Phase 3
Completed N=931
Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder
Schizophrenic Disorders · schizoaffective disorder
Source: ClinicalTrials.gov NCT00088465 ↗
Enrolled (actual)
931
Serious AEs
18.3%
Results posted
Jan 2012
Primary outcomePrimary: Number of Participants With Adverse Events (AE) — 501; 170 participants
Summary
This is a long-term, open-label clinical study designed to enable longer-term treatment of patients completing other clinical studies with intramuscular olanzapine depot.
Key objectives of the study are to:
* Determine how well intramuscular (IM) olanzapine depot works during long-term treatment,
* Evaluate the safety and tolerability of IM olanzapine depot during long-term treatment,
* Determine the blood levels of IM olanzapine depot in patients during long-term treatment
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AE) |
501; 170 | — |
| PRIMARY Number of Participants With Treatment-Emergent Abnormal High Prolactin at Any Time Post Baseline |
100 | — |
| PRIMARY Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline |
61; 55; 24 | — |
| PRIMARY Number of Participants Having Normal Fasting Baseline Glucose Value With Treatment-Emergent High Fasting Glucose at Any Time Post Baseline |
20 | — |
| PRIMARY Number of Participants Having Normal Fasting Baseline Lipid Value With Treatment-Emergent High Fasting Lipid at Any Time Post Baseline |
28; 41 | — |
| PRIMARY Change From Baseline in Weight at Month 76 Endpoint |
2.10 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant (PCS) Weight Gain at Month 76 Endpoint |
373 | — |
| PRIMARY Number of Participants With Extrapyramidal Symptoms at Any Time |
66; 34; 28 | — |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint |
0.30 | — |
| SECONDARY Change From Baseline in PANSS Positive Scores at Month 76 Endpoint |
0.21 | — |
| SECONDARY Change From Baseline in PANSS Negative Scores at Month 76 Endpoint |
-0.08 | — |
| SECONDARY Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint |
0.19 | — |
| SECONDARY Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Scores at Month 72 Endpoint |
-0.17 | — |
| SECONDARY Change From Baseline in the Heinrichs-Carpenter Quality of Life Scale (QLS) Total Score at Month 76 Endpoint |
6.75 | — |
| SECONDARY Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint |
0.94; -0.36 | — |
| SECONDARY Number of Psychiatric Visits |
14102 | — |
| SECONDARY Days of Hospitalization |
2386; 35587; 134 | — |
| SECONDARY Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) at Month 76 Endpoint |
0.86 | — |
| SECONDARY Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint |
73.2; 66.8; 73.3 | — |
| SECONDARY Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year |
2.23; 2.51; 2.45; 2.65; 2.57; 2.59 | — |
Eligibility Criteria
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
- Patients must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to study entry
- Female patients must not be pregnant or breast-feeding
- Patients must not be experiencing acute, serious or unstable medical conditions other than schizophrenia or schizoaffective disorder
- Patients must not have a substance (except nicotine or caffeine) dependence within the past 30 days
Data sourced from ClinicalTrials.gov (NCT00088465). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.