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Also known as LY170053, Zyprexa Adhera
Intramuscular Olanzapine Depot · 4 trials · 3 indications
The list of serious adverse events (SAE) and other non-serious adverse events (AE) are in Adverse Events Section.
Prolactin normal reference ranges for female: 2.0 - 29.0 nanograms per milliliter (ng/mL); male: 2.0 - 20.0 ng/mL. High value is defined as a change from a value less than or equal to the high limit at all baseline visits to a value greater than the high limit at any time after baseline.
High ALT is defined as a baseline value of \<3 times the upper limit of normal (ULN) to ≥3 times the ULN at any time post baseline. High AST is defined as a baseline value of \<5 times the ULN to ≥5 times the ULN at any time post baseline. High total bilirubin is defined as a baseline value of \<2 times the ULN to ≥2 times the ULN at any time post baseline.
Normal to high fasting glucose ≤100 milligrams per deciliter (mg/dL) at baseline to ≥126 mg/dL any time post baseline.
Normal to high fasting total cholesterol ≤200 mg/dL at baseline to ≥240 mg/dL any time post baseline. Fasting triglycerides \<150 mg/dL at baseline to ≥200 mg/dL and \<500 mg/dL any time post baseline.
Mean change in weight from baseline to last observation carried forward (LOCF) endpoint.
PCS weight gain is defined as a ≥7% increase in weight from baseline.
Extrapyramidal symptoms are defined as Simpson-Angus total score (SAS) \>3 at any post-baseline visit; Barnes Akathisia Scale (BAS) global score ≥2 at any post-baseline visit; A score ≥3 for any of Abnormal Involuntary Movement Scale (AIMS) for items 1-7 or a score ≥2 for any two of these items. Score for SAS is 0-4 for each of the 10 questions, with 0=normal and 4=extreme. The possible total score for SAS is 0-40. Possible score for BAS is 0-5, with 0=absent and 5=sever. Score 0-4 for each item of AIMS, with 0 =none and 4= sever. Possible total score for items 1-7 is 0-28.
| Arm | Type | Description |
|---|---|---|
| Intramuscular Olanzapine Depot | EXPERIMENTAL | Intramuscular (IM) olanzapine depot flexible dosing and flexible interval |
| Name | Type | Description |
|---|---|---|
| Intramuscular olanzapine depot | DRUG | 45-405 milligram (mg), intramuscular injection, on a 2-, 3-, or 4-week interval. |
| Placebo | DRUG | - |
| Oral Olanzapine | DRUG | - |
Inclusion Criteria: * Patients must have schizophrenia * Female patients of childbearing potential must be using a medically accepted means of contraception * Patients must have completed (within 10 days) another IM olanzapine depot study if permitted by that study's protocol. Exclusion Criteria: ...
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Intramuscular Olanzapine Depot is an investigational long-acting injectable formulation of olanzapine being developed for the treatment of schizophrenia and schizophrenic disorders. It is administered by intramuscular injection and is intended to provide sustained delivery of the antipsychotic medication olanzapine.
Intramuscular Olanzapine Depot is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company has conducted clinical trials evaluating this depot formulation in patients with schizophrenia and related disorders.
Intramuscular Olanzapine Depot has completed Phase 3 clinical trials. These trials were randomized, double-blind studies, although the control type was listed as uncontrolled. The drug remains investigational and is not approved by regulatory authorities, as it is still in clinical development.
Intramuscular Olanzapine Depot has been studied in several completed trials. NCT00088465 was an open-label Phase 3 study in schizophrenia or schizoaffective disorder with 931 participants. NCT00088478 compared the depot to placebo in schizophrenia with 402 participants. NCT00088491 compared it to oral olanzapine and low-dose depot with 1205 participants.
Intramuscular Olanzapine Depot works by delivering olanzapine, an atypical antipsychotic, in a slow-release formulation. Olanzapine acts on multiple neurotransmitter receptors in the brain, including dopamine and serotonin receptors, which helps manage symptoms of schizophrenia. The depot formulation allows for less frequent dosing compared to daily oral medication.
Intramuscular Olanzapine Depot is a different formulation from oral olanzapine, though it contains the same active drug. The depot is designed for intramuscular injection and provides prolonged release of olanzapine over time, whereas oral olanzapine is taken daily by mouth. Clinical trials have directly compared the two formulations in patients with schizophrenia.