A Study in Schizophrenic Patients

This study has been terminated.
(The decision to stop the trial was based on efficacy results in the overall schizophrenia participant population.)
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01125358
First received: May 17, 2010
Last updated: January 11, 2013
Last verified: November 2012

May 17, 2010
January 11, 2013
May 2010
September 2012   (final data collection date for primary outcome measure)
Clinical Utility Index (CUI) [ Time Frame: up to 7 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01125358 on ClinicalTrials.gov Archive Site
  • Change from baseline up to 7 week endpoint in the Positive and Negative Syndrome Scale (PANSS) total score, positive score, negative score, and psychopathology subscale [ Time Frame: Baseline, up to 7 weeks ] [ Designated as safety issue: No ]
  • Change from baseline up to 7 week endpoint in the Clinical Global Impression-Severity Scale (CGI-S) [ Time Frame: Baseline, up to 7weeks ] [ Designated as safety issue: No ]
  • Change from baseline up to 7 week endpoint in the 16-item Negative Symptoms Assessment (NSA-16) [ Time Frame: Baseline, up to 7weeks ] [ Designated as safety issue: No ]
  • The number of patients with statistically significant changes (treatment emergent ideation and behavior; improvement) based on the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline, up to 9 weeks ] [ Designated as safety issue: Yes ]
  • Rate of discontinuation [ Time Frame: Through 7 weeks ] [ Designated as safety issue: No ]
  • Change from baseline up to 7 week endpoint in the Positive and Negative Syndrome Scale (PANSS) total score, positive score, negative score, and psychopathology subscale [ Time Frame: Baseline, up to 7 weeks ] [ Designated as safety issue: No ]
  • Change from baseline up to 7 week endpoint in the Clinical Global Impression-Severity Scale (CGI-S) [ Time Frame: Baseline, up to 7weeks ] [ Designated as safety issue: No ]
  • Change from baseline up to 7 week endpoint in the 16-item Negative Symptoms Assessment (NSA-16) [ Time Frame: Baseline, up to 7weeks ] [ Designated as safety issue: No ]
  • Change from baseline up to 7 week endpoint on the MATRICS Consensus Cognitive Battery (MCCB) [ Time Frame: Baseline, up to 7weeks ] [ Designated as safety issue: No ]
  • Change from baseline up to 7 week endpoint in the Montgomery-Ǻsberg Depression Rating Scale (MADRS) [ Time Frame: Baseline, up to 7weeks ] [ Designated as safety issue: No ]
  • The number of patients with statistically significant changes (treatment emergent ideation and behavior; improvement) based on the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline, up to 9 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline up to 7 week endpoint on the EuroQol - 5 Dimensions (EQ-5D) Questionnaire [ Time Frame: Baseline, up to 7weeks ] [ Designated as safety issue: No ]
  • Change from baseline up to 7 week endpoint in Resource utilization, as measured by the Schizophrenia Resource Use Model (S-RUM) [ Time Frame: Baseline, up to 7weeks ] [ Designated as safety issue: No ]
  • Change from baseline up to 7 week endpoint on functional capacity, as measured by UCSD Performance-based Skills Assessment - Brief Version (UPSA-B) [ Time Frame: Baseline, up to 7weeks ] [ Designated as safety issue: No ]
  • Change from baseline up to 7 week endpoint on functional capacity, as measured by the Subjective Well-Being Under Neuroleptic Treatment Scale - Short Form (SWN-S) [ Time Frame: Baseline, up to 7weeks ] [ Designated as safety issue: No ]
  • Change from baseline up to 7 week endpoint in the Personal and Social Performance (PSP) score [ Time Frame: Baseline, up to 7weeks ] [ Designated as safety issue: No ]
  • Rate of discontinuation [ Time Frame: Through 7 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study in Schizophrenic Patients
A Multicenter, Double-Blind, Placebo-Controlled Study of 3 Doses of LY2140023 in Patients With DSM-IV-TR Schizophrenia

