Trial Outcomes & Findings for Validation of Multidimensional Assessment of THYmic States (MATHYS): A Study in a Population of Bipolar Patients Treated With Olanzapine (NCT NCT00259272)
NCT ID: NCT00259272
Last Updated: 2009-06-24
Results Overview
A visual analogic scale consisting of 20 items. Item scores vary from 0 (inhibition of the state evaluated by the item) to 10 (excitation for the evaluated state), except for items 5 to 10 and 17 and 18 which are inversed and are consequently to be reversed before the analysis. Total score is sum of the 20 items and can vary from 0 to 200.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
141 participants
Primary outcome timeframe
Baseline, 6 Weeks, 24 weeks
Results posted on
2009-06-24
Participant Flow
All participants received olanzapine and were grouped according to their most recent type of episode.
Participant milestones
| Measure |
Manic Episode
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Hypomanic Episode
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
|
Mixed Episode
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Depressive Episode
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
36
|
31
|
26
|
48
|
|
Overall Study
COMPLETED
|
21
|
24
|
21
|
27
|
|
Overall Study
NOT COMPLETED
|
15
|
7
|
5
|
21
|
Reasons for withdrawal
| Measure |
Manic Episode
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Hypomanic Episode
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
|
Mixed Episode
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Depressive Episode
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
0
|
3
|
|
Overall Study
Lack of Efficacy
|
5
|
1
|
2
|
6
|
|
Overall Study
Physician Decision
|
1
|
2
|
1
|
3
|
|
Overall Study
Protocol Violation
|
2
|
0
|
0
|
1
|
|
Overall Study
Sponsor Decision
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
2
|
7
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
1
|
Baseline Characteristics
Validation of Multidimensional Assessment of THYmic States (MATHYS): A Study in a Population of Bipolar Patients Treated With Olanzapine
Baseline characteristics by cohort
| Measure |
Manic Episode
n=36 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Hypomanic Episode
n=31 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
|
Mixed Episode
n=26 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Depressive Episode
n=48 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
46.39 years
STANDARD_DEVIATION 15.32 • n=5 Participants
|
45.81 years
STANDARD_DEVIATION 11.68 • n=7 Participants
|
46.62 years
STANDARD_DEVIATION 12.87 • n=5 Participants
|
44.35 years
STANDARD_DEVIATION 11.98 • n=4 Participants
|
45.61 years
STANDARD_DEVIATION 12.91 • n=21 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Region of Enrollment
France
|
36 participants
n=5 Participants
|
31 participants
n=7 Participants
|
26 participants
n=5 Participants
|
48 participants
n=4 Participants
|
141 participants
n=21 Participants
|
|
Diagnostic Summary
Bipolar Disorder I
|
36 participants
n=5 Participants
|
14 participants
n=7 Participants
|
26 participants
n=5 Participants
|
31 participants
n=4 Participants
|
107 participants
n=21 Participants
|
|
Diagnostic Summary
Bipolar Disorder II - Hypomanic
|
0 participants
n=5 Participants
|
17 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
18 participants
n=21 Participants
|
|
Diagnostic Summary
Bipolar Disorder II - Depressed
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
17 participants
n=4 Participants
|
18 participants
n=21 Participants
|
|
Number of Lifetime Suicide Attempts
Missing Data
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
8 participants
n=21 Participants
|
|
Number of Lifetime Suicide Attempts
0
|
24 participants
n=5 Participants
|
23 participants
n=7 Participants
|
15 participants
n=5 Participants
|
28 participants
n=4 Participants
|
90 participants
n=21 Participants
|
|
Number of Lifetime Suicide Attempts
1
|
8 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
5 participants
n=4 Participants
|
22 participants
n=21 Participants
|
|
Number of Lifetime Suicide Attempts
2
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
8 participants
n=4 Participants
|
13 participants
n=21 Participants
|
|
Number of Lifetime Suicide Attempts
4
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Number of Lifetime Suicide Attempts
5
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Number of Lifetime Suicide Attempts
6
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Number of Lifetime Suicide Attempts
10
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Participants with at Least One Episode of Depression
Missing Data
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Participants with at Least One Episode of Depression
No
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
0 participants
n=4 Participants
|
12 participants
n=21 Participants
|
|
Participants with at Least One Episode of Depression
Yes
|
30 participants
n=5 Participants
|
29 participants
n=7 Participants
|
21 participants
n=5 Participants
|
48 participants
n=4 Participants
|
128 participants
n=21 Participants
|
|
Participants with at Least One Episode of Hypomania
Missing Data
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Participants with at Least One Episode of Hypomania
No
|
30 participants
n=5 Participants
|
1 participants
n=7 Participants
|
14 participants
n=5 Participants
|
25 participants
n=4 Participants
|
70 participants
n=21 Participants
|
|
Participants with at Least One Episode of Hypomania
Yes
|
4 participants
n=5 Participants
|
30 participants
