A Study in Schizophrenia Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01086748
First received: March 12, 2010
Last updated: September 18, 2012
Last verified: May 2012

March 12, 2010
September 18, 2012
March 2010
May 2012   (final data collection date for primary outcome measure)
  • A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in overall schizophrenia population [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in a genetic subgroup of schizophrenia patients [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01086748 on ClinicalTrials.gov Archive Site
  • A change from baseline in the Personal and Social Performance (PSP) score in the overall schizophrenia population [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline in the Personal and Social Performance (PSP) score in a genetic subgroup of schizophrenia patients [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline in the PANSS positive scale [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline in the PANSS negative scale [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline in PANSS General Psychopathology subscale [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline in the Clinical Global Impression-Severity Scale (CGI-S) [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline in the 16-item Negative Symptoms Assessment (NSA-16) [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline in the Montgomery-Ǻsberg Depression Rating Scale (MADRS) [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • PANSS total score [ Time Frame: up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in a female patients [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • Rate of discontinuation [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • Time to discontinuation [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline on the EuroQol - 5 Dimensions (EQ-5D) Questionnaire [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline on resource utilization, as measured by the Schizophrenia Resource Use Model (S-RUM) [ Time Frame: Baseline up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline on functional capacity, as measured by the Subjective Well-Being Under Neuroleptic Treatment Scale - Short Form (SWN-S) [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline in Barnes Akathisia Scale (BAS) [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline in Simpson-Angus Scale (SAS) [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline in Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A mean change from baseline in Prolactin levels [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: Yes ]
  • A change from baseline in weight [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Number of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 7 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Change from baseline in electrocardiogram parameters [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: Yes ]
  • A change from baseline in neurological examination [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Statistically different changes in vital signs from baseline [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Statistically different changes in lab values from baseline [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Population pharmacokinetics (PK) of LY2140023 [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline in Columbia- Suicide Severity Rating Scale (C-SSRS) [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: Yes ]
  • A change from baseline in the Personal and Social Performance (PSP) score in the overall schizophrenia population [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline in the Personal and Social Performance (PSP) score in a genetic subgroup of schizophrenia patients [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline in the PANSS positive scale [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline in the PANSS negative scale [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline in PANSS General Psychopathology subscale [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline in the Clinical Global Impression-Severity Scale (CGI-S) [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline in the 16-item Negative Symptoms Assessment (NSA-16) [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline on the MATRICS Consensus Cognitive Battery (MCCB) [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline in the Montgomery-Ǻsberg Depression Rating Scale (MADRS) [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • PANSS total score [ Time Frame: up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score in a female patients [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • Rate of discontinuation [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • Time to discontinuation [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline on the EuroQol - 5 Dimensions (EQ-5D) Questionnaire [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • resource utilization, as measured by the Schizophrenia Resource Use Model (S-RUM) [ Time Frame: up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline on functional capacity, as measured by UCSD Performance-based Skills Assessment - Brief Version (UPSA-B) [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline on functional capacity, as measured by the Subjective Well-Being Under Neuroleptic Treatment Scale - Short Form (SWN-S). [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline in Barnes Akathisia Scale (BAS) [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline in Simpson-Angus Scale (SAS) [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline in Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A mean change from baseline in Prolactin levels [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: Yes ]
  • A change from baseline in weight [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Number of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 7 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Change from baseline in electrocardiogram parameters [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: Yes ]
  • A change from baseline in neurological examination [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Statistically different changes in vital signs from baseline [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Statistically different changes in lab values from baseline [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: Yes ]
  • Population pharmacokinetics (PK) of LY2140023 [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: No ]
  • A change from baseline in Columbia- Suicide Severity Rating Scale (C-SSRS) [ Time Frame: baseline, up to 7 weeks of treatment ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Study in Schizophrenia Patients
A Phase 2, Multicenter, Double-Blind, Placebo-Controlled Comparator Study of 2 Doses of LY2140023 Versus Placebo in Patients With DSM-IV-TR Schizophrenia

An inpatient/outpatient study to see if LY2140023 is better than placebo in acutely ill patients with schizophrenia.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Risperidone
    Administered orally.
  • Drug: Placebo
    Administered orally.
  • Drug: LY2140023
    Administered orally.
  • Experimental: 160 mg LY2140023
    80 mg LY2140023 administered orally, twice daily (BID) for up to 7 weeks.
    Intervention: Drug: LY2140023
  • Active Comparator: 4 mg Risperidone
    2 mg risperidone administered orally, BID for up to 7 weeks.
    Intervention: Drug: Risperidone
  • Placebo Comparator: Placebo
    Placebo administered orally, BID for up to 7 weeks.
    Intervention: Drug: Placebo
  • Experimental: 80 mg LY2140023
    40 mg LY2140023 administered orally, BID for up to 7 weeks.
    Intervention: Drug: LY2140023
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
880
May 2012
May 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
  • Willing to participate in a minimum of 3 weeks of inpatient hospitalization and this must be appropriate for the patient in the clinical judgment 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. 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 2 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.
  • Treatment with clozapine at doses greater than 200 mg daily within 12 months prior to entering the study, or who have received any clozapine at all during the month before entering the study
  • Patients currently receiving treatment (within 1 dosing interval, minimum of 4 weeks, prior entering the study) with a depot formulation of an antipsychotic medication.
  • 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, uncontrolled 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 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
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Croatia,   Russian Federation
 
NCT01086748
11958, H8Y-MC-HBBM
Yes
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
May 2012

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