A Comparison Study of LY2140023 and Aripiprazole in Schizophrenia Patients - Full Text View

Purpose

The purpose of this study is to determine whether weight gain will be significantly less in LY2140023 than aripiprazole in patients with schizophrenia.

Condition	Intervention	Phase
Schizophrenia	Drug: LY2140023 Drug: Aripiprazole	Phase 3

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 Phase 3, Multicenter, Double-Blind Comparison of LY2140023 and Aripiprazole in Patients With DSM-IV-TR Schizophrenia Followed by Open-Label Treatment With LY2140023

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Aripiprazole

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Change from baseline to 24 weeks in body weight [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Proportion of participants with clinically significant weight change [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: Yes ]
Change from baseline up to 24 weeks in Barnes Akathisia Scale (BAS) [ Time Frame: Baseline, up to 24 weeks ] [ Designated as safety issue: Yes ]
Change from baseline up to 24 weeks in Simpson-Angus Scale (SAS) [ Time Frame: Baseline, up to 24 weeks ] [ Designated as safety issue: Yes ]
Change from baseline up to 24 weeks in Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline, up to 24 weeks ] [ Designated as safety issue: Yes ]
Change from baseline up to 24 weeks in Positive and Negative Syndrome Scale (PANSS) total and subscale scores [ Time Frame: Baseline, up to 24 weeks ] [ Designated as safety issue: No ]
Change from baseline up to 24 weeks in EuroQol-5 Dimensions Questionnaire (EQ-5D) [ Time Frame: Baseline, up to 24 weeks ] [ Designated as safety issue: No ]
Schizophrenia Resource Utilization Module (S-RUM) [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: No ]
Change from baseline up to 24 weeks in Subjective Well-Being Under Neuroleptic Treatment Scale- Short Form (SWN-S) total score and domain scores [ Time Frame: Baseline, up to 24 weeks ] [ Designated as safety issue: No ]
Change from baseline up to 24 weeks in Personal and Social Performance (PSP) Score [ Time Frame: Baseline, up to 24 weeks ] [ Designated as safety issue: No ]
Change from baseline up to 24 weeks in Clinical Global Impression-Severity Scale (CGI-S) [ Time Frame: Baseline, up to 24 weeks ] [ Designated as safety issue: No ]
Change from baseline up to 24 weeks in 16-Item Negative Symptom Assessment (NSA-16) [ Time Frame: Baseline, up to 24 weeks ] [ Designated as safety issue: No ]
Number of Participants with 30% decrease in PANSS total score [ Time Frame: Baseline up to 24 weeks ] [ Designated as safety issue: No ]
Number of Participants with suicidal behaviors and ideations measured by Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Baseline to 24 weeks ] [ Designated as safety issue: Yes ]
Time to discontinuation [ Time Frame: Baseline up to 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	670
Study Start Date:	April 2011
Study Completion Date:	October 2012
Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: LY2140023 Double Blind Phase: 40 mg administered orally, given twice daily for 24 weeks. Dose may be adjusted to a minimum of 20 mg and a maximum of 80 mg. Open Label Phase: 40 mg administered orally, given twice daily for an additional 28 weeks.	Drug: LY2140023 Administered orally
Active Comparator: Aripiprazole Double Blind Phase: 15 mg administered orally, given once daily for 24 weeks. Dose can be adjusted to a minimum of 10 mg or a maximum of 30 mg. Open Label Phase: LY2140023, 40 mg administered orally, given twice daily for an additional 28 weeks.	Drug: LY2140023 Administered orally Drug: Aripiprazole Administered orally

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
Female patients of childbearing age must test negative for pregnancy at screening and agree to use single, effective, medically acceptable method of birth control
Patients must require initiation of or modification to current antipsychotic treatment as outpatients
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 own informed consent

Exclusion Criteria:

Have been on treatment with aripiprazole in the past 2 months or are aripiprazole nonresponders
Patients who are pregnant, nursing, or intend to become pregnant within 30 days of completing the study
Hospitalized within 2 weeks of screening or have been hospitalized for an exacerbation of symptoms of schizophrenia with a discharge date in the past 2 months
Patients who are actively suicidal
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 who have had electroconvulsive therapy (ECT) within 3 months prior to screening or will have ECT at any time during the study
Patients with known medical history of Human Immunodeficiency Virus positive (HIV+) status
Test positive for (1) Hepatitis C virus antibody or (2) Hepatitis B surface antigen (HBsAg) with or without positive Hepatitis B core total antibody
Patients with a corrected QT interval (Bazett's; QTcB)>450 msec (male) or >470 msec (female) at screening
Patients who have a history of inadequate clinical response to antipsychotic treatment for schizophrenia
Patients who have received treatment with any depot formulation of an antipsychotic medication within 1 dosing interval, minimum of 4 weeks, prior to screening
Are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an investigational product or unapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Have any other psychiatric diagnoses in addition to schizophrenia
Have previously completed or withdrawn from this study, or any other study investigating LY2140023 or any predecessor molecules with glutamatergic activity
Patients who have received an adequate treatment trial, in the opinion of the investigator, with clozapine at doses greater than 200 mg daily within 12 months prior to screening, or who have received any clozapine at all during the month before screening
Diagnosis of substance-induced psychosis within 7 days of screening (or at any time during the study)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01328093

Show 51 Study Locations

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:	NCT01328093 History of Changes
Other Study ID Numbers:	14211, H8Y-MC-HBDE
Study First Received:	March 31, 2011
Last Updated:	January 11, 2013
Health Authority:	United States: Food and Drug Administration Austria: Federal Office for Safety in Health Care Belgium: Federal Agency for Medicinal Products and Health Products Belgium: Ethics Committee France: Ministry of Health Germany: Federal Institute for Drugs and Medical Devices Poland: Ethics Committee Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: National Medicines Agency Spain: Agencia Española de Medicamentos y Productos Sanitarios Sweden: Medical Products Agency

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 16, 2013