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Trial record 12 of 69 for:    "Bipolar Disorder" | "Olanzapine"

Validation of Multidimensional Assessment of THYmic States (MATHYS): A Study in a Population of Bipolar Patients Treated With Olanzapine

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ClinicalTrials.gov Identifier: NCT00259272
Recruitment Status : Completed
First Posted : November 29, 2005
Results First Posted : June 24, 2009
Last Update Posted : June 24, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bipolar Disorder I or II
Intervention Drug: olanzapine
Enrollment 141
Recruitment Details  
Pre-assignment Details All participants received olanzapine and were grouped according to their most recent type of episode.
Arm/Group Title Manic Episode Hypomanic Episode Mixed Episode Depressive Episode
Hide Arm/Group Description olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg) olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
Period Title: Overall Study
Started 36 31 26 48
Completed 21 24 21 27
Not Completed 15 7 5 21
Reason Not Completed
Adverse Event             2             1             0             3
Lack of Efficacy             5             1             2             6
Physician Decision             1             2             1             3
Protocol Violation             2             0             0             1
Sponsor Decision             0             1             0             0
Withdrawal by Subject             4             2             2             7
Lost to Follow-up             1             0             0             1
Arm/Group Title Manic Episode Hypomanic Episode Mixed Episode Depressive Episode Total
Hide Arm/Group Description olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg) olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg). Total of all reporting groups
Overall Number of Baseline Participants 36 31 26 48 141
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 31 participants 26 participants 48 participants 141 participants
46.39  (15.32) 45.81  (11.68) 46.62  (12.87) 44.35  (11.98) 45.61  (12.91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 31 participants 26 participants 48 participants 141 participants
Female
19
  52.8%
21
  67.7%
15
  57.7%
25
  52.1%
80
  56.7%
Male
17
  47.2%
10
  32.3%
11
  42.3%
23
  47.9%
61
  43.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
France Number Analyzed 36 participants 31 participants 26 participants 48 participants 141 participants
36 31 26 48 141
Diagnostic Summary  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants 31 participants 26 participants 48 participants 141 participants
Bipolar Disorder I 36 14 26 31 107
Bipolar Disorder II - Hypomanic 0 17 1 0 18
Bipolar Disorder II - Depressed 0 0 1 17 18
Number of Lifetime Suicide Attempts  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants 31 participants 26 participants 48 participants 141 participants
Missing Data 2 3 1 2 8
0 24 23 15 28 90
1 8 3 6 5 22
2 2 0 3 8 13
4 0 1 0 2 3
5 0 0 0 2 2
6 0 1 0 0 1
10 0 0 1 1 2
Participants with at Least One Episode of Depression   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants 31 participants 26 participants 48 participants 141 participants
Missing Data 0 0 1 0 1
No 6 2 4 0 12
Yes 30 29 21 48 128
[1]
Measure Description: Presence of at least one previous episode was defined as: number of episodes in the past 12 months reported and/or number of episodes lifetime reported and/or year of onset of the first symptoms reported.
Participants with at Least One Episode of Hypomania   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants 31 participants 26 participants 48 participants 141 participants
Missing Data 2 0 3 1 6
No 30 1 14 25 70
Yes 4 30 9 22 65
[1]
Measure Description: Presence of at least one previous episode was defined as: number of episodes in the past 12 months reported and/or number of episodes lifetime reported and/or year of onset of the first symptoms reported.
Participants with at Least One Episode of Mania   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants 31 participants 26 participants 48 participants 141 participants
Missing Data 0 3 1 0 4
No 0 14 11 23 48
Yes 36 14 14 25 89
[1]
Measure Description: Presence of at least one previous episode was defined as: number of episodes in the past 12 months reported and/or number of episodes lifetime reported and/or year of onset of the first symptoms reported.
Participants with at Least One Episode of Mixed Episode   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants 31 participants 26 participants 48 participants 141 participants
Missing Data 1 3 1 2 7
No 27 25 3 32 87
Yes 8 3 22 14 47
[1]
Measure Description: Presence of at least one previous episode was defined as: number of episodes in the past 12 months reported and/or number of episodes lifetime reported and/or year of onset of the first symptoms reported.
