Schizophrenia MedDRA version: 12.1 Level: LLT Classification code 10039626 Term: Schizophrenia
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Male or female patients, 18 to 65 years of age (inclusive) at the time of entry to the feeder study. [2] Must have met all entry criteria for, and have completed, an acute, placebo-controlled clinical trial of LY2140023 (such as Study H8Y-MC-HBBM, Study H8Y-MC-HBBN, Study H8Y-MC-HBBP, or other acute, placebo-controlled LY2140023 studies if allowed by the protocols for those studies). [3] Female patients of childbearing potential must agree to use a single, effective, medically acceptable method of birth control, specifically: an oral contraceptive combined pill, an implantable contraceptive, an injectable contraceptive, a contraceptive patch (for women =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: [9] Patients for whom treatment with olanzapine, risperidone, aripiprazole, quetiapine, or LY2140023, as specified in this protocol, is relatively or absolutely clinically contraindicated. [10] 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. [11] Patients who require concomitant treatment with any other medication with primary central nervous system activity, other than those allowed (as specified in Section 9.8 and Attachment HBBO.3). [12] Patients have answered ‘yes’ to either Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the "Suicidal Ideation" portion of the C–SSRS, or answer "yes" to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the "Suicidal Behavior" portion of the C–SSRS; and the ideation or behavior occurred within the past month. [13] Patients diagnosed (per DSM-IV-TR) with substance dependence or substance abuse (except nicotine and caffeine) within the 6 months prior to Visit 1. [14] Patients diagnosed (per DSM-IV-TR) with substance-induced psychosis within 7 days of Visit 1 (or at any time during the study). [15] Female patients who are pregnant, nursing, lactating or who intend to become pregnant within 30 days of completing the study. [16] Have known, uncorrected, narrow-angle glaucoma. [17] 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 (a single simple febrile seizure is defined as lacking focality and lasting less than 15 minutes, not associated with a CNS infection or severe metabolic disturbance). [18] Patients have a first-degree relative (that is, biological father, mother, brother, sister, or child) with history of idiopathic epilepsy. [19] Within 1 year of study enrollment, patients have a history of CNS infection, uncontrolled migraine, transient ischemic attack (TIA), or head trauma with loss of consciousness or a post-concussive syndrome. [20] Patients 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 EEG with paroxysmal (epileptiform) activity, for example, one that demonstrates 3 or more focal sharp or spike waves, any sharp and slow wave complex, or any epileptiform discharge that is rhythmic, sustained, or generalized; or as locally defined; • brain structural lesion, including developmental abnormalities, as determined by examination or previous imaging studies, that are consistent with a diagnosable neurologic disease or syndrome. [21] Patients who have had electroconvulsive therapy (ECT) within 3 months of Visit 1 or who will have ECT at any time during the study. [22] Patients with known Human Immunodeficiency Virus positive (HIV+) status. [23] Patients with acute, serious, or unstable medical conditions, including, but not limited to: inadequately controlled diabetes or severe hypertriglyceridemia; recent cerebrovascular accidents, acute systemic infection or immunologic disease, or unstable cardiovascular disorders (including ischemic heart disease); malnutrition, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (including Park
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 up to 52 weeks of LY2140023, given orally twice daily, compared with those on atypical antipsychotic standard-of-care treatment. Lack of tolerability is defined as discontinuation due to adverse events (AEs).;Secondary Objective: • to evaluate the safety and tolerability of LY2140023 compared with standard-of-care treatment up to 52 weeks. • to examine the long-term efficacy and outcomes of LY2140023 compared with standard-of-care treatment up to 52 weeks. • to further evaluate the safety and tolerability of LY2140023 compared with standard-of-care treatment over an additional 52 weeks in patients who have completed the first 52 weeks of Study Period I. • to further evaluate the maintenance of efficacy of LY2140023 compared with standard-of-care treatment over an additional 52 weeks in patients who have completed the first 52 weeks of Study Period I. • to assess whether LY2140023 demonstrates improvement compared with standard-of-care treatment in health outcome measures. • to assess the continued safety and tolerability of LY2140023 in Study Period II. • to examine the effect of genetic variation on response to treatment.;Primary end point(s): The primary safety outcome is the time to discontinuation due to AEs during the first year of Study Period I. | — |
Countries
Germany
Outcome results
None listed