n=7 Participants
|
9 participants
n=5 Participants
|
22 participants
n=4 Participants
|
65 participants
n=21 Participants
|
|
Participants with at Least One Episode of Mania
Missing Data
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Participants with at Least One Episode of Mania
No
|
0 participants
n=5 Participants
|
14 participants
n=7 Participants
|
11 participants
n=5 Participants
|
23 participants
n=4 Participants
|
48 participants
n=21 Participants
|
|
Participants with at Least One Episode of Mania
Yes
|
36 participants
n=5 Participants
|
14 participants
n=7 Participants
|
14 participants
n=5 Participants
|
25 participants
n=4 Participants
|
89 participants
n=21 Participants
|
|
Participants with at Least One Episode of Mixed Episode
Missing Data
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
7 participants
n=21 Participants
|
|
Participants with at Least One Episode of Mixed Episode
No
|
27 participants
n=5 Participants
|
25 participants
n=7 Participants
|
3 participants
n=5 Participants
|
32 participants
n=4 Participants
|
87 participants
n=21 Participants
|
|
Participants with at Least One Episode of Mixed Episode
Yes
|
8 participants
n=5 Participants
|
3 participants
n=7 Participants
|
22 participants
n=5 Participants
|
14 participants
n=4 Participants
|
47 participants
n=21 Participants
|
|
Patient Status
Inpatient
|
26 participants
n=5 Participants
|
12 participants
n=7 Participants
|
10 participants
n=5 Participants
|
24 participants
n=4 Participants
|
72 participants
n=21 Participants
|
|
Patient Status
Outpatient
|
10 participants
n=5 Participants
|
19 participants
n=7 Participants
|
16 participants
n=5 Participants
|
24 participants
n=4 Participants
|
69 participants
n=21 Participants
|
|
Previous Central Nervous System Treatment
Yes
|
34 participants
n=5 Participants
|
30 participants
n=7 Participants
|
26 participants
n=5 Participants
|
46 participants
n=4 Participants
|
136 participants
n=21 Participants
|
|
Previous Central Nervous System Treatment
No
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Suicide Ideation
0: Absent
|
35 participants
n=5 Participants
|
29 participants
n=7 Participants
|
15 participants
n=5 Participants
|
26 participants
n=4 Participants
|
105 participants
n=21 Participants
|
|
Suicide Ideation
1: Feels Life Not Worth Living
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
12 participants
n=4 Participants
|
22 participants
n=21 Participants
|
|
Suicide Ideation
2:Wishes He Were Dead or Thoughts of Death to Self
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
10 participants
n=4 Participants
|
14 participants
n=21 Participants
|
|
Suicide Ideation
3: Suicide Ideas or Gestures
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Suicide Ideation
4: Attempts Suicide
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Thymic Reactivity - Investigator-Based Assessment
Neither
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
3 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Thymic Reactivity - Investigator-Based Assessment
Thymic Hyper-Reactivity
|
34 participants
n=5 Participants
|
28 participants
n=7 Participants
|
20 participants
n=5 Participants
|
19 participants
n=4 Participants
|
101 participants
n=21 Participants
|
|
Thymic Reactivity - Investigator-Based Assessment
Thymic Hypo-Reactivity
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
26 participants
n=4 Participants
|
30 participants
n=21 Participants
|
|
Age at Time of Onset of First Episode
|
30.57 years
STANDARD_DEVIATION 13.94 • n=5 Participants
|
34.00 years
STANDARD_DEVIATION 13.75 • n=7 Participants
|
27.36 years
STANDARD_DEVIATION 10.78 • n=5 Participants
|
29.19 years
STANDARD_DEVIATION 10.41 • n=4 Participants
|
30.29 years
STANDARD_DEVIATION 12.31 • n=21 Participants
|
|
Body Mass Index
|
24.80 kilogram per meter squared
STANDARD_DEVIATION 4.53 • n=5 Participants
|
24.73 kilogram per meter squared
STANDARD_DEVIATION 4.98 • n=7 Participants
|
26.86 kilogram per meter squared
STANDARD_DEVIATION 7.75 • n=5 Participants
|
24.54 kilogram per meter squared
STANDARD_DEVIATION 3.70 • n=4 Participants
|
25.09 kilogram per meter squared
STANDARD_DEVIATION 5.18 • n=21 Participants
|
|
Duration of Current Episode
|
0.99 months
STANDARD_DEVIATION 1.51 • n=5 Participants
|
1.95 months
STANDARD_DEVIATION 3.22 • n=7 Participants
|
1.71 months
STANDARD_DEVIATION 1.56 • n=5 Participants
|
1.51 months
STANDARD_DEVIATION 1.49 • n=4 Participants
|
1.53 months
STANDARD_DEVIATION 2.03 • n=21 Participants
|
|
Duration of Illness
|
16.86 years
STANDARD_DEVIATION 13.93 • n=5 Participants
|
12.45 years
STANDARD_DEVIATION 9.52 • n=7 Participants
|
19.28 years
STANDARD_DEVIATION 14.54 • n=5 Participants
|
15.70 years
STANDARD_DEVIATION 11.59 • n=4 Participants
|
15.91 years
STANDARD_DEVIATION 12.46 • n=21 Participants
|
|
Weight
|
68.83 kilograms
STANDARD_DEVIATION 12.34 • n=5 Participants
|
69.89 kilograms
STANDARD_DEVIATION 14.71 • n=7 Participants
|
74.42 kilograms
STANDARD_DEVIATION 20.00 • n=5 Participants
|
70.85 kilograms
STANDARD_DEVIATION 14.41 • n=4 Participants
|
70.78 kilograms
STANDARD_DEVIATION 15.15 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 Weeks, 24 weeksPopulation: Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.
A visual analogic scale consisting of 20 items. Item scores vary from 0 (inhibition of the state evaluated by the item) to 10 (excitation for the evaluated state), except for items 5 to 10 and 17 and 18 which are inversed and are consequently to be reversed before the analysis. Total score is sum of the 20 items and can vary from 0 to 200.