Patient Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants 31 participants 26 participants 48 participants 141 participants
Inpatient 26 12 10 24 72
Outpatient 10 19 16 24 69
Previous Central Nervous System Treatment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants 31 participants 26 participants 48 participants 141 participants
Yes 34 30 26 46 136
No 2 1 0 2 5
Suicide Ideation   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants 31 participants 26 participants 48 participants 141 participants
0: Absent 35 29 15 26 105
1: Feels Life Not Worth Living 0 2 8 12 22
2:Wishes He Were Dead or Thoughts of Death to Self 1 0 3 10 14
3: Suicide Ideas or Gestures 0 0 0 0 0
4: Attempts Suicide 0 0 0 0 0
[1]
Measure Description: Assessed via the 17-item Hamilton Depression Rating Scale (HAMD-17) item 3. Item 3 assesses presence and level of suicidal ideations.
Thymic Reactivity - Investigator-Based Assessment   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants 31 participants 26 participants 48 participants 141 participants
Neither 1 2 4 3 10
Thymic Hyper-Reactivity 34 28 20 19 101
Thymic Hypo-Reactivity 1 1 2 26 30
[1]
Measure Description: Investigators were asked - according to your clinical experience, is the patient with: neither; thymic hyper-reactivity; or thymic hypo-reactivity.
Age at Time of Onset of First Episode  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 31 participants 26 participants 48 participants 141 participants
30.57  (13.94) 34.00  (13.75) 27.36  (10.78) 29.19  (10.41) 30.29  (12.31)
Body Mass Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram per meter squared
Number Analyzed 36 participants 31 participants 26 participants 48 participants 141 participants
24.80  (4.53) 24.73  (4.98) 26.86  (7.75) 24.54  (3.70) 25.09  (5.18)
[1]
Measure Description: Body mass index is an estimate of body fat based on body weight divided by height squared.
Duration of Current Episode  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 36 participants 31 participants 26 participants 48 participants 141 participants
0.99  (1.51) 1.95  (3.22) 1.71  (1.56) 1.51  (1.49) 1.53  (2.03)
Duration of Illness  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 31 participants 26 participants 48 participants 141 participants
16.86  (13.93) 12.45  (9.52) 19.28  (14.54) 15.70  (11.59) 15.91  (12.46)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 36 participants 31 participants 26 participants 48 participants 141 participants
68.83  (12.34) 69.89  (14.71) 74.42  (20.00) 70.85  (14.41) 70.78  (15.15)
1.Primary Outcome
Title Mean Changes From Baseline to 6 Week and 24 Week Endpoints in the Multidimensional Assessment of THYmic States Scale (MATHYS) Total Score
Hide Description 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.
Time Frame Baseline, 6 Weeks, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.
Arm/Group Title Manic Episode Hypomanic Episode Mixed Episode Depressive Episode
Hide Arm/Group Description:
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
Overall Number of Participants Analyzed 36 31 26 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=34, 31, 25, 48) 140.55  (22.18) 136.52  (22.45) 116.74  (21.30) 76.88  (22.91)
6 Week Endpoint (n=31, 31, 25, 44) 115.37  (23.09) 105.15  (23.10) 101.58  (22.55) 93.41  (23.71)
Change from 6 Week Endpoint (n=30, 31, 24, 44) -22.91  (28.70) -31.37  (30.46) -13.32  (26.37) 17.17  (26.62)
24 Week Endpoint (n=35, 31, 26, 47) 115.15  (24.84) 103.16  (23.03) 91.56  (25.19) 94.58  (27.09)
Change from 24 Week Endpoint (n=34, 31, 25, 47) -24.67  (24.83) -33.36  (33.61) -26.08  (40.51) 17.04  (31.81)
2.Primary Outcome
Title Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix
Hide Description 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.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Matrix based on data from all 141 participants.
