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Trial record 7 of 24 for:    LY2140023

A Comparison Study of LY2140023 and Aripiprazole in Schizophrenia Patients

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ClinicalTrials.gov Identifier: NCT01328093
Recruitment Status : Terminated (The decision to stop the trial was based on efficacy results in the overall schizophrenia participant population.)
First Posted : April 4, 2011
Last Update Posted : January 21, 2013
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE March 31, 2011
First Posted Date  ICMJE April 4, 2011
Last Update Posted Date January 21, 2013
Study Start Date  ICMJE April 2011
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2011)
Change from baseline to 24 weeks in body weight [ Time Frame: Baseline, 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01328093 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2011)
  • Proportion of participants with clinically significant weight change [ Time Frame: Baseline, 24 weeks ]
  • Change from baseline up to 24 weeks in Barnes Akathisia Scale (BAS) [ Time Frame: Baseline, up to 24 weeks ]
  • Change from baseline up to 24 weeks in Simpson-Angus Scale (SAS) [ Time Frame: Baseline, up to 24 weeks ]
  • Change from baseline up to 24 weeks in Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline, up to 24 weeks ]
  • 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 ]
  • Change from baseline up to 24 weeks in EuroQol-5 Dimensions Questionnaire (EQ-5D) [ Time Frame: Baseline, up to 24 weeks ]
  • Schizophrenia Resource Utilization Module (S-RUM) [ Time Frame: Baseline to 24 weeks ]
  • 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 ]
  • Change from baseline up to 24 weeks in Personal and Social Performance (PSP) Score [ Time Frame: Baseline, up to 24 weeks ]
  • Change from baseline up to 24 weeks in Clinical Global Impression-Severity Scale (CGI-S) [ Time Frame: Baseline, up to 24 weeks ]
  • Change from baseline up to 24 weeks in 16-Item Negative Symptom Assessment (NSA-16) [ Time Frame: Baseline, up to 24 weeks ]
  • Number of Participants with 30% decrease in PANSS total score [ Time Frame: Baseline up to 24 weeks ]
  • Number of Participants with suicidal behaviors and ideations measured by Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: Baseline to 24 weeks ]
  • Time to discontinuation [ Time Frame: Baseline up to 24 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison Study of LY2140023 and Aripiprazole in Schizophrenia Patients
Official Title  ICMJE 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
Brief Summary The purpose of this study is to determine whether weight gain will be significantly less in LY2140023 than aripiprazole in patients with schizophrenia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: LY2140023
    Administered orally
  • Drug: Aripiprazole
    Administered orally
Study Arms
  • 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.
    Intervention: Drug: LY2140023
  • 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.
    Interventions:
    • Drug: LY2140023
    • Drug: Aripiprazole
Publications * Adams DH, Zhang L, Millen BA, Kinon BJ, Gomez JC. Pomaglumetad Methionil (LY2140023 Monohydrate) and Aripiprazole in Patients with Schizophrenia: A Phase 3, Multicenter, Double-Blind Comparison. Schizophr Res Treatment. 2014;2014:758212. doi: 10.1155/2014/758212. Epub 2014 Mar 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: March 31, 2011)
670
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   France,   Germany,   Poland,   Puerto Rico,   Romania,   Spain,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01328093
Other Study ID Numbers  ICMJE 14211
H8Y-MC-HBDE ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP