Trial Outcomes & Findings for Safety and Efficacy of Olanzapine in the Long-term Treatment for Bipolar I Disorder, Depressed (NCT NCT00618748)
NCT ID: NCT00618748
Last Updated: 2011-07-27
Results Overview
An adverse event (AE) is an untoward medical event associated with the use of the study drug or study procedure, whether or not it is considered related to the study drug or study procedure. Results presented are the percentage of participants who experienced an adverse event that resulted in the discontinuation of the study.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
101 participants
Primary outcome timeframe
Baseline through 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
Results posted on
2011-07-27
Participant Flow
Participant milestones
| Measure |
Pre-Olanzapine
Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
Pre-Placebo
Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
New Olanzapine
Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
56
|
25
|
20
|
|
Overall Study
COMPLETED
|
45
|
20
|
6
|
|
Overall Study
NOT COMPLETED
|
11
|
5
|
14
|
Reasons for withdrawal
| Measure |
Pre-Olanzapine
Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
Pre-Placebo
Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
New Olanzapine
Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
3
|
8
|
|
Overall Study
Physician Decision
|
3
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
5
|
Baseline Characteristics
Safety and Efficacy of Olanzapine in the Long-term Treatment for Bipolar I Disorder, Depressed
Baseline characteristics by cohort
| Measure |
Pre-Olanzapine
n=56 Participants
Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
Pre-Placebo
n=25 Participants
Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
New Olanzapine
n=20 Participants
Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
39.31 years
STANDARD_DEVIATION 10.48 • n=93 Participants
|
37.53 years
STANDARD_DEVIATION 7.64 • n=4 Participants
|
39.13 years
STANDARD_DEVIATION 9.56 • n=27 Participants
|
38.84 years
STANDARD_DEVIATION 9.61 • n=483 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
61 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
40 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
56 participants
n=93 Participants
|
25 participants
n=4 Participants
|
20 participants
n=27 Participants
|
101 participants
n=483 Participants
|
|
Region of Enrollment
Japan
|
56 participants
n=93 Participants
|
25 participants
n=4 Participants
|
20 participants
n=27 Participants
|
101 participants
n=483 Participants
|
|
Montgomery- Asberg Depression Rating Scale (MADRS) Total Score
|
8.05 units on a scale
STANDARD_DEVIATION 7.50 • n=93 Participants
|
9.72 units on a scale
STANDARD_DEVIATION 6.48 • n=4 Participants
|
16.45 units on a scale
STANDARD_DEVIATION 9.03 • n=27 Participants
|
10.13 units on a scale
STANDARD_DEVIATION 8.18 • n=483 Participants
|
|
Young Mania Rating Scale (YMRS) Total Score
|
0.38 units on a scale
STANDARD_DEVIATION 1.10 • n=93 Participants
|
0.40 units on a scale
STANDARD_DEVIATION 0.76 • n=4 Participants
|
0.45 units on a scale
STANDARD_DEVIATION 0.83 • n=27 Participants
|
0.40 units on a scale
STANDARD_DEVIATION 0.97 • n=483 Participants
|
|
Clinical Global Improvement- Bipolar (CGI-BP) - Mania
|
1.09 units on a scale
STANDARD_DEVIATION 0.35 • n=93 Participants
|
1.00 units on a scale
STANDARD_DEVIATION 0.00 • n=4 Participants
|
1.00 units on a scale
STANDARD_DEVIATION 0.00 • n=27 Participants
|
1.05 units on a scale
STANDARD_DEVIATION 0.26 • n=483 Participants
|
|
CGI-BP - Depression
|
2.23 units on a scale
STANDARD_DEVIATION 0.95 • n=93 Participants
|
2.48 units on a scale
STANDARD_DEVIATION 0.82 • n=4 Participants
|
3.55 units on a scale
STANDARD_DEVIATION 1.15 • n=27 Participants
|
2.55 units on a scale
STANDARD_DEVIATION 1.08 • n=483 Participants
|
|
CGI-BP - Overall
|
2.20 units on a scale
STANDARD_DEVIATION 0.92 • n=93 Participants
|
2.40 units on a scale
STANDARD_DEVIATION 0.82 • n=4 Participants
|
3.25 units on a scale
STANDARD_DEVIATION 1.02 • n=27 Participants
|
2.46 units on a scale
STANDARD_DEVIATION 1.00 • n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline through 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)Population: All randomized Participants.
