An Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder - HGKB

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1000

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

[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[9]Patients who have previously withdrawn from this study.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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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