Outcome measures
| Measure |
Manic Episode
n=36 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Hypomanic Episode
n=31 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
|
Mixed Episode
n=26 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Depressive Episode
n=48 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
|
|---|---|---|---|---|
|
Mean Changes From Baseline to 6 Week and 24 Week Endpoints in the Multidimensional Assessment of THYmic States Scale (MATHYS) Total Score
6 Week Endpoint (n=31, 31, 25, 44)
|
115.37 units on a scale
Standard Deviation 23.09
|
105.15 units on a scale
Standard Deviation 23.10
|
101.58 units on a scale
Standard Deviation 22.55
|
93.41 units on a scale
Standard Deviation 23.71
|
|
Mean Changes From Baseline to 6 Week and 24 Week Endpoints in the Multidimensional Assessment of THYmic States Scale (MATHYS) Total Score
Change from 6 Week Endpoint (n=30, 31, 24, 44)
|
-22.91 units on a scale
Standard Deviation 28.70
|
-31.37 units on a scale
Standard Deviation 30.46
|
-13.32 units on a scale
Standard Deviation 26.37
|
17.17 units on a scale
Standard Deviation 26.62
|
|
Mean Changes From Baseline to 6 Week and 24 Week Endpoints in the Multidimensional Assessment of THYmic States Scale (MATHYS) Total Score
Change from 24 Week Endpoint (n=34, 31, 25, 47)
|
-24.67 units on a scale
Standard Deviation 24.83
|
-33.36 units on a scale
Standard Deviation 33.61
|
-26.08 units on a scale
Standard Deviation 40.51
|
17.04 units on a scale
Standard Deviation 31.81
|
|
Mean Changes From Baseline to 6 Week and 24 Week Endpoints in the Multidimensional Assessment of THYmic States Scale (MATHYS) Total Score
Baseline (n=34, 31, 25, 48)
|
140.55 units on a scale
Standard Deviation 22.18
|
136.52 units on a scale
Standard Deviation 22.45
|
116.74 units on a scale
Standard Deviation 21.30
|
76.88 units on a scale
Standard Deviation 22.91
|
|
Mean Changes From Baseline to 6 Week and 24 Week Endpoints in the Multidimensional Assessment of THYmic States Scale (MATHYS) Total Score
24 Week Endpoint (n=35, 31, 26, 47)
|
115.15 units on a scale
Standard Deviation 24.84
|
103.16 units on a scale
Standard Deviation 23.03
|
91.56 units on a scale
Standard Deviation 25.19
|
94.58 units on a scale
Standard Deviation 27.09
|
PRIMARY outcome
Timeframe: BaselinePopulation: Matrix based on data from all 141 participants.
This analysis indicates whether the total score is correct and provides enough information, or if subscores need to be calculated. Eigen value, proportion and cumulative are statistical parameters from the Principal Component Analysis, given for each factor.
Outcome measures
| Measure |
Manic Episode
n=141 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Hypomanic Episode
n=141 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
|
Mixed Episode
n=141 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Depressive Episode
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
|
|---|---|---|---|---|
|
Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix
Factor 6
|
0.79 value
|
0.0397 value
|
0.7392 value
|
—
|
|
Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix
Factor 7
|
0.69 value
|
0.0347 value
|
0.7739 value
|
—
|
|
Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix
Factor 8
|
0.64 value
|
0.0322 value
|
0.8061 value
|
—
|
|
Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix
Factor 14
|
0.34 value
|
0.0171 value
|
0.9412 value
|
—
|
|
Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix
Factor 15
|
0.28 value
|
0.0139 value
|
0.9551 value
|
—
|
|
Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix
Factor 16
|
0.26 value
|
0.0131 value
|
0.9682 value
|
—
|
|
Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix
Factor 17
|
0.20 value
|
0.0100 value
|
0.9782 value
|
—
|
|
Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix
Factor 18
|
0.18 value
|
0.0091 value
|
0.9873 value
|
—
|
|
Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix
Factor 19
|
0.14 value
|
0.0071 value
|
0.9944 value
|
—
|
|
Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix
Factor 1
|
8.77 value
|
0.4383 value
|
0.4383 value
|
—
|
|
Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix
Factor 2
|
2.01 value
|
0.1006 value
|
0.5389 value
|
—
|
|
Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix
Factor 3
|
1.19 value
|
0.0594 value
|
0.5984 value
|
—
|
|
Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix
Factor 4
|
1.042 value
|
0.0521 value
|
0.6505 value
|
—
|
|
Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix
Factor 5
|
0.98 value
|
0.0490 value
|
0.6995 value
|
—
|
|
Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix
Factor 9
|
0.56 value
|
0.0280 value
|
0.8341 value
|
—
|
|
Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix
Factor 10
|
0.54 value
|
0.0268 value
|
0.8608 value
|
—
|
|
Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix
Factor 11
|
0.45 value
|
0.0227 value
|
0.8836 value
|
—
|
|
Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix
Factor 12
|
0.44 value
|
0.0219 value
|
0.9055 value
|
—
|
|
Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix
Factor 13
|
0.37 value
|
0.0186 value
|
0.9241 value
|
—
|
|
Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix
Factor 20
|
0.11 value
|
0.0056 value
|
1.0000 value
|
—
|
SECONDARY outcome
Timeframe: Baseline, 6 Weeks, 24 WeeksPopulation: Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.
The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (not at all depressed) to 52 (severely depressed).
Outcome measures
| Measure |
Manic Episode
n=36 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Hypomanic Episode
n=31 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
|
Mixed Episode
n=26 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Depressive Episode
n=48 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
|
|---|---|---|---|---|
|
Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton 17-Items Depression Scale (HAMD-17) Total Score
Change from 24 Week Endpoint (n=34, 30, 26, 47)
|
-1.74 units on a scale
Standard Deviation 5.02
|
-3.20 units on a scale
Standard Deviation 6.40
|
-5.50 units on a scale
Standard Deviation 6.72
|
-7.96 units on a scale
Standard Deviation 7.18
|
|
Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton 17-Items Depression Scale (HAMD-17) Total Score
Baseline (n=35, 30, 26, 48)
|
6.46 units on a scale
Standard Deviation 4.86
|
8.43 units on a scale
Standard Deviation 5.33
|
12.65 units on a scale
Standard Deviation 4.83
|
16.06 units on a scale
Standard Deviation 7.19
|
|
Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton 17-Items Depression Scale (HAMD-17) Total Score
Change from 6 Week Endpoint (n=29, 29, 25, 45)
|
-1.79 units on a scale
Standard Deviation 4.59
|
-3.10 units on a scale
Standard Deviation 4.59
|
-5.60 units on a scale
Standard Deviation 6.60
|
-8.51 units on a scale
Standard Deviation 6.22
|
SECONDARY outcome
Timeframe: Baseline, 6 Weeks, 24 WeeksPopulation: Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.