An adverse event (AE) is an untoward medical event associated with the use of the study drug or study procedure, whether or not it is considered related to the study drug or study procedure. Results presented are the percentage of participants who experienced an adverse event that resulted in the discontinuation of the study.
Outcome measures
| Measure |
Pre-Olanzapine
n=56 Participants
Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
Pre-Placebo
n=25 Participants
Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
New Olanzapine
n=20 Participants
Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events Leading to Discontinuation
|
7.1 percentage of participants
|
12.0 percentage of participants
|
40.0 percentage of participants
|
SECONDARY outcome
Timeframe: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)Population: Participants with non-missing baseline value and the specified visit result.
Outcome measures
| Measure |
Pre-Olanzapine
n=56 Participants
Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
Pre-Placebo
n=25 Participants
Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
New Olanzapine
n=20 Participants
Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
|
|---|---|---|---|
|
Change From Baseline in Glucose and Lipid Panel at Week 24 or Week 48 Endpoint
Glucose, Fasting
|
0.03 millimole/Liter
Standard Deviation 0.47
|
0.37 millimole/Liter
Standard Deviation 0.55
|
0.68 millimole/Liter
Standard Deviation 1.31
|
|
Change From Baseline in Glucose and Lipid Panel at Week 24 or Week 48 Endpoint
Cholesterol
|
0.033 millimole/Liter
Standard Deviation 0.699
|
0.040 millimole/Liter
Standard Deviation 0.716
|
0.086 millimole/Liter
Standard Deviation 1.031
|
|
Change From Baseline in Glucose and Lipid Panel at Week 24 or Week 48 Endpoint
Low-density lipoprotein ( LDL) Cholesterol
|
0.141 millimole/Liter
Standard Deviation 0.676
|
-0.034 millimole/Liter
Standard Deviation 0.731
|
0.008 millimole/Liter
Standard Deviation 0.855
|
|
Change From Baseline in Glucose and Lipid Panel at Week 24 or Week 48 Endpoint
High-density lipoprotein ( HDL) Cholesterol
|
-0.036 millimole/Liter
Standard Deviation 0.221
|
-0.046 millimole/Liter
Standard Deviation 0.212
|
-0.074 millimole/Liter
Standard Deviation 0.239
|
|
Change From Baseline in Glucose and Lipid Panel at Week 24 or Week 48 Endpoint
Triglycerides
|
-0.108 millimole/Liter
Standard Deviation 0.543
|
0.485 millimole/Liter
Standard Deviation 1.415
|
0.382 millimole/Liter
Standard Deviation 1.270
|
SECONDARY outcome
Timeframe: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)Population: Participants with non-missing baseline value and the specified visit result.
Outcome measures
| Measure |
Pre-Olanzapine
n=56 Participants
Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
Pre-Placebo
n=25 Participants
Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
New Olanzapine
n=20 Participants
Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
|
|---|---|---|---|
|
Change From Baseline in Weight at Week 24 or Week 48 Endpoint
|
0.29 kilograms
Standard Deviation 2.79
|
0.92 kilograms
Standard Deviation 3.02
|
5.36 kilograms
Standard Deviation 4.34
|
SECONDARY outcome
Timeframe: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)Population: Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Outcome measures
| Measure |
Pre-Olanzapine
n=56 Participants
Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
Pre-Placebo
n=25 Participants
Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
New Olanzapine
n=20 Participants
Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
|
|---|---|---|---|
|
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 24 or Week 48 Endpoint
|
-0.2 units on a scale
Standard Deviation 8.3
|
-0.4 units on a scale
Standard Deviation 6.5
|
-5.8 units on a scale
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)Population: Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.
