Phase 3
Completed N=101
Safety and Efficacy of Olanzapine in the Long-term Treatment for Bipolar I Disorder, Depressed
Source: ClinicalTrials.gov NCT00618748 ↗Enrolled (actual)
101
Serious AEs
2.0%
Results posted
Jun 2011
Primary outcomePrimary: Percentage of Participants With Adverse Events Leading to Discontinuation — 7.1; 12.0; 40.0 percentage of participants
Summary
To assess the efficacy and safety of olanzapine in the long-term treatment for patients with bipolar I disorder, depressed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events Leading to Discontinuation |
7.1; 12.0; 40.0 | — |
| SECONDARY Change From Baseline in Glucose and Lipid Panel at Week 24 or Week 48 Endpoint |
0.03; 0.37; 0.68; 0.033; 0.040; 0.086 | — |
| SECONDARY Change From Baseline in Weight at Week 24 or Week 48 Endpoint |
0.29; 0.92; 5.36 | — |
| SECONDARY Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 24 or Week 48 Endpoint |
-0.2; -0.4; -5.8 | — |
| SECONDARY Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 24 or Week 48 Endpoint |
0.4; -0.2; -0.1 | — |
| SECONDARY Change From Baseline in Clinical Global Improvement- Bipolar (CGI-BP) at Week 24 or Week 48 Endpoint |
-0.1; 0.1; 0.1; -0.3; -0.0; -1.1 | — |
| SECONDARY Percentage of Participants With Emergence of Mania at Week 24 or Week 48 |
0; 0; 0 | — |
| SECONDARY Percentage of Participants With High Suicidality at Week 24 or Week 48 |
3.6; 0; 0 | — |
| SECONDARY Percentage of Participants With Extra-Pyramidal Symptoms (EPS) at Week 24 or Week 48 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Hemoglobin (HbA1c) at Week 24 or Week 48 Endpoint |
-0.016; 0.036; 0.180 | — |
| SECONDARY Change From Baseline in Prolactin at Week 24 or Week 48 Endpoint |
-1.669; -0.388; 3.383 | — |
| SECONDARY Change From Baseline to in QTcF at Week 24 or Week 48 Endpoint |
-1.7; -8.5; -3.4 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must be aged 18 to less than 75 years.
- Each patient must be reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and must understand the nature of the study and have provided informed consent.
- All female patients must test negative for pregnancy.
- Females of breast-feeding potential must agree not to breastfeed an infant during the study and for 1 month following the last dose of study drug.
- Male patients who are not surgically sterilized must agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.
- Patients must fulfill the diagnostic criteria for bipolar I disorder, most recent episode depressed, as defined in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR).
- Patients must have experienced, in the opinion of the investigator, at least one previous manic or mixed episode, as defined in the DSM-IV-TR.
- Patients must have a current Young Mania Rating Scale (YMRS) Total score =<8.
Exclusion Criteria
- Is investigator site personnel directly affiliated with this study or their immediate families.
- Is a Lilly employee.
- Has previously completed or withdrawn from this study or any other study investigating olanzapine.
- Is pregnant or nursing.
- Has a serious, unstable illness such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months.
Data sourced from ClinicalTrials.gov (NCT00618748). 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.