The 14-item HAMA assesses the severity of anxiety. The investigator talked to the patient about their symptoms over the previous week before the study visit. Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe. The total score of HAMA-14 may range from 0 (not present) to 56 (very severe).
Outcome measures
| Measure |
Manic Episode
n=36 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Hypomanic Episode
n=31 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
|
Mixed Episode
n=26 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Depressive Episode
n=48 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
|
|---|---|---|---|---|
|
Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton Anxiety Scale (HAMA) Total Score
Baseline (n=36, 31, 26, 48)
|
7.78 units on a scale
Standard Deviation 6.29
|
11.94 units on a scale
Standard Deviation 7.73
|
15.46 units on a scale
Standard Deviation 7.17
|
15.08 units on a scale
Standard Deviation 7.35
|
|
Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton Anxiety Scale (HAMA) Total Score
Change from 6 Week Endpoint (n=31, 31, 25, 45)
|
-2.68 units on a scale
Standard Deviation 4.85
|
-5.48 units on a scale
Standard Deviation 5.89
|
-7.32 units on a scale
Standard Deviation 6.31
|
-6.76 units on a scale
Standard Deviation 6.61
|
|
Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton Anxiety Scale (HAMA) Total Score
Change from 24 Week Endpoint (n=35, 31, 26, 47)
|
-2.26 units on a scale
Standard Deviation 4.80
|
-5.65 units on a scale
Standard Deviation 7.36
|
-7.62 units on a scale
Standard Deviation 7.87
|
-6.83 units on a scale
Standard Deviation 7.19
|
SECONDARY outcome
Timeframe: Baseline, 6 Weeks, 24 WeeksPopulation: Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.
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 |
Manic Episode
n=36 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Hypomanic Episode
n=31 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
|
Mixed Episode
n=26 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Depressive Episode
n=48 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
|
|---|---|---|---|---|
|
Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Young Mania Rating Scale (YMRS) Total Score
Baseline (n=36, 31, 25, 46)
|
24.50 units on a scale
Standard Deviation 10.34
|
17.84 units on a scale
Standard Deviation 4.88
|
12.96 units on a scale
Standard Deviation 7.69
|
2.78 units on a scale
Standard Deviation 3.64
|
|
Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Young Mania Rating Scale (YMRS) Total Score
Change from 6 Week Endpoint (n=31, 31, 24, 43)
|
-13.65 units on a scale
Standard Deviation 9.38
|
-13.13 units on a scale
Standard Deviation 6.02
|
-9.67 units on a scale
Standard Deviation 7.91
|
-0.86 units on a scale
Standard Deviation 3.54
|
|
Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Young Mania Rating Scale (YMRS) Total Score
Change from 24 Week Endpoint (n=35, 31, 25, 45)
|
-14.00 units on a scale
Standard Deviation 10.94
|
-14.45 units on a scale
Standard Deviation 7.36
|
-10.60 units on a scale
Standard Deviation 7.95
|
-0.82 units on a scale
Standard Deviation 3.24
|
SECONDARY outcome
Timeframe: baseline and 24 weeksPopulation: Safety Population. All participants having been prescribed at least one dose of study drug. Number of participants with baseline and at least one non-missing postbaseline value.
Outcome measures
| Measure |
Manic Episode
n=36 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Hypomanic Episode
n=31 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
|
Mixed Episode
n=26 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Depressive Episode
n=48 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
|
|---|---|---|---|---|
|
Mean Change From Baseline to 24 Week Endpoint in Glycaemia Levels (Glucose Fasting Levels)
Baseline (n=33, 30, 23, 47)
|
89.27 milligrams per deciliter
Standard Deviation 16.31
|
85.99 milligrams per deciliter
Standard Deviation 11.33
|
85.94 milligrams per deciliter
Standard Deviation 12.58
|
88.52 milligrams per deciliter
Standard Deviation 13.95
|
|
Mean Change From Baseline to 24 Week Endpoint in Glycaemia Levels (Glucose Fasting Levels)
Change from 24 Week Endpoint (n=26, 28, 23, 40)
|
-3.07 milligrams per deciliter
Standard Deviation 16.15
|
4.65 milligrams per deciliter
Standard Deviation 15.32
|
3.89 milligrams per deciliter
Standard Deviation 9.62
|
7.31 milligrams per deciliter
Standard Deviation 30.42
|
SECONDARY outcome
Timeframe: over 24 weeksPopulation: Safety Population. All participants having been prescribed at least one dose of study drug.
Outcome measures
| Measure |
Manic Episode
n=36 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Hypomanic Episode
n=31 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
|
Mixed Episode
n=26 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Depressive Episode
n=48 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
|
|---|---|---|---|---|
|
Increases and Decreases in Fasting Glucose Levels
At Least One Increase in Fasting Glucose (FG)
|
5 participants
|
9 participants
|
3 participants
|
10 participants
|
|
Increases and Decreases in Fasting Glucose Levels
At Least One Decrease in FG
|
4 participants
|
8 participants
|
1 participants
|
11 participants
|
|
Increases and Decreases in Fasting Glucose Levels
At Least One Increase/Decrease in FG
|
7 participants
|
10 participants
|
3 participants
|
15 participants
|
|
Increases and Decreases in Fasting Glucose Levels
Patients Who Increase and Decrease During Study
|
2 participants
|
7 participants
|
1 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Baseline and 24 WeeksPopulation: Safety Population. All participants having been prescribed at least one dose of study drug. Number of participants with baseline and at least one non-missing postbaseline value.