Outcome measures
| Measure |
Pre-Olanzapine
n=56 Participants
Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
Pre-Placebo
n=25 Participants
Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
New Olanzapine
n=20 Participants
Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
|
|---|---|---|---|
|
Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 24 or Week 48 Endpoint
|
0.4 units on a scale
Standard Deviation 1.5
|
-0.2 units on a scale
Standard Deviation 1.0
|
-0.1 units on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)Population: Participants with non-missing baseline value and at least one non-missing post baseline value, last observation carried forward (LOCF).
CGI-BP is a measure of illness severity especially adapted for bipolar illness. It allows rating of mania, depression, and overall illness. The scores for mania, depression, and overall illness each range from 1 (normal, not ill) to 7 (very seriously ill).
Outcome measures
| Measure |
Pre-Olanzapine
n=56 Participants
Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
Pre-Placebo
n=25 Participants
Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
New Olanzapine
n=20 Participants
Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
|
|---|---|---|---|
|
Change From Baseline in Clinical Global Improvement- Bipolar (CGI-BP) at Week 24 or Week 48 Endpoint
CGI-BP Mania
|
-0.1 units on a scale
Standard Deviation 0.4
|
0.1 units on a scale
Standard Deviation 0.3
|
0.1 units on a scale
Standard Deviation 0.2
|
|
Change From Baseline in Clinical Global Improvement- Bipolar (CGI-BP) at Week 24 or Week 48 Endpoint
CGI-BP Depression
|
-0.3 units on a scale
Standard Deviation 0.9
|
-0.0 units on a scale
Standard Deviation 0.9
|
-1.1 units on a scale
Standard Deviation 1.3
|
|
Change From Baseline in Clinical Global Improvement- Bipolar (CGI-BP) at Week 24 or Week 48 Endpoint
CGI-BP Overall Bipolar Illness
|
-0.3 units on a scale
Standard Deviation 1.0
|
-0.1 units on a scale
Standard Deviation 0.7
|
-0.9 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)Population: All Randomized participants.
Emergence of mania is defined as first occurrence of score of \>=15 in the YMRS total score in the post-baseline period of Acute Phase. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.
Outcome measures
| Measure |
Pre-Olanzapine
n=56 Participants
Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
Pre-Placebo
n=25 Participants
Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
New Olanzapine
n=20 Participants
Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Emergence of Mania at Week 24 or Week 48
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)Population: Participants with non-missing baseline value and the specified visit value.
The MINI module C (MINI-C) is a rating scale for severity of suicidal thoughts and behaviors. The MINI-C is composed of 12 Yes/No questions with variable scores assigned to each question. The scale ranges from 0 to 52 with higher scores indicating a greater presence of suicidal thoughts and/or behaviors. Based upon scores, suicidality is defined as Low (1-8), Medium (9-16), and High (\>=17).
Outcome measures
| Measure |
Pre-Olanzapine
n=56 Participants
Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
Pre-Placebo
n=25 Participants
Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
New Olanzapine
n=20 Participants
Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
|
|---|---|---|---|
|
Percentage of Participants With High Suicidality at Week 24 or Week 48
|
3.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)Population: Participants with a normal baseline and an endpoint result. For Parkinsonism, normal baseline is defined as a score not ≥3 on 1 item or ≥2 on 2 items. Normal baseline akathisia, dystonia and dyskinesia is defined as a score \<2.
EPS symptoms measured by DIEPSS are grouped into 4 categories: Parkinsonism, akathisia, dystonia, and dyskinesia. Severity ranges from level 0 (none, normal) to 4 (severe). A participant is deemed to have EPS at endpoint if they have an abnormal endpoint. Normal baseline Parkinsonism is defined as a score not ≥3 on 1 item or ≥2 on 2 items; abnormal endpoint is a score ≥3 on 1 item or ≥2 on 2 items, or an increase of 3 on Parkinsonism total. Normal baseline akathisia, dystonia and dyskinesia is defined as a score \<2; abnormal endpoint is a score ≥2 or an increase ≥2 from that baseline score.
