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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
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: Risperidone
Drug: Placebo
Drug: LY2140023
Phase 2

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 2, Multicenter, Double-Blind, Placebo-Controlled Comparator Study of 2 Doses of LY2140023 Versus Placebo in Patients With DSM-IV-TR Schizophrenia

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 880
Study Start Date: March 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 160 mg LY2140023
80 mg LY2140023 administered orally, twice daily (BID) for up to 7 weeks.
Drug: LY2140023
Administered orally.
Active Comparator: 4 mg Risperidone
2 mg risperidone administered orally, BID for up to 7 weeks.
Drug: Risperidone
Administered orally.
Placebo Comparator: Placebo
Placebo administered orally, BID for up to 7 weeks.
Drug: Placebo
Administered orally.
Experimental: 80 mg LY2140023
40 mg LY2140023 administered orally, BID for up to 7 weeks.
Drug: LY2140023
Administered orally.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01086748

  Show 28 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: NCT01086748     History of Changes
Other Study ID Numbers: 11958, H8Y-MC-HBBM
Study First Received: March 12, 2010
Last Updated: September 18, 2012
Health Authority: United States: Food and Drug Administration
Croatia: Ethics Committee
Croatia: Ministry of Health and Social Care
Germany: Ethics Commission
Germany: Ministry of Health
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014