This study is designed to compare 3 doses of LY2140023 for the treatment of schizophrenia as assessed at endpoint (up to 7 weeks) using the Clinical Utility Index (CUI), a measure of efficacy, safety, and tolerability.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: LY2140023
    Administered orally, twice daily for up to 7 weeks of treatment
  • Drug: Placebo
    Administered orally, twice daily for up to 7 weeks of treatment
  • Experimental: 10 mg LY2140023
    Intervention: Drug: LY2140023
  • Experimental: 80 mg LY2140023
    Intervention: Drug: LY2140023
  • Experimental: 160 mg LY2140023
    Intervention: Drug: LY2140023
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
200
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR; APA 2000) (Disorganized, 295.10; Catatonic, 295.20; Paranoid 295.30; or Undifferentiated, 295.90) and confirmed by the Structured Clinical Interview for DSM-IV-TR (SCID)
  • Non pregnant female patients who agree to use acceptable birth control
  • At entry to the study must be considered moderately ill in the opinion of the investigator
  • 1 year history of Schizophrenia prior to entering the study
  • At study entry patients with a history of antipsychotic treatment must have a lifetime history of at least one hospitalization for the treatment of schizophrenia, not including the hospitalization required for study based on the investigator's clinical judgment. Patients who have never taken antipsychotic treatment may enter the study even without a history of hospitalization
  • At study entry patients with a history of antipsychotic treatment must have a history of at least one episode of illness exacerbation requiring an intensification of treatment intervention or care in the last 2 years, not including the present episode of illness. Patients who have never taken antipsychotic treatment may enter the study without a past history of illness exacerbation and intensification of treatment in the last 2 years
  • At study entry patients must have experienced an exacerbation of illness within the 4 weeks prior to entering the study, leading to an intensification of psychiatric care in the opinion of the investigator. If exacerbation occurs in patients who are presently hospitalized, the patient must not have been hospitalized longer than 60 days at entry of the study

Exclusion Criteria:

  • Participated in any clinical trial with any pharmacological treatment intervention for which they received a study-related medication in the 6 months prior to visit 1
  • Previously completed or withdrawn from this study, or any other study investigating LY2140023 or any predecessor molecules with glutamatergic activity
  • Have any known history of receiving treatment with clozapine at any dose, as determined at baseline
  • Have received treatment with a depot formulation of an antipsychotic medication within the 6 months prior entering the study
  • Patients who are currently suicidal
  • Females who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study
  • Patients with uncorrected narrow-angle glaucoma, uncontrolled diabetes, certain diseases of the liver, renal insufficiency, untreated thyroid condition or other serious or unstable illnesses
  • Have a history of one or more seizures, except for those who experienced a single simple febrile seizure between ages 6 months and 5 years
  • Patients are excluded if their, biological father, mother, brother, sister, or child has a history of idiopathic epilepsy
  • Within 1 year of study enrollment, patients have a history of central nervous system infection, uncontrolled migraine, transient ischemic attack (TIA), or head trauma with loss of consciousness or a post-concussive
  • Patients are excluded if they have a lifetime history of any of the following:

    • head trauma, stroke, or central nervous system (CNS) infection with persistent neurological deficit (focal or diffuse);
    • brain surgery;
    • an electroencephalogram with paroxysmal (epileptiform) activity, or
    • brain structural lesion, including developmental abnormalities, as determined by examination or previous neuroimaging studies that are consistent with a diagnosable neurological disease or syndrome
  • Electroconvulsive therapy (ECT) within 3 months of entering the study or who will have ECT at any time during the study
  • Leukopenia
  • Medical history of Human Immunodeficiency Virus positive (HIV+) status
  • Higher than normal blood prolactin levels
  • Certain electrocardiogram results
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan,   Korea, Republic of,   Taiwan
 
NCT01125358
13560, H8Y-JE-HBDC
Yes
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4459 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
November 2012

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