Outcome measures
| Measure |
Pre-Olanzapine
n=56 Participants
Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
Pre-Placebo
n=25 Participants
Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
New Olanzapine
n=20 Participants
Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Extra-Pyramidal Symptoms (EPS) at Week 24 or Week 48
Dyskinesia
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Extra-Pyramidal Symptoms (EPS) at Week 24 or Week 48
Dystonia
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Extra-Pyramidal Symptoms (EPS) at Week 24 or Week 48
Parkinsonism
|
3.6 percentage of participants
|
0 percentage of participants
|
5.0 percentage of participants
|
|
Percentage of Participants With Extra-Pyramidal Symptoms (EPS) at Week 24 or Week 48
Akathisia
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)Population: Participants with non-missing baseline value and the specified visit result.
HbA1c is a test that measures the amount of glycated hemoglobin in the blood over prolonged periods of time.
Outcome measures
| Measure |
Pre-Olanzapine
n=56 Participants
Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
Pre-Placebo
n=25 Participants
Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
New Olanzapine
n=20 Participants
Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
|
|---|---|---|---|
|
Change From Baseline in Hemoglobin (HbA1c) at Week 24 or Week 48 Endpoint
|
-0.016 percentage of glycated hemoglobin
Standard Deviation 0.259
|
0.036 percentage of glycated hemoglobin
Standard Deviation 0.243
|
0.180 percentage of glycated hemoglobin
Standard Deviation 0.282
|
SECONDARY outcome
Timeframe: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)Population: Participants with non-missing baseline value and the specified visit result.
Outcome measures
| Measure |
Pre-Olanzapine
n=56 Participants
Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
Pre-Placebo
n=25 Participants
Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
New Olanzapine
n=20 Participants
Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
|
|---|---|---|---|
|
Change From Baseline in Prolactin at Week 24 or Week 48 Endpoint
|
-1.669 microgram/Liter
Standard Deviation 10.498
|
-0.388 microgram/Liter
Standard Deviation 14.179
|
3.383 microgram/Liter
Standard Deviation 18.731
|
SECONDARY outcome
Timeframe: baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)Population: Participants with non-missing baseline value and the specified visit result.
Time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, fixed correction factor (QTcF interval)
Outcome measures
| Measure |
Pre-Olanzapine
n=56 Participants
Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
Pre-Placebo
n=24 Participants
Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
New Olanzapine
n=20 Participants
Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
|
|---|---|---|---|
|
Change From Baseline to in QTcF at Week 24 or Week 48 Endpoint
|
-1.7 millisecond (msec)
Standard Deviation 16.6
|
-8.5 millisecond (msec)
Standard Deviation 13.1
|
-3.4 millisecond (msec)
Standard Deviation 13.9
|
Adverse Events
Pre-Olanzapine
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
Pre-Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
New Olanzapine
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pre-Olanzapine
n=56 participants at risk
Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
Pre-Placebo
n=25 participants at risk
Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
New Olanzapine
n=20 participants at risk
Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Psychiatric disorders
Depressive symptom
|
1.8%
1/56 • Number of events 1
|
0.00%
0/25
|
0.00%
0/20
|
Other adverse events
| Measure |
Pre-Olanzapine
n=56 participants at risk
Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
Pre-Placebo
n=25 participants at risk
Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
|
New Olanzapine
n=20 participants at risk
Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/56
|
4.0%
1/25 • Number of events 1
|
0.00%
0/20
|
|
Ear and labyrinth disorders
Inner ear disorder
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Endocrine disorders
Hyperprolactinaemia
|
5.4%
3/56 • Number of events 5
|
0.00%
0/25
|
0.00%
0/20
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
1/56 • Number of events 1
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
5.4%
3/56 • Number of events 3
|
0.00%