Baseline, change from baseline, and percent change for the following lipids are presented: Total Cholesterol (TC), High Density Lipoproteins (HDL), Low Density Lipoproteins (LDL), and Triglycerides (TG).
Outcome measures
| Measure |
Manic Episode
n=36 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Hypomanic Episode
n=31 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
|
Mixed Episode
n=26 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Depressive Episode
n=48 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
|
|---|---|---|---|---|
|
Mean Change From Baseline to 24 Week Endpoint in Lipids
LDL Baseline (n=34, 30, 23, 46)
|
112.76 milligrams per deciliter
Standard Deviation 39.81
|
112.16 milligrams per deciliter
Standard Deviation 31.37
|
129.70 milligrams per deciliter
Standard Deviation 44.64
|
128.81 milligrams per deciliter
Standard Deviation 39.26
|
|
Mean Change From Baseline to 24 Week Endpoint in Lipids
TC Baseline (n=33, 30, 24, 46)
|
182.88 milligrams per deciliter
Standard Deviation 41.88
|
191.55 milligrams per deciliter
Standard Deviation 42.49
|
210.51 milligrams per deciliter
Standard Deviation 50.78
|
203.77 milligrams per deciliter
Standard Deviation 44.66
|
|
Mean Change From Baseline to 24 Week Endpoint in Lipids
Change in TC from 24 Week Endpoint (n=26,28,23,41)
|
23.64 milligrams per deciliter
Standard Deviation 33.95
|
2.26 milligrams per deciliter
Standard Deviation 27.25
|
7.03 milligrams per deciliter
Standard Deviation 30.77
|
4.41 milligrams per deciliter
Standard Deviation 50.69
|
|
Mean Change From Baseline to 24 Week Endpoint in Lipids
Percent Change in TC (n=26, 28, 23, 41)
|
14.96 milligrams per deciliter
Standard Deviation 19.57
|
3.10 milligrams per deciliter
Standard Deviation 13.83
|
4.41 milligrams per deciliter
Standard Deviation 16.97
|
4.68 milligrams per deciliter
Standard Deviation 23.67
|
|
Mean Change From Baseline to 24 Week Endpoint in Lipids
HDL Baseline (n=33, 30, 23, 46)
|
50.21 milligrams per deciliter
Standard Deviation 14.65
|
56.87 milligrams per deciliter
Standard Deviation 16.77
|
57.46 milligrams per deciliter
Standard Deviation 19.13
|
50.78 milligrams per deciliter
Standard Deviation 13.35
|
|
Mean Change From Baseline to 24 Week Endpoint in Lipids
Change in HDL from Endpoint (n=26, 28, 22, 41)
|
1.24 milligrams per deciliter
Standard Deviation 13.32
|
1.57 milligrams per deciliter
Standard Deviation 13.14
|
-0.45 milligrams per deciliter
Standard Deviation 16.27
|
3.25 milligrams per deciliter
Standard Deviation 12.72
|
|
Mean Change From Baseline to 24 Week Endpoint in Lipids
Percent Change in HDL (n=26, 28, 22, 41)
|
6.04 milligrams per deciliter
Standard Deviation 26.43
|
6.17 milligrams per deciliter
Standard Deviation 26.06
|
3.78 milligrams per deciliter
Standard Deviation 26.12
|
8.87 milligrams per deciliter
Standard Deviation 23.97
|
|
Mean Change From Baseline to 24 Week Endpoint in Lipids
Change in LDL from Endpoint (n=27, 27, 22, 41)
|
14.22 milligrams per deciliter
Standard Deviation 41.05
|
1.28 milligrams per deciliter
Standard Deviation 36.64
|
9.46 milligrams per deciliter
Standard Deviation 32.04
|
-1.19 milligrams per deciliter
Standard Deviation 42.24
|
|
Mean Change From Baseline to 24 Week Endpoint in Lipids
Percent Change in LDL (n=27, 27, 22, 41)
|
20.54 milligrams per deciliter
Standard Deviation 33.94
|
5.15 milligrams per deciliter
Standard Deviation 33.05
|
11.37 milligrams per deciliter
Standard Deviation 28.57
|
3.41 milligrams per deciliter
Standard Deviation 32.28
|
|
Mean Change From Baseline to 24 Week Endpoint in Lipids
TG Baseline (n=35, 30, 23, 46)
|
115.81 milligrams per deciliter
Standard Deviation 43.15
|
110.66 milligrams per deciliter
Standard Deviation 89.64
|
131.37 milligrams per deciliter
Standard Deviation 71.65
|
120.15 milligrams per deciliter
Standard Deviation 66.63
|
|
Mean Change From Baseline to 24 Week Endpoint in Lipids
Change in TG from 24 Week Endpoint (n=27,28,22,41)
|
8.37 milligrams per deciliter
Standard Deviation 66.50
|
25.86 milligrams per deciliter
Standard Deviation 90.32
|
-1.16 milligrams per deciliter
Standard Deviation 49.06
|
13.85 milligrams per deciliter
Standard Deviation 67.59
|
|
Mean Change From Baseline to 24 Week Endpoint in Lipids
Percent Change in TG (n=27, 28, 22, 41)
|
20.65 milligrams per deciliter
Standard Deviation 72.42
|
40.06 milligrams per deciliter
Standard Deviation 74.56
|
4.10 milligrams per deciliter
Standard Deviation 36.59
|
25.95 milligrams per deciliter
Standard Deviation 60.73
|
SECONDARY outcome
Timeframe: over 24 weeksPopulation: Safety Population. All participants having been prescribed at least one dose of study drug.