Arm/Group Title Eigen Value Proportion Cumulative
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 141 141 141
Measure Type: Number
Unit of Measure: value
Factor 1 8.77 0.4383 0.4383
Factor 2 2.01 0.1006 0.5389
Factor 3 1.19 0.0594 0.5984
Factor 4 1.042 0.0521 0.6505
Factor 5 0.98 0.0490 0.6995
Factor 6 0.79 0.0397 0.7392
Factor 7 0.69 0.0347 0.7739
Factor 8 0.64 0.0322 0.8061
Factor 9 0.56 0.0280 0.8341
Factor 10 0.54 0.0268 0.8608
Factor 11 0.45 0.0227 0.8836
Factor 12 0.44 0.0219 0.9055
Factor 13 0.37 0.0186 0.9241
Factor 14 0.34 0.0171 0.9412
Factor 15 0.28 0.0139 0.9551
Factor 16 0.26 0.0131 0.9682
Factor 17 0.20 0.0100 0.9782
Factor 18 0.18 0.0091 0.9873
Factor 19 0.14 0.0071 0.9944
Factor 20 0.11 0.0056 1.0000
3.Secondary Outcome
Title Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton 17-Items Depression Scale (HAMD-17) Total Score
Hide Description 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).
Time Frame Baseline, 6 Weeks, 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.
Arm/Group Title Manic Episode Hypomanic Episode Mixed Episode Depressive Episode
Hide Arm/Group Description:
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
Overall Number of Participants Analyzed 36 31 26 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=35, 30, 26, 48) 6.46  (4.86) 8.43  (5.33) 12.65  (4.83) 16.06  (7.19)
Change from 6 Week Endpoint (n=29, 29, 25, 45) -1.79  (4.59) -3.10  (4.59) -5.60  (6.60) -8.51  (6.22)
Change from 24 Week Endpoint (n=34, 30, 26, 47) -1.74  (5.02) -3.20  (6.40) -5.50  (6.72) -7.96  (7.18)
4.Secondary Outcome
Title Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton Anxiety Scale (HAMA) Total Score
Hide Description 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).
Time Frame Baseline, 6 Weeks, 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.
Arm/Group Title Manic Episode Hypomanic Episode Mixed Episode Depressive Episode
Hide Arm/Group Description:
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
Overall Number of Participants Analyzed 36 31 26 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=36, 31, 26, 48) 7.78  (6.29) 11.94  (7.73) 15.46  (7.17) 15.08  (7.35)
Change from 6 Week Endpoint (n=31, 31, 25, 45) -2.68  (4.85) -5.48  (5.89) -7.32  (6.31) -6.76  (6.61)
Change from 24 Week Endpoint (n=35, 31, 26, 47) -2.26  (4.80) -5.65  (7.36) -7.62  (7.87) -6.83  (7.19)
5.Secondary Outcome
Title Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Young Mania Rating Scale (YMRS) Total Score
Hide Description 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.
Time Frame Baseline, 6 Weeks, 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.
Arm/Group Title Manic Episode Hypomanic Episode Mixed Episode Depressive Episode
Hide Arm/Group Description:
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
Overall Number of Participants Analyzed 36 31 26 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=36, 31, 25, 46) 24.50  (10.34) 17.84  (4.88) 12.96  (7.69) 2.78  (3.64)
Change from 6 Week Endpoint (n=31, 31, 24, 43) -13.65  (9.38) -13.13  (6.02) -9.67  (7.91) -0.86  (3.54)
Change from 24 Week Endpoint (n=35, 31, 25, 45) -14.00  (10.94) -14.45  (7.36) -10.60  (7.95) -0.82  (3.24)
6.Secondary Outcome
Title Mean Change From Baseline to 24 Week Endpoint in Glycaemia Levels (Glucose Fasting Levels)
Hide Description [Not Specified]
Time Frame baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Manic Episode Hypomanic Episode Mixed Episode Depressive Episode
Hide Arm/Group Description:
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
Overall Number of Participants Analyzed 36 31 26 48
Mean (Standard Deviation)
Unit of Measure: milligrams per deciliter
Baseline (n=33, 30, 23, 47) 89.27  (16.31) 85.99  (11.33) 85.94  (12.58) 88.52  (13.95)
Change from 24 Week Endpoint (n=26, 28, 23, 40) -3.07  (16.15) 4.65  (15.32) 3.89  (9.62) 7.31  (30.42)
7.Secondary Outcome
Title Increases and Decreases in Fasting Glucose Levels
Hide Description [Not Specified]
Time Frame over 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. All participants having been prescribed at least one dose of study drug.
