Phase 3
N=524
Olanzapine Pamoate Depot Versus Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00320489 ↗Enrolled (actual)
524
Serious AEs
11.3%
Results posted
Oct 2010
Primary outcome: Primary: Median Time to Discontinuation for Any Reason (Excluding Sponsor Decision) — 644.50; 677.50 Days — p=0.612
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- olanzapine (Drug); olanzapine pamoate depot (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Time to Discontinuation for Any Reason (Excluding Sponsor Decision) |
644.50; 677.50 | 0.612 |
| SECONDARY Change From Baseline in Heinrich-Carpenter Quality of Life in Schizophrenia Scale (QLS) Total Score at 104 Weeks |
60.09; 57.73; 8.15; 7.24 | 0.649 |
| SECONDARY Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores |
42.12; 40.56; 4.87; 4.52; 47.80; 47.91 | 0.744 |
| SECONDARY Change From Baseline in Overall Health Status Assessment Using the EuroQol: 5 Dimensions Questionnaire (EQ-5D) at 104 Weeks |
66.51; 72.18; 0.07; 0.09 | 0.465 |
| SECONDARY Change From Baseline in Burden Assessment Scale (BAS) Total Score at 104 Weeks |
20.06; 20.90; -5.02; -4.14 | 0.581 |
| SECONDARY Resource Utilization: Number of Outpatient Physician Visits During the Study |
0.32; 0.65 | — |
| SECONDARY Resource Utilization: Days of Unpaid Care, Days of Workdays Missed, Days of Paid Care Per Week During the Study |
1.68; 1.40; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Number of Hospitalization Days |
0.43; 1.80 | 0.020 sig |
| SECONDARY Change From Baseline in Scale to Assess Unawareness of Mental Disorder (SUMD) Total Score at 104 Weeks |
11.12; 10.73; -0.72; -0.50; 8.81; 8.52 | 0.583 |
| SECONDARY Change From Baseline in Working Alliance Inventory (WAI) Total Score at 104 Weeks |
63.83; 63.21; -0.92; -0.07 | 0.371 |
| SECONDARY Change From Baseline in Schizophrenia Objective Functioning Instrument (SOFI) Global Score at 104 Weeks |
60.68; 60.47; 3.92; 3.26 | 0.681 |
| SECONDARY Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at 104 Weeks (All Items) |
4.20; 3.96; 3.68; 3.83; 1.91; 1.99 | 0.60 |
| SECONDARY Patient Attitude Toward Treatment Using the Drug Attitude Inventory (DAI) Scale Total Score at 104 Weeks |
7.44; 7.47 | 0.854 |
| SECONDARY Number of Participants With All-Cause Discontinuations (Excluding Sponsor Decision) |
142; 133 | 0.600 |
| SECONDARY Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Scores at 104 Weeks |
-0.36; -0.27 | 0.282 |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total and Subscale Scores at 104 Weeks |
-0.82; -1.14; -0.48; -0.42; -0.20; -0.41 | 0.834 |
| SECONDARY Median Time to Relapse |
539.00; 623.50 | 0.585 |
| SECONDARY Number of Participants Experiencing Relapse |
53; 48 | 0.659 |
| SECONDARY Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score at 104 Weeks |
-0.96; -0.91 | 0.952 |
| SECONDARY Resource Utilization: Number of Outpatient Surgeries During the Study, 24 Months After Randomization |
0.00; 0.04 | — |
| SECONDARY Change From Baseline in Weight at 104 Weeks |
81.56; 79.84; 2.04; 2.18 | 0.777 |
| SECONDARY Participants With Potentially Clinically Significant (PCS) Weight Gain at 104 Weeks |
106; 97 | 0.530 |
| SECONDARY Participants With Normal to High Fasting Glucose, Fasting Total Cholesterol, and Fasting Triglycerides |
25; 17; 12; 14; 48; 44 | 0.258 |
| SECONDARY Participants With Treatment-Emergent Abnormal High Prolactin at 104 Weeks |
12; 12 | 0.835 |
| SECONDARY Participants With Treatment-Emergent High Alanine Transaminase (ALT), Aspartate Transaminase (AST), and Total Bilirubin |
11; 12; 3; 4; 0; 2 | 0.834 |
| SECONDARY Participants Discontinuing Because of an Adverse Event (AE) or Death |
26; 27 | 0.885 |
Summary
To compare the health outcome of patients with schizophrenia, who are at risk for relapse, when treated with a long acting injection form of olanzapine versus treatment with oral olanzapine.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of schizophrenia
- Must be an outpatient (not requiring hospitalization) now and for at least the past 8 weeks.
- Disease symptoms must meet a certain range as assessed by the clinician.
- Patient has experienced at least two episodes of clinical worsening of their condition. This could mean admission to a hospital or an emergency room visit. This could mean that a new medication was added, medication dose was increased, or medication was switched in order to better control symptoms of the condition.
- The patient must have an unsatisfactory response to their current medication or be experiencing negative effects of their current medication or not always take their current medication so that a change in current medication is desired.
Exclusion Criteria
- Patients who are actively suicidal.
- Patients who are pregnant or nursing.
- Patients who have stopped past treatment with olanzapine because of adverse events, are treatment resistant or allergic to olanzapine, or have a condition which would prevent use of a long acting form of olanzapine.
- Patients with uncorrected narrow-angle glaucoma, seizures, uncontrolled diabetes, certain diseases of the liver, uncontrolled thyroid condition or other serious or unstable illness.
- Patients with Parkinson's disease, psychosis related to dementia or other related disorders.
Data sourced from ClinicalTrials.gov (NCT00320489). 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.