Outcome measures
| Measure |
Manic Episode
n=36 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Hypomanic Episode
n=31 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
|
Mixed Episode
n=26 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Depressive Episode
n=48 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
|
|---|---|---|---|---|
|
Increases and Decreases in Lipid Levels
At Least One Increase/Decrease for TG
|
15 participants
|
11 participants
|
8 participants
|
16 participants
|
|
Increases and Decreases in Lipid Levels
Patients Who Increase & Decrease in HDL
|
3 participants
|
3 participants
|
4 participants
|
7 participants
|
|
Increases and Decreases in Lipid Levels
≥1 Increase for Low Density Lipoprotein (LDL)
|
15 participants
|
8 participants
|
11 participants
|
17 participants
|
|
Increases and Decreases in Lipid Levels
At Least One Decrease for LDL
|
8 participants
|
7 participants
|
7 participants
|
17 participants
|
|
Increases and Decreases in Lipid Levels
At Least One Increase/Decrease for LDL
|
17 participants
|
12 participants
|
12 participants
|
25 participants
|
|
Increases and Decreases in Lipid Levels
Patients Who Increase & Decrease in LDL
|
6 participants
|
3 participants
|
6 participants
|
9 participants
|
|
Increases and Decreases in Lipid Levels
At Least One Increase for Triglycerides (TG)
|
11 participants
|
7 participants
|
6 participants
|
11 participants
|
|
Increases and Decreases in Lipid Levels
At Least One Decrease for TG
|
12 participants
|
7 participants
|
7 participants
|
13 participants
|
|
Increases and Decreases in Lipid Levels
Patients Who Increase & Decrease in TG
|
8 participants
|
3 participants
|
5 participants
|
8 participants
|
|
Increases and Decreases in Lipid Levels
At Least One Increase for Total Cholesterol (TC)
|
18 participants
|
7 participants
|
11 participants
|
20 participants
|
|
Increases and Decreases in Lipid Levels
At Least One Decrease for TC
|
11 participants
|
9 participants
|
10 participants
|
16 participants
|
|
Increases and Decreases in Lipid Levels
At Least One Increase/Decrease for TC
|
19 participants
|
12 participants
|
14 participants
|
26 participants
|
|
Increases and Decreases in Lipid Levels
Patients Who Increase & Decrease in TC
|
10 participants
|
4 participants
|
7 participants
|
10 participants
|
|
Increases and Decreases in Lipid Levels
≥1 Increase for High Density Lipoprotein (HDL)
|
8 participants
|
5 participants
|
6 participants
|
11 participants
|
|
Increases and Decreases in Lipid Levels
At Least One Decrease for HDL
|
4 participants
|
6 participants
|
5 participants
|
8 participants
|
|
Increases and Decreases in Lipid Levels
At Least One Increase/Decrease for HDL
|
9 participants
|
8 participants
|
7 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Baseline and 24 weeksPopulation: Safety Population. All participants having been prescribed at least one dose of study drug. Number of participants with baseline and at least one non-missing postbaseline value.
Outcome measures
| Measure |
Manic Episode
n=36 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Hypomanic Episode
n=31 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
|
Mixed Episode
n=26 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Depressive Episode
n=47 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
|
|---|---|---|---|---|
|
Mean Change From Baseline to 24 Week Endpoint in Weight
|
1.37 kilograms
Standard Deviation 2.98
|
1.91 kilograms
Standard Deviation 3.44
|
1.78 kilograms
Standard Deviation 4.43
|
2.15 kilograms
Standard Deviation 2.60
|
SECONDARY outcome
Timeframe: over 24 weeksPopulation: Safety Population. All participants having been prescribed at least one dose of study drug.
Weight gain at anytime more than 7%-15% or 25% of body weight compared to baseline
Outcome measures
| Measure |
Manic Episode
n=36 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Hypomanic Episode
n=31 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
|
Mixed Episode
n=26 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Depressive Episode
n=48 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
|
|---|---|---|---|---|
|
Weight Gain Compared to Baseline
Missing Data
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Weight Gain Compared to Baseline
No Significant Gain
|
30 participants
2.98
|
26 participants
3.44
|
18 participants
4.43
|
42 participants
2.60
|
|
Weight Gain Compared to Baseline
>25%
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Weight Gain Compared to Baseline
>15%
|
1 participants
|
2 participants
|
1 participants
|
0 participants
|
|
Weight Gain Compared to Baseline
>7%
|
5 participants
|
3 participants
|
7 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Subgroup of patients who gained more than 7% of body weight.
Outcome measures
| Measure |
Manic Episode
n=24 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Hypomanic Episode
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
|
Mixed Episode
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Depressive Episode
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
|
|---|---|---|---|---|
|
Wellness Interventional Program for Weight Gain Management in Patients (for Those Who Gain at Anytime More Than 7% of Body Weight, Compared to Baseline)
Advised to Consult Dietician - No
|
8 participants
|
—
|
—
|
—
|
|
Wellness Interventional Program for Weight Gain Management in Patients (for Those Who Gain at Anytime More Than 7% of Body Weight, Compared to Baseline)
Advised to Consult Dietician - Yes
|
16 participants
|
—
|
—
|
—
|
|
Wellness Interventional Program for Weight Gain Management in Patients (for Those Who Gain at Anytime More Than 7% of Body Weight, Compared to Baseline)
Performed a Wellness Program - No
|
6 participants
|
—
|
—
|
—
|
|
Wellness Interventional Program for Weight Gain Management in Patients (for Those Who Gain at Anytime More Than 7% of Body Weight, Compared to Baseline)
Performed a Wellness Program - Yes
|
10 participants
|
—
|
—
|
—
|
|
Wellness Interventional Program for Weight Gain Management in Patients (for Those Who Gain at Anytime More Than 7% of Body Weight, Compared to Baseline)
Number of Wellnes Program Consults - 1
|
5 participants
|
—
|
—
|
—
|
|
Wellness Interventional Program for Weight Gain Management in Patients (for Those Who Gain at Anytime More Than 7% of Body Weight, Compared to Baseline)
Number of Wellnes Program Consults - 2
|
2 participants
|
—
|
—
|
—
|
|
Wellness Interventional Program for Weight Gain Management in Patients (for Those Who Gain at Anytime More Than 7% of Body Weight, Compared to Baseline)
Number of Wellnes Program Consults - 3
|
3 participants
|
—
|
—
|
—
|
|
Wellness Interventional Program for Weight Gain Management in Patients (for Those Who Gain at Anytime More Than 7% of Body Weight, Compared to Baseline)
Patients Losing Weight After Consultation
|
8 participants
|
—
|
—
|
—
|
|
Wellness Interventional Program for Weight Gain Management in Patients (for Those Who Gain at Anytime More Than 7% of Body Weight, Compared to Baseline)
Patients Gaining Weight After Consultation
|
8 participants
|
—
|
—
|
—
|
|
Wellness Interventional Program for Weight Gain Management in Patients (for Those Who Gain at Anytime More Than 7% of Body Weight, Compared to Baseline)
Patients with Stable Weight After Consultation
|
0 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.