Arm/Group Title Manic Episode Hypomanic Episode Mixed Episode Depressive Episode
Hide Arm/Group Description:
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
Overall Number of Participants Analyzed 36 31 26 48
Measure Type: Number
Unit of Measure: participants
At Least One Increase in Fasting Glucose (FG) 5 9 3 10
At Least One Decrease in FG 4 8 1 11
At Least One Increase/Decrease in FG 7 10 3 15
Patients Who Increase and Decrease During Study 2 7 1 6
8.Secondary Outcome
Title Mean Change From Baseline to 24 Week Endpoint in Lipids
Hide Description 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).
Time Frame Baseline and 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Manic Episode Hypomanic Episode Mixed Episode Depressive Episode
Hide Arm/Group Description:
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
Overall Number of Participants Analyzed 36 31 26 48
Mean (Standard Deviation)
Unit of Measure: milligrams per deciliter
TC Baseline (n=33, 30, 24, 46) 182.88  (41.88) 191.55  (42.49) 210.51  (50.78) 203.77  (44.66)
Change in TC from 24 Week Endpoint (n=26,28,23,41) 23.64  (33.95) 2.26  (27.25) 7.03  (30.77) 4.41  (50.69)
Percent Change in TC (n=26, 28, 23, 41) 14.96  (19.57) 3.10  (13.83) 4.41  (16.97) 4.68  (23.67)
HDL Baseline (n=33, 30, 23, 46) 50.21  (14.65) 56.87  (16.77) 57.46  (19.13) 50.78  (13.35)
Change in HDL from Endpoint (n=26, 28, 22, 41) 1.24  (13.32) 1.57  (13.14) -0.45  (16.27) 3.25  (12.72)
Percent Change in HDL (n=26, 28, 22, 41) 6.04  (26.43) 6.17  (26.06) 3.78  (26.12) 8.87  (23.97)
LDL Baseline (n=34, 30, 23, 46) 112.76  (39.81) 112.16  (31.37) 129.70  (44.64) 128.81  (39.26)
Change in LDL from Endpoint (n=27, 27, 22, 41) 14.22  (41.05) 1.28  (36.64) 9.46  (32.04) -1.19  (42.24)
Percent Change in LDL (n=27, 27, 22, 41) 20.54  (33.94) 5.15  (33.05) 11.37  (28.57) 3.41  (32.28)
TG Baseline (n=35, 30, 23, 46) 115.81  (43.15) 110.66  (89.64) 131.37  (71.65) 120.15  (66.63)
Change in TG from 24 Week Endpoint (n=27,28,22,41) 8.37  (66.50) 25.86  (90.32) -1.16  (49.06) 13.85  (67.59)
Percent Change in TG (n=27, 28, 22, 41) 20.65  (72.42) 40.06  (74.56) 4.10  (36.59) 25.95  (60.73)
9.Secondary Outcome
Title Increases and Decreases in Lipid Levels
Hide Description [Not Specified]
Time Frame over 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. All participants having been prescribed at least one dose of study drug.
