Schizophrenia MedDRA version: 14.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patients are male or female, 18 to 65 years of age (inclusive) at study entry, with a diagnosis of schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR; APA 2000) •Female patients of childbearing potential must test negative for pregnancy at Visit 1 and agree to use a single, effective, medically acceptable method of birth control. •Patients must require a modification of antipsychotic medication or the initiation of antipsychotic medication, as indicated by their present clinical psychiatric status and/or treatment tolerability as outpatients. •Patients must be considered reliable and have a level of understanding sufficient to perform all tests and examinations required by the protocol, and be willing to perform all study procedures. •Patients must be able to understand the nature of the study and have given 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 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an investigational product or nonapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. •Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. •Are Lilly employees •Patients for whom treatment with LY2140023, as specified in this protocol, is relatively or absolutely clinically contraindicated •Are hospitalized for an exacerbation of symptoms of schizophrenia with a discharge date in the past 2 months of Visit 1 •Have a CGI-S score >4 at Visit 1 •Have any other current Axis I psychiatric diagnoses in addition to schizophrenia •Have previously completed or withdrawn from this study, or any other study investigating LY2140023 or any predecessor molecules with glutamatergic activity •Patients who have received an adequate treatment trial, in the opinion of the investigator, with clozapine at doses >200 mg daily within 12 months prior to Visit 1, or who have received any clozapine at all during the month before Visit 1 •Patients who have a history of an inadequate clinical response, in the opinion of the investigator, to antipsychotic treatment for schizophrenia. For this study, inadequate clinical response is defined as persistent and moderately severe hallucinations, delusions, or thought disorder after completion of 2 or more antipsychotic medication trials of at least 8 weeks duration the past 12 months prior to Visit 1. •Patients who require concomitant treatment with any other medication with primary central nervous system (CNS) activity, other than those allowed as specified in Section 9.8 (Concomitant Therapy) of the protocol or with any other medication specifically excluded in the Concomitant Medications attachment (Attachment 3) of the protocol •Patients who have received treatment with any depot formulation of an antipsychotic medication within 1 dosing interval, minimum of 4 weeks, prior to Visit 1 •Patients who are actively suicidal •DSM-IV-TR diagnosis of substance dependence or substance abuse (except nicotine and caffeine) within the 6 months prior to Visit 1 •Diagnosis of substance-induced psychosis by DSM-IV-TR criteria within 7 days of Visit 1 (or at any time during the study) •Female patients who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study •Have known, uncorrected, narrow-angle glaucoma •Have a history of 1 or more seizures •Patients who have had electroconvulsive therapy (ECT) within 3 months of Visit 1 or who will have ECT at any time during the study •Patients with untreated hyper- or hypothyroidism. •Have leukopenia or a history of leukopenia without a clear and resolved etiology, or known history of agranulocytosis during the patient’s lifetime •Patients with known medical history of human immunodeficiency virus positive (HIV+) status •Patients who 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 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 •Patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess whether LY2140023, when administered in an acute-treatment trial with flexible doses (40 or 80 mg) BID is associated with physical dependence, as measured by the occurrence of withdrawal symptoms during a randomized withdrawal phase in patients diagnosed with schizophrenia. ;Secondary Objective: •To characterize the symptoms observed in randomized patients treated with LY2140023 compared with those on placebo during the withdrawal phase using Rickels checklist •To evaluate symptoms in randomized patients treated with LY2140023 compared with those on placebo during the withdrawal phase using the CIWA-Ar scale •To evaluate the safety and tolerability of randomized LY2140023 compared with placebo during the withdrawal phase •To assess the safety and tolerability of randomized LY2140023 during the open-label treatment phase •To assess the efficacy of randomized LY2140023 compared with placebo during the withdrawal phase using the CGI-S and BPRS scales •To assess whether LY2140023, when administered in flexible doses, is associated with physical dependence within a prospectively defined subpopulation. ;Primary end point(s): Maximum of the 3-day moving average of the patient’s total score on the Discontinuation Symptom Checklist Modified Rickels;Timepoint(s) of evaluation of this end point: Up to 3 weeks after randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Change during the open label treatment phase as measured by: the area under the curve (AUC) for the total score and on each item of the Discontinuation Symptom Checklist-Modified Rickels over time, the Clinical Institute Withdrawal Assessment of Alcohol (CIWA-Ar) scale, treatment-emergent adverse events (TEAEs), extrapyramidal symptoms (EPS), the Barnes Akathisia Scale (Barnes), Simpson-Angus Scale (SAS), Abnormal Involuntary Movement Scale (AIMS), laboratory tests, prolactin, vital signs, electrocardiograms (ECGs), neurological examination, the Columbia-Suicide Severity Rating Scale (C-SSRS) •Change from randomization up to 3 weeks as measured by: the area under the curve (AUC) for the total score and on each item of the Discontinuation Symptom Checklist-Modified Rickels over time, the Clinical Institute Withdrawal Assessment of Alcohol (CIWA-Ar) scale, treatment-emergent adverse events (TEAEs), extrapyramidal symptoms (EPS), the Barnes Akathisia Scale (Barnes), Simpson-Angus Scale (SAS), Abnormal Involuntary Movement Scale (AIMS), laboratory tests, prolactin, vital signs, electrocardiograms (ECGs), neurological examination, the Columbia-Suicide Severity Rating Scale (C-SSRS), the Clinical Global Impression - Severity Scale (CGI-S) and the Brief Psychiatric Rating Scale (BPRS) •Occurrence of withdrawal symptoms during the randomized withdrawal phase ;Timepoint(s) of evaluation of this end point: Up to 3 weeks after randomization and up to 4 weeks after entering treatment | — |
Countries
Argentina, Brazil, Greece, United States
Contacts
Public ContactClinical Trial Information
Eli Lilly
Outcome results
None listed