better of 8 specific PANSS items [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
- Rate of relapse:The number of patients with a specified increase in at least one (PANSS) positive item score, or, psychiatric hospitalization, or suicidal ideation or behavior [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) to 52 weeks endpoint [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Personal and Social Performance(PSP) to 52 weeks endpoint [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
- Change from baseline in EuroQoL Questionnaire-5 Dimension(EQ-5D) to 52 weeks endpoint [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Resource utilization score to 24 weeks endpoint [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Barnes Akathisia Scale (BAS) to 52 weeks endpoint [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]
- Change from baseline in Simpson-Angus Scale(SAS) to 52 weeks endpoint [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]
- Change from baseline in Abnormal Involuntary Movement Scale (AIMS) to 52 weeks endpoint [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]
- Change from baseline in pulse rate to 52 weeks endpoint [ Time Frame: Baseline, 52 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 261 |
| Study Start Date: | March 2009 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: LY2140023 |
Drug: LY2140023
80mg, oral tablets,twice daily: 40 mg in the morning, 40 mg in the evening, for 24 weeks. The dose may be adjusted to a minimum of 40mg or a maximum of 160mg.
|
| Active Comparator: aripiprazole |
Drug: aripiprazole
10mg, oral tablets, once a day in the evening for three days. Followed by a dose increase to 20mg, 2-10mg oral tablets,once a day in the evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10mg or a maximum of 30mg (3-10mg oral tablets).
|
| Active Comparator: olanzapine |
Drug: olanzapine
10mg dose (2-5mg oral tablets) once every evening, for 3 days. Followed by an increase to 15mg (3-5mg oral tablets) once every evening, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 10mg or a maximum of 20mg (4-5mg oral tablets).
Other Names:
|
| Active Comparator: risperidone |
Drug: risperidone
2mg dose, 2-1mg oral tablets, given once or twice a day for 3 days. Followed by an increase to 4mg (4-1mg tablets), given once or twice a day, for 23 weeks and 4 days. The dose may be adjusted to a minimum of 2mg/day or a maximum of 6mg/day (6-1mg tablets).
|
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, in the investigator's opinion, must require a switch to another antipsychotic medication as clinically indicated or initiation of an antipsychotic agent
- Patients must be willing and able to be hospitalized, or to remain hospitalized (if already hospitalized), for up to 17 days
- The investigator expects, at the time of enrollment, that the patient will be able to be discharged from the hospital after the first 2 weeks of active treatment
- Disease symptoms must meet a certain range as assessed by the clinician
- Patients must have evidence of functional impairment (i.e. social or vocational deficiency)
- 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, seizures, uncontrolled diabetes, certain diseases of the liver, 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: NCT00845026
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. | |
| Escondido, California, United States, 92025 | |
| 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, 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. | |
| Washington, District of Columbia, United States, 20016 | |
| 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, 60194 | |
| 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. | |
| Indianapolis, Indiana, United States, 46222 | |
| 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. | |
| Lake Charles, Louisiana, United States, 70601 | |
| United States, New Jersey | |
| 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. | |
| Willingboro, New Jersey, United States, 08046 | |
| 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. | |
| Amityville, New York, United States, 11701 | |
| United States, Oklahoma | |
| 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. | |
| Oklahoma City, Oklahoma, United States, 73103 | |
| 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. | |
| Desoto, Texas, United States, 75115 | |
| Germany | |
| 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. | |
| Jena, Germany, D-07740 | |
| 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. | |
| Mannheim, Germany, 68159 | |
| 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. | |
| Wiesbaden, Germany, D-65199 | |
| 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. | |
| Mexico City, Mexico, 14420 | |
| 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, 64290 | |
| 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. | |
| Khotkovo, Russian Federation, 127025 | |
| 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, 123367 | |
| 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. | |
| Nizhniy Novgorod, Russian Federation, 603155 | |
| 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, 192019 | |
| 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. | |
| Samara, Russian Federation, 443016 | |
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: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00845026 History of Changes |
| Other Study ID Numbers: | 12648, H8Y-MC-HBBR |
| Study First Received: | February 13, 2009 |
| Last Updated: | February 25, 2011 |
| Health Authority: | United States: Food and Drug Administration Russia: Ethics Committee Mexico: Ministry of Health |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Antipsychotic Agents Risperidone Olanzapine Aripiprazole Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Psychotropic Drugs Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Dopamine Antagonists Dopamine Agents Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 23, 2013