Arm/Group Title Manic Episode Hypomanic Episode Mixed Episode Depressive Episode
Hide Arm/Group Description:
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
Overall Number of Participants Analyzed 36 31 26 48
Measure Type: Number
Unit of Measure: participants
At Least One Increase for Total Cholesterol (TC) 18 7 11 20
At Least One Decrease for TC 11 9 10 16
At Least One Increase/Decrease for TC 19 12 14 26
Patients Who Increase & Decrease in TC 10 4 7 10
≥1 Increase for High Density Lipoprotein (HDL) 8 5 6 11
At Least One Decrease for HDL 4 6 5 8
At Least One Increase/Decrease for HDL 9 8 7 12
Patients Who Increase & Decrease in HDL 3 3 4 7
≥1 Increase for Low Density Lipoprotein (LDL) 15 8 11 17
At Least One Decrease for LDL 8 7 7 17
At Least One Increase/Decrease for LDL 17 12 12 25
Patients Who Increase & Decrease in LDL 6 3 6 9
At Least One Increase for Triglycerides (TG) 11 7 6 11
At Least One Decrease for TG 12 7 7 13
At Least One Increase/Decrease for TG 15 11 8 16
Patients Who Increase & Decrease in TG 8 3 5 8
10.Secondary Outcome
Title Mean Change From Baseline to 24 Week Endpoint in Weight
Hide Description [Not Specified]
Time Frame Baseline and 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Manic Episode Hypomanic Episode Mixed Episode Depressive Episode
Hide Arm/Group Description:
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
Overall Number of Participants Analyzed 36 31 26 47
Mean (Standard Deviation)
Unit of Measure: kilograms
1.37  (2.98) 1.91  (3.44) 1.78  (4.43) 2.15  (2.60)
11.Secondary Outcome
Title Weight Gain Compared to Baseline
Hide Description Weight gain at anytime more than 7%-15% or 25% of body weight compared to baseline
Time Frame over 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. All participants having been prescribed at least one dose of study drug.
Arm/Group Title Manic Episode Hypomanic Episode Mixed Episode Depressive Episode
Hide Arm/Group Description:
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
Overall Number of Participants Analyzed 36 31 26 48
Measure Type: Number
Unit of Measure: participants
No Significant Gain 30 26 18 42
>25% 0 0 0 0
>15% 1 2 1 0
>7% 5 3 7 5
Missing Data 0 0 0 1
12.Secondary Outcome
Title Wellness Interventional Program for Weight Gain Management in Patients (for Those Who Gain at Anytime More Than 7% of Body Weight, Compared to Baseline)
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subgroup of patients who gained more than 7% of body weight.
Arm/Group Title Weight Gain Subgroup
Hide Arm/Group Description:
Patients who gained more than 7% of body weight during the study.
Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: participants
Advised to Consult Dietician - No 8
Advised to Consult Dietician - Yes 16
Performed a Wellness Program - No 6
Performed a Wellness Program - Yes 10
Number of Wellnes Program Consults - 1 5
Number of Wellnes Program Consults - 2 2
Number of Wellnes Program Consults - 3 3
Patients Losing Weight After Consultation 8
Patients Gaining Weight After Consultation 8
Patients with Stable Weight After Consultation 0
13.Secondary Outcome
Title MATHYS Total Score at Baseline - According to Thymic Reactivity Assessment
Hide Description 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.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.
Arm/Group Title Thymic Hypo-Reactive Thymic Hyper-Reactivity Neither
Hide Arm/Group Description:
As assessed by the investigator according to his clinical experience.
As assessed by the investigator according to his clinical experience.
As assessed by the investigator according to his clinical experience.
Overall Number of Participants Analyzed 30 101 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
81.24  (30.81) 122.49  (32.01) 117.26  (26.41)
14.Secondary Outcome
Title Change From Baseline to 6 Week and 24 Week Endpoints in HAMA Total Scores - According to Thymic Reactivity Assessment
Hide Description 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).
Time Frame Baseline, 6 Weeks, 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.
Arm/Group Title Thymic Hypo-Reactivity Thymic Hyper-Reactivity Neither
Hide Arm/Group Description:
As assessed by the investigator according to his clinical experience.
As assessed by the investigator according to his clinical experience.
As assessed by the investigator according to his clinical experience.
Overall Number of Participants Analyzed 30 101 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=30, 101, 10) 12.87  (7.09) 12.63  (7.95) 11.40  (7.95)
Change from 6 Week Endpoint (n=29, 93, 10) -4.93  (5.62) -5.96  (6.56) -4.30  (3.95)
Change from 24 Week Endpoint (n=30, 99, 10) -4.83  (5.94) -5.65  (7.39) -6.90  (7.43)
15.Secondary Outcome
Title Change From Baseline to 6 Week and 24 Week Endpoints in HAMD-17 Total Scores - According to Thymic Reactivity Assessment
Hide Description 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).
Time Frame Baseline, 6 Weeks, 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.
Arm/Group Title Thymic Hypo-Reactivity Thymic Hyper-Reactivity Neither
Hide Arm/Group Description:
As assessed by the investigator according to his clinical experience.
As assessed by the investigator according to his clinical experience.
As assessed by the investigator according to his clinical experience.
Overall Number of Participants Analyzed 30 101 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=29, 100, 10) 14.48  (7.02) 10.64  (6.85) 9.50  (7.01)
Change from 6 Week Endpoint (n=28, 90, 10) -6.61  (5.02) -4.89  (6.62) -4.00  (5.12)
Change from 24 Week Endpoint (n=28, 98, 10) -6.48  (4.32) -4.55  (7.58) -3.80  (4.85)
16.Secondary Outcome
Title Change From Baseline to 6 Week and 24 Week Endpoints in YMRS Total Scores - According to Thymic Reactivity Assessment
Hide Description 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.
Time Frame Baseline, 6 Weeks, 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.
Arm/Group Title Thymic Hypo-Reactivity Thymic Hyper-Reactivity Neither
Hide Arm/Group Description:
As assessed by the investigator according to his clinical experience.
As assessed by the investigator according to his clinical experience.
As assessed by the investigator according to his clinical experience.
Overall Number of Participants Analyzed 30 101 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (n=27, 101, 10) 4.48  (7.99) 16.50  (10.65) 10.00  (7.24)
Change from 6 Week Endpoint (n=26, 93, 10) -2.38  (7.90) -10.45  (8.46) -6.50  (4.70)
Change from 24 Week Endpoint (n=27, 99, 10) -1.70  (5.19) -11.29  (9.89) -7.60  (5.52)
17.Secondary Outcome
Title Emotional Reactivity With the Physiological Measure of Heart Rate
Hide Description 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
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Measures were to be collected at only one site. Not enough data to analyze.
Arm/Group Title Manic Episode Hypomanic Episode Mixed Episode Depressive Episode
Hide Arm/Group Description:
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title Emotional Reactivity With the Physiological Measure of Skin Conductance
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Measures were to be collected at only one site. Not enough data to analyze.
Arm/Group Title Manic Episode Hypomanic Episode Mixed Episode Depressive Episode
Hide Arm/Group Description:
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
19.Secondary Outcome
Title Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Latency of Blink
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Measures were to be collected at only one site. Not enough data to analyze.
Arm/Group Title Manic Episode Hypomanic Episode Mixed Episode Depressive Episode
Hide Arm/Group Description:
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
20.Secondary Outcome
Title Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Amplitude of Blink
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Measures were to be collected at only one site. Not enough data to analyze.
Arm/Group Title Manic Episode Hypomanic Episode Mixed Episode Depressive Episode
Hide Arm/Group Description:
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Olanzapine
Hide Arm/Group Description Olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks.
All-Cause Mortality
Olanzapine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Olanzapine
Affected / at Risk (%) # Events
Total   14    
Gastrointestinal disorders   
Gastric ulcer  1  1/141 (0.71%)  1
Hepatobiliary disorders   
Cholecystitis  1  1/141 (0.71%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Squamous cell carcinoma  1  1/141 (0.71%)  1
Psychiatric disorders   
Alcoholism  1  1/141 (0.71%)  1
Anxiety  1  1/141 (0.71%)  1
Bipolar I disorder  1  5/141 (3.55%)  5
Depression  1  4/141 (2.84%)  4
Suicide attempt  1  1/141 (0.71%)  1
Vascular disorders   
Arteritis  1  1/141 (0.71%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Olanzapine
Affected / at Risk (%) # Events
Total   53    
Cardiac disorders   
Palpitations  1  1/141 (0.71%)  1
Ear and labyrinth disorders   
Vertigo  1  1/141 (0.71%)  1
Endocrine disorders   
Hyperprolactinaemia  1  1/141 (0.71%)  1
Hypothyroidism  1  1/141 (0.71%)  1
Eye disorders   
Eye pruritus  1  1/141 (0.71%)  1
Vision blurred  1  2/141 (1.42%)  2
Visual disturbance  1  1/141 (0.71%)  1
Gastrointestinal disorders   
Abdominal pain  1  1/141 (0.71%)  1
Constipation  1  7/141 (4.96%)  7
Diarrhoea  1  2/141 (1.42%)  3
Dry mouth  1  8/141 (5.67%)  8
Gastrointestinal disorder  1  1/141 (0.71%)  1
Nausea  1  1/141 (0.71%)  1
Salivary hypersecretion  1  1/141 (0.71%)  1
Vomiting  1  2/141 (1.42%)  2
General disorders   
Asthenia  1  3/141 (2.13%)  3
Immune system disorders   
Food allergy  1  1/141 (0.71%)  1
Infections and infestations   
Bronchitis  1  1/141 (0.71%)  1
Influenza  1  1/141 (0.71%)  1
Investigations   
Alanine aminotransferase increased  1  1/141 (0.71%)  1
Blood creatine phosphokinase increased  1  1/141 (0.71%)  1
Blood triglycerides increased  1  1/141 (0.71%)  1
Gamma-glutamyltransferase increased  1  2/141 (1.42%)  2
Red blood cell sedimentation rate increased  1  1/141 (0.71%)  1
Transaminases increased  1  1/141 (0.71%)  1
Weight increased  1  3/141 (2.13%)  3
Metabolism and nutrition disorders   
Hypertriglyceridaemia  1  1/141 (0.71%)  1
Increased appetite  1  2/141 (1.42%)  2
Musculoskeletal and connective tissue disorders   
Muscle spasms  1  1/141 (0.71%)  1
Myalgia  1  1/141 (0.71%)  1
Nervous system disorders   
Akathisia  1  1/141 (0.71%)  1
Cognitive disorder  1  1/141 (0.71%)  1
Dizziness  1  2/141 (1.42%)  2
Dysarthria  1  1/141 (0.71%)  1
Headache  1  1/141 (0.71%)  1
Hypertonia  1  1/141 (0.71%)  1
Paraesthesia  1  1/141 (0.71%)  1
Restless legs syndrome  1  1/141 (0.71%)  1
Sedation  1  1/141 (0.71%)  1
Somnolence  1  7/141 (4.96%)  8
Tremor  1  7/141 (4.96%)  7
Psychiatric disorders   
Agitation  1  1/141 (0.71%)  1
Depression  1  1/141 (0.71%)  1
Loss of libido  1  2/141 (1.42%)  2
Memory impairment  1  1/141 (0.71%)  1
Sleep disorder  1  1/141 (0.71%)  1
Suicidal ideation  1  2/141 (1.42%)  2
Suicide attempt  1  1/141 (0.71%)  1
Renal and urinary disorders   
Urinary tract disorder  1  1/141 (0.71%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/141 (0.71%)  1
Skin and subcutaneous tissue disorders   
Photosensitivity reaction  1  1/141 (0.71%)  1
Vascular disorders   
Arteritis  1  1/141 (0.71%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.0
Fewer patients than planned were enrolled in the study. Not all the analyses (Principal Component Analysis, scree plot to define the structure) could be provided due to the specific formatting of the clinicaltrials.gov databank.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00259272     History of Changes
Other Study ID Numbers: 9675
F1D-FP-S057
First Submitted: November 28, 2005
First Posted: November 29, 2005
Results First Submitted: April 30, 2009
Results First Posted: June 24, 2009
Last Update Posted: June 24, 2009