A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00845026

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:

MedlinePlus related topics: Schizophrenia Suicide

Drug Information available for: Risperidone Aripiprazole Olanzapine

U.S. FDA Resources

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: Zyprexa LY170053
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
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Washington, District of Columbia, United States, 20016
United States, Illinois
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Chicago, Illinois, United States, 60640
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Hoffman Estates, Illinois, United States, 60194
United States, Indiana
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Indianapolis, Indiana, United States, 46222
United States, Louisiana
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Lake Charles, Louisiana, United States, 70601
United States, New Jersey
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Willingboro, New Jersey, United States, 08046
United States, New York
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Amityville, New York, United States, 11701
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
United States, Texas
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Desoto, Texas, United States, 75115
Germany
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Jena, Germany, D-07740
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Mannheim, Germany, 68159
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Wiesbaden, Germany, D-65199
Mexico
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Guadalajara, Mexico, 44340
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Mexico City, Mexico, 14420
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Monterrey, Mexico, 64290
Russian Federation
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Khotkovo, Russian Federation, 127025
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Lipetsk, Russian Federation, 399007
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Moscow, Russian Federation, 123367
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Nizhniy Novgorod, Russian Federation, 603155
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Saint Petersburg, Russian Federation, 192019
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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, 2012