A visual analogic scale consisting of 20 items. Items scores vary from 0 (inhibition of the state evaluated by the item) to 10 (excitation for the evaluated state), except for items 5 to 10 and 17 and 18, which are inversed and are consequently to be reversed before the analysis. Total score is sum of the 20 items and can vary from 0 to 200.
Outcome measures
| Measure |
Manic Episode
n=30 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Hypomanic Episode
n=101 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
|
Mixed Episode
n=10 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Depressive Episode
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
|
|---|---|---|---|---|
|
MATHYS Total Score at Baseline - According to Thymic Reactivity Assessment
|
81.24 units on a scale
Standard Deviation 30.81
|
122.49 units on a scale
Standard Deviation 32.01
|
117.26 units on a scale
Standard Deviation 26.41
|
—
|
SECONDARY outcome
Timeframe: Baseline, 6 Weeks, 24 WeeksPopulation: Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.
The 14-item HAMA assesses the severity of anxiety. The investigator talked to the patient about their symptoms over the previous week before the study visit. Each item was scored using a 5-point scale, i.e. 0 = absent to 4 = severe. The total score of HAMA-14 may range from 0 (not present) to 56 (very severe).
Outcome measures
| Measure |
Manic Episode
n=30 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Hypomanic Episode
n=101 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
|
Mixed Episode
n=10 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Depressive Episode
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
|
|---|---|---|---|---|
|
Change From Baseline to 6 Week and 24 Week Endpoints in HAMA Total Scores - According to Thymic Reactivity Assessment
Change from 24 Week Endpoint (n=30, 99, 10)
|
-4.83 units on a scale
Standard Deviation 5.94
|
-5.65 units on a scale
Standard Deviation 7.39
|
-6.90 units on a scale
Standard Deviation 7.43
|
—
|
|
Change From Baseline to 6 Week and 24 Week Endpoints in HAMA Total Scores - According to Thymic Reactivity Assessment
Baseline (n=30, 101, 10)
|
12.87 units on a scale
Standard Deviation 7.09
|
12.63 units on a scale
Standard Deviation 7.95
|
11.40 units on a scale
Standard Deviation 7.95
|
—
|
|
Change From Baseline to 6 Week and 24 Week Endpoints in HAMA Total Scores - According to Thymic Reactivity Assessment
Change from 6 Week Endpoint (n=29, 93, 10)
|
-4.93 units on a scale
Standard Deviation 5.62
|
-5.96 units on a scale
Standard Deviation 6.56
|
-4.30 units on a scale
Standard Deviation 3.95
|
—
|
SECONDARY outcome
Timeframe: Baseline, 6 Weeks, 24 WeeksPopulation: Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.
The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (not at all depressed) to 52 (severely depressed).
Outcome measures
| Measure |
Manic Episode
n=30 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Hypomanic Episode
n=101 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
|
Mixed Episode
n=10 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Depressive Episode
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
|
|---|---|---|---|---|
|
Change From Baseline to 6 Week and 24 Week Endpoints in HAMD-17 Total Scores - According to Thymic Reactivity Assessment
Baseline (n=29, 100, 10)
|
14.48 units on a scale
Standard Deviation 7.02
|
10.64 units on a scale
Standard Deviation 6.85
|
9.50 units on a scale
Standard Deviation 7.01
|
—
|
|
Change From Baseline to 6 Week and 24 Week Endpoints in HAMD-17 Total Scores - According to Thymic Reactivity Assessment
Change from 6 Week Endpoint (n=28, 90, 10)
|
-6.61 units on a scale
Standard Deviation 5.02
|
-4.89 units on a scale
Standard Deviation 6.62
|
-4.00 units on a scale
Standard Deviation 5.12
|
—
|
|
Change From Baseline to 6 Week and 24 Week Endpoints in HAMD-17 Total Scores - According to Thymic Reactivity Assessment
Change from 24 Week Endpoint (n=28, 98, 10)
|
-6.48 units on a scale
Standard Deviation 4.32
|
-4.55 units on a scale
Standard Deviation 7.58
|
-3.80 units on a scale
Standard Deviation 4.85
|
—
|
SECONDARY outcome
Timeframe: Baseline, 6 Weeks, 24 WeeksPopulation: Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.
