Schizophrenia MedDRA version: 9.1 Level: LLT Classification code 10039626 Term: Schizophrenia
Conditions
Interventions
Product Name: mGlu2/3 Agonist Prodrug II
Product Code: LY2140023
Pharmaceutical Form: Tablet
CAS Number: 635318-55-7
Current Sponsor code: LY2140023
Other descriptive name: mGlu2/3 Agonist Prodrug II
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Have a diagnosis of schizophrenia as defined in the DSM-IV-TR; APA 2000 and confirmed by the SCID. [2] Male or female patients, 18 to 65 years of age, inclusive [3] Female patients test negative for pregnancy at Visit 1 and agree to use a reliable method of birth control during the study. [4] Patients must: • in the opinion of the investigator, require a switch to another antipsychotic medication as clinically indicated or initiation of an antipsychotic medication; • be willing and able to be hospitalized, or to remain hospitalized (if already hospitalized), for up to 17 days (3 days during the placebo lead-in period and the first 2 weeks of active treatment); • be patients for whom, in the investigator’s clinical judgment, there is an expectation at the time of enrollment that the patient will be able to be discharged from the hospital at Visit 5, after 17 days of inpatient treatment during the placebo lead-in phase and first 2 weeks of active treatment; • have a symptom score =4 on at least 3 items of the PANSS Negative subscale or a score =5 on at least 2 items of the PANSS Negative subscale. • have evidence of functional impairment [5] 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. [6] Patients must be able to understand the nature of the study and havegiven their own informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: [7] Are investigator site personnel directly affiliated with this study and/or their immediate families [8] Are Lilly employees [9] Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. [10] Have previously completed or withdrawn from this study or any other study investigating LY2140023 [11] Patients for whom treatment with aripiprazole, LY2140023, olanzapine, or risperidone, is contraindicated [12] Patients who are experiencing severity of symptoms as reflected by a CGI-S score > 4 [13] Patients who have received treatment with clozapine at doses greater than 200 mg daily within 12 months prior to Visit 1, or who have received any clozapine at all during the month before Visit 1 [14] Patients who have, in the opinion of the investigator, a history of an inadequate response to 2 or more adequate antipsychotic medication trials of at least 8 weeks duration in the past 12 months prior to Visit 1. [15] Patients who require concomitant treatment with any other medication with primary CNS activity, other than those allowed as specified in the Protocol [16] Patients receiving treatment with depot antipsychotic medication within 1 dosing interval, minimum of 4 weeks, prior to Visit 1. [17] Patients have answered ‘yes’ to either Question 4 or Question 5 on the "Suicidal Ideation" portion of the C–SSRS, or answer "yes" to any of the suicide-related behaviors on the "Suicidal Behavior" portion of the C–SSRS; and the ideation or behavior occurred within the past month. [18] DSM-IV-TR diagnosis of substance dependence or substance abuse within the 6 months prior to Visit 1. [19] Diagnosis of substance-induced psychosis by DSM-IV-TR criteria within 7 days of Visit 1 [20] Female patients who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study. [21] Have known uncorrected narrow-angle glaucoma. [22] Have a history of one or more seizures [23] Patients who have had ECT within 3 months of Visit 1 or who will have ECT at any time during the study. [24] A diagnosis of Parkinson’s disease, dementia-related psychosis, or related disorders [25] Patient with untreated hyperthyroidism or hypothyroidism needing a thyroid hormone supplement who have not been on a stable dose of medication for at least 2 months prior to Visit 1. [26] Have leukopenia or history of leukopenia without a clear and resolved etiology, or known history of agranulocytosis during the patient’s lifetime. [27] Patients with known HIV+ status [28] 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 positive hepatitis B core antibody test and negative HBsAg may be included in the study if ALT/SGPT and AST/SGOT levels are less than 2 times the upper limit of normal (ULN) and total bilirubin is within the normal range of the central laboratory. [29] Patients with ALT/SGPT or AST/SGOT values >2 times ULN of the performing laboratory, or total bilirubin values >1.5 times the ULN of the performing laboratory at Visit 1. [30] Patients with acute, serious, or unstable medical conditions, including, but not limited to, inadequately controlled diabetes (hemoglobin A1c (HbA1c) >8%), severe hypertriglyceridemia (fa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to 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.;Secondary Objective: • to further evaluate the safety and tolerability of LY2140023 compared with SOC treatment, as assessed by the following measures: TEAEs, EPS, EEGs, ECGs, neurological examination, changes in vital signs, weight, and laboratory values, and solicited questioning of suicide-related adverse events using the C-SSRS. • to determine the PK and exposure variability of LY2140023 and LY404039 in patients with schizophrenia. • to examine the long-term efficacy of LY2140023 compared with standard of care, as measured by the following scales: PANSS, CGI-S, NSA-16, MCCB, and the MADRS. • to assess if LY2140023 demonstrates improvement in health outcome measures, including quality of life, functioning, resource utilization, and patient-reported outcomes compared to standard of care. • to evaluate rates of response, remission, and relapse among patients treated with LY2140023 compared to those on standard-of-care treatment;Primary end point(s): The primary safety outcome is the time to discontinuation due to AEs. Kaplan-Meier (1958) estimated survival curves of time to discontinuation (measured in days) for AEs will be compared between LY2140023 and standard of care. | — |
Countries
Germany
Outcome results
None listed