0/25
|
5.0%
1/20 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Fatigue
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Irritability
|
0.00%
0/56
|
0.00%
0/25
|
10.0%
2/20 • Number of events 2
|
|
General disorders
Oedema peripheral
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Thirst
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/56
|
8.0%
2/25 • Number of events 2
|
0.00%
0/20
|
|
Infections and infestations
Empyema
|
0.00%
0/56
|
4.0%
1/25 • Number of events 1
|
0.00%
0/20
|
|
Infections and infestations
Influenza
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
7/56 • Number of events 9
|
4.0%
1/25 • Number of events 1
|
15.0%
3/20 • Number of events 3
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
1.8%
1/56 • Number of events 1
|
0.00%
0/25
|
20.0%
4/20 • Number of events 5
|
|
Investigations
Aspartate aminotransferase increased
|
1.8%
1/56 • Number of events 1
|
0.00%
0/25
|
10.0%
2/20 • Number of events 2
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/56
|
4.0%
1/25 • Number of events 1
|
20.0%
4/20 • Number of events 5
|
|
Investigations
Blood creatinine increased
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Blood glucose increased
|
0.00%
0/56
|
4.0%
1/25 • Number of events 1
|
0.00%
0/20
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/56
|
4.0%
1/25 • Number of events 1
|
0.00%
0/20
|
|
Investigations
Blood pressure increased
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Blood prolactin increased
|
7.1%
4/56 • Number of events 4
|
4.0%
1/25 • Number of events 1
|
0.00%
0/20
|
|
Investigations
Blood triglycerides decreased
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/56
|
8.0%
2/25 • Number of events 2
|
10.0%
2/20 • Number of events 2
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Glucose urine present
|
1.8%
1/56 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
0.00%
0/20
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/56
|
4.0%
1/25 • Number of events 1
|
0.00%
0/20
|
|
Investigations
High density lipoprotein increased
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Liver function test abnormal
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
1.8%
1/56 • Number of events 1
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Investigations
Neutrophil count increased
|
0.00%
0/56
|
4.0%
1/25 • Number of events 1
|
0.00%
0/20
|
|
Investigations
Protein urine present
|
1.8%
1/56 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
0.00%
0/20
|
|
Investigations
Urine ketone body present
|
1.8%
1/56 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
0.00%
0/20
|
|
Investigations
Weight increased
|
5.4%
3/56 • Number of events 3
|
4.0%
1/25 • Number of events 1
|
70.0%
14/20 • Number of events 15
|
|
Investigations
White blood cell count decreased
|
3.6%
2/56 • Number of events 2
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Investigations
White blood cell count increased
|
0.00%
0/56
|
4.0%
1/25 • Number of events 1
|
0.00%
0/20
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.8%
1/56 • Number of events 1
|
0.00%
0/25
|
15.0%
3/20 • Number of events 3
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
1.8%
1/56 • Number of events 1
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/56
|
0.00%
0/25
|
45.0%
9/20 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.6%
2/56 • Number of events 2
|
0.00%
0/25
|
10.0%
2/20 • Number of events 2
|
|
Nervous system disorders
Akathisia
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
1.8%
1/56 • Number of events 1
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Dystonia
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Headache
|
7.1%
4/56 • Number of events 4
|
12.0%
3/25 • Number of events 3
|
10.0%
2/20 • Number of events 2
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
3.6%
2/56 • Number of events 2
|
0.00%
0/25
|
25.0%
5/20 • Number of events 6
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Psychiatric disorders
Apathy
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
1.8%
1/56 • Number of events 1
|
0.00%
0/25
|
10.0%
2/20 • Number of events 2
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.8%
1/56 • Number of events 1
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/56
|
4.0%
1/25 • Number of events 1
|
0.00%
0/20
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/56
|
0.00%
0/25
|
5.0%
1/20 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60