| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00088465 | Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder | PHASE3 | COMPLETED | 931 | — | — | Aug 1, 2004 | Dec 1, 2010 | Jan 11, 2012 | 92 | United States, Argentina +23 |
| NCT00088491 | Comparison of Intramuscular Olanzapine Depot to Oral Olanzapine and Low-Dose Depot in Patients With Schizophrenia | PHASE3 | COMPLETED | 1,205 | — | — | Jun 1, 2004 | Oct 1, 2006 | Jun 22, 2007 | 4 | Finland, Turkey (Türkiye) |
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. |
| 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: ...