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 |
Manic Episode
n=30 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Hypomanic Episode
n=101 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
|
Mixed Episode
n=10 Participants
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
|
Depressive Episode
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
|
|---|---|---|---|---|
|
Change From Baseline to 6 Week and 24 Week Endpoints in YMRS Total Scores - According to Thymic Reactivity Assessment
Baseline (n=27, 101, 10)
|
4.48 units on a scale
Standard Deviation 7.99
|
16.50 units on a scale
Standard Deviation 10.65
|
10.00 units on a scale
Standard Deviation 7.24
|
—
|
|
Change From Baseline to 6 Week and 24 Week Endpoints in YMRS Total Scores - According to Thymic Reactivity Assessment
Change from 6 Week Endpoint (n=26, 93, 10)
|
-2.38 units on a scale
Standard Deviation 7.90
|
-10.45 units on a scale
Standard Deviation 8.46
|
-6.50 units on a scale
Standard Deviation 4.70
|
—
|
|
Change From Baseline to 6 Week and 24 Week Endpoints in YMRS Total Scores - According to Thymic Reactivity Assessment
Change from 24 Week Endpoint (n=27, 99, 10)
|
-1.70 units on a scale
Standard Deviation 5.19
|
-11.29 units on a scale
Standard Deviation 9.89
|
-7.60 units on a scale
Standard Deviation 5.52
|
—
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Measures were to be collected at only one site. Not enough data to analyze.
to assess emotional reactivity with the physiological measure of heart rate, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: Measures were to be collected at only one site. Not enough data to analyze.
To assess emotional reactivity with the physiological measure of skin conductance, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: Measures were to be collected at only one site. Not enough data to analyze.
To assess emotional reactivity with the physiological measure of startle reflex response by measuring the latency of the blink, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: Measures were to be collected at only one site. Not enough data to analyze.
To assess emotional reactivity with the physiological measure of startle reflex response - by measuring the amplitude of the blink, recorded as a function of slides sessions from the International Affective Picture System, in a defined subgroup of patients.
Outcome measures
Outcome data not reported
Adverse Events
Olanzapine
Serious events: 14 serious events
Other events: 53 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Olanzapine
Olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks.
|
|---|---|
|
Gastrointestinal disorders
Gastric ulcer
|
0.71%
1/141 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.71%
1/141 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.71%
1/141 • Number of events 1
|
|
Psychiatric disorders
Alcoholism
|
0.71%
1/141 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.71%
1/141 • Number of events 1
|
|
Psychiatric disorders
Bipolar I disorder
|
3.5%
5/141 • Number of events 5
|
|
Psychiatric disorders
Depression
|
2.8%
4/141 • Number of events 4
|
|
Psychiatric disorders
Suicide attempt
|
0.71%
1/141 • Number of events 1
|
|
Vascular disorders
Arteritis
|
0.71%
1/141 • Number of events 2
|
Other adverse events
| Measure |
Olanzapine
Olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks.
|
|---|---|
|
Cardiac disorders
Palpitations
|
0.71%
1/141 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.71%
1/141 • Number of events 1
|
|
Endocrine disorders
Hyperprolactinaemia
|
0.71%
1/141 • Number of events 1
|
|
Endocrine disorders
Hypothyroidism
|
0.71%
1/141 • Number of events 1
|
|
Eye disorders
Eye pruritus
|
0.71%
1/141 • Number of events 1
|
|
Eye disorders
Vision blurred
|
1.4%
2/141 • Number of events 2
|
|
Eye disorders
Visual disturbance
|
0.71%
1/141 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.71%
1/141 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
5.0%
7/141 • Number of events 7
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
2/141 • Number of events 3
|
|
Gastrointestinal disorders
Dry mouth
|
5.7%
8/141 • Number of events 8
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.71%
1/141 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.71%
1/141 • Number of events 1
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.71%
1/141 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
2/141 • Number of events 2
|
|
General disorders
Asthenia
|
2.1%
3/141 • Number of events 3
|
|
Immune system disorders
Food allergy
|
0.71%
1/141 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
0.71%
1/141 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.71%
1/141 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.71%
1/141 • Number of events 1
|
|
Investigations
Blood creatine phosphokinase increased
|
0.71%
1/141 • Number of events 1
|
|
Investigations
Blood triglycerides increased
|
0.71%
1/141 • Number of events 1
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.4%
2/141 • Number of events 2
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.71%
1/141 • Number of events 1
|
|
Investigations
Transaminases increased
|
0.71%
1/141 • Number of events 1
|
|
Investigations
Weight increased
|
2.1%
3/141 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.71%
1/141 • Number of events 1
|
|
Metabolism and nutrition disorders
Increased appetite
|
1.4%
2/141 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.71%
1/141 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.71%
1/141 • Number of events 1
|
|
Nervous system disorders
Akathisia
|
0.71%
1/141 • Number of events 1
|
|
Nervous system disorders
Cognitive disorder
|
0.71%
1/141 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
1.4%
2/141 • Number of events 2
|
|
Nervous system disorders
Dysarthria
|
0.71%
1/141 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.71%
1/141 • Number of events 1
|
|
Nervous system disorders
Hypertonia
|
0.71%
1/141 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.71%
1/141 • Number of events 1
|
|
Nervous system disorders
Restless legs syndrome
|
0.71%
1/141 • Number of events 1
|
|
Nervous system disorders
Sedation
|
0.71%
1/141 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
5.0%
7/141 • Number of events 8
|
|
Nervous system disorders
Tremor
|
5.0%
7/141 • Number of events 7
|
|
Psychiatric disorders
Agitation
|
0.71%
1/141 • Number of events 1
|
|
Psychiatric disorders
Depression
|
0.71%
1/141 • Number of events 1
|
|
Psychiatric disorders
Loss of libido
|
1.4%
2/141 • Number of events 2
|
|
Psychiatric disorders
Memory impairment
|
0.71%
1/141 • Number of events 1
|
|
Psychiatric disorders
Sleep disorder
|
0.71%
1/141 • Number of events 1
|
|
Psychiatric disorders
Suicidal ideation
|
1.4%
2/141 • Number of events 2
|
|
Psychiatric disorders
Suicide attempt
|
0.71%
1/141 • Number of events 1
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.71%
1/141 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.71%
1/141 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.71%
1/141 • Number of events 1
|
|
Vascular disorders
Arteritis
|
0.71%
1/141 • Number of events 2
|
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