A Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients 


Tracking Information

Start Date  ICMJEApril 2009
Estimated Primary Completion DateJune 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2009)
Time to discontinuation. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ICMJE 
 (submitted: February 13, 2009)
Time to discontinuation. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Change HistoryComplete list of historical versions of study NCT00845026 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: March 23, 2009)
  • Extrapyramidal symptoms (EPS) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Electroencephalograms (EEGs) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Electrocardiograms (ECGs). [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Neurological examination. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Changes in vitals signs. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Changes in weight [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Changes in laboratory values [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Positive and Negative Syndrome Scale (PANSS). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression Severity Scale (CGI-S) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • 16-item Negative Symptoms Assessment (NSA-16). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • MATRICS Consensus Cognitive Battery (MCCB). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Montgomery-Asberg Depression Rating Scale (MADRS). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Health outcome as measured by quality of life, functioning, resource utilization, and patient-reported outcomes compared to standard of care. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Rate of response [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Rate of remission [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Rate of relapse [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJE 
 (submitted: February 13, 2009)
  • Extrapyramidal symptoms (EPS) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Electroencephalograms (EEGs) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Electrocardiograms (ECGs). [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Neurological examination. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Changes in vitals signs. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Changes in weight [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Changes in laboratory values [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Positive and Negative Syndrome Scale (PANSS). [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Clinical Global Impression Severity Scale (CGI-S) [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • 16-item Negative Symptoms Assessment (NSA-16). [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • MATRICS Consensus Cognitive Battery (MCCB). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Montgomery-Asberg Depression Rating Scale (MADRS). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Health outcome as measured by quality of life, functioning, resource utilization, and patient-reported outcomes compared to standard of care. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Rate of response [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Rate of remission [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Rate of relapse [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title  ICMJEA Safety Study Comparing LY2140023 to Atypical Antipsychotic Standard Treatment in Schizophrenic Patients.
Official Title  ICMJEA 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.
Brief Summary

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).

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety Study
Condition  ICMJESchizophrenia
Intervention  ICMJE
  • 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.
  • 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).
  • 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
  • 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).
Study Arms / Comparison Groups
  • LY2140023: Experimental
    Intervention: Drug: LY2140023
  • aripiprazole: Active Comparator
    Intervention: Drug: aripiprazole
  • olanzapine: Active Comparator
    Intervention: Drug: olanzapine
  • risperidone: Active Comparator
    Intervention: Drug: risperidone

Recruitment Information

Estimated Enrollment  ICMJE260
Estimated Completion DateJune 2010
Estimated Primary Completion DateJune 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages18 Years to 65 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559
Location Countries  ICMJEUnited States,   Germany,   Mexico,   Russian Federation

Administrative Information

NCT ID  ICMJENCT00845026
Responsible PartyChief Medical Officer, Eli Lilly
Study ID Numbers  ICMJE12648, H8Y-MC-HBBR
Study Sponsor  ICMJEEli Lilly and Company
Collaborators  ICMJE 
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
Information Provided ByEli Lilly and Company