Schizophrenia or Schizoaffective Disorder
Conditions
Interventions
Product Name: IM olanzapine depot
Product Code: LY170053
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: Not available
CAS Number: 221373-18-8
Other descriptive name: ola
Sponsors
Eli Lilly and Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Male or female patients, at least 18 and no more than 76 years of age. [2] Female patients of childbearing potential must be using a medically accepted means of contraception. [3] Each patient must have a level of understanding sufficient to complete all tests and examinations required by the protocol. [4] Each patient (or the patient’s legal representative) must understand the nature of the study and must sign an informed consent document. [5] Patients must have schizophrenia that meets disease diagnostic criteria as defined in DSM-IV or DSM-IV-TR Sections 295.10, 295.20, 295.30, 295.60, or 295.90, or schizoaffective disorder (295.70), at the time of study entry. [6] Previous completion (within 10 days) of another IM olanzapine depot study, if permitted by that study’s protocol. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: [7] Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. [8] Are employed by Lilly (that is, employees, temporary contract workers, or designees responsible for conducting the study). Immediate family of Lilly employees may participate in Lilly-sponsored clinical trials, but are not permitted to participate at a Lilly facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. [9] Patients who have previously withdrawn from this study. [10] Have received treatment within the last 30 days with a drug (not including study drug or intramuscular rapid acting formulation of olanzapine) that has not received regulatory approval for any indication at the time of study entry. [11] Patients who have experienced clinically significant adverse events while treated with olanzapine that would preclude the use of the long-acting depot formulation. [12] Judged clinically to be at significant suicidal or homicidal risk and/or requires manual or chemical restraint. [13] Female patients who are either pregnant or breast-feeding. [14] Known uncorrected narrow-angle glaucoma. [15] History of allergic reaction to olanzapine. [16] One or more seizures without a clear and resolved etiology are exclusionary. However, if the patient has had one or more seizures in the past with an identifiable etiology, and that etiology has been resolved, the patient may be enrolled. [17] Known history of agranulocytosis (absolute neutrophil count <500mm3) during the patient’s lifetime. [18] Treatment with clozapine within 4 weeks prior to Visit 1. [19] Serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months. This includes hepatic (specifically any degree of jaundice), renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic diseases (specifically current agranulocytosis with an absolute neutrophil count <500mm3). [20] Patients with acute, serious or unstable medical conditions, including (but not limited to) inadequately controlled diabetes, hepatic insufficiency, acute systemic infection or immunologic disease, and cardiovascular disorders. [21] Known uncorrected hypothyroidism or hyperthyroidism. [22] DSM-IV or DSM-IV-TR substance (except nicotine and caffeine) dependence within the past 30 days. [23] Treatment with remoxipride within 6 months (180 days) prior to Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ·To assess long-term efficacy of IM olanzapine depot in patients diagnosed with schizophrenia or schizoaffective disorder by measuring Positive and Negative Syndrome Scale (PANSS) Total, PANSS Positive, PANSS Negative, PANSS General Psychopathology Subscales, Clinical Global Impression-Severity of Illness (CGI-S), and Clinical Global Impression-Improvement of Illness (CGI-I) ·To assess long-term impact of IM olanzapine depot on quality of life in patients diagnosed with schizophrenia or schizoaffective disorder, as measured by the Heinrichs-Carpenter Quality of Life Scale (QLS), Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), Resource Utilization, Hospitalization Inventory, Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S), and Patient Satisfaction with Medication Questionnaire-Modified (PSMQ) ·To characterize the pharmacokinetics of IM olanzapine depot during long-term treatment ;Primary end point(s): See primary objective. Collection of all data on laboratory values, vital signs, electrocardiograms (ECGs), adverse events in line with Lilly Company policy. Extrapyramidal symptoms (EPS) will be assessed by observations of the patients and administration of the following formal rating scales: the Barnes Akathisia Scale, the Simpson-Angus Scale, and the Abnormal Involuntary Movement Scale (AIMS). Health outcomes will be assessed by using the QLS, SF-36, Resource Utilization, Hospitalization Inventory, SWN-S, and PSMQ. Efficacy assessments include change from baseline to endpoint in the investigator-rated PANSS Total and the subtotals, CGI-S, and endpoint scores in CGI-I.;Main Objective: The primary objective of Study F1D-MC-HGKB is to assess the long-term safety of IM olanzapine depot in patients diagnosed with schizophrenia or schizoaffective disorder by monitoring laboratory values, vital signs, electrocardiograms (ECGs), adverse events, and extrapyramidal symptoms (EPS). | — |
Countries
Belgium, Czech Republic, Italy, Slovakia, Spain, Sweden
Outcome results
None listed