| Primary | Mean Changes From Baseline to 6 Week and 24 Week Endpoints in the Multidimensional Assessment of THYmic States Scale (MATHYS) Total Score | 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. | Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 6 Weeks, 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Manic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG001 | Hypomanic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg) | | OG002 | Mixed Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG003 | Depressive Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg). |
| | Units | Counts |
|---|
| Participants | - OG00036
- OG00131
- OG00226
- OG003
|
| | Title | Denominators | Categories |
|---|
| Baseline (n=34, 31, 25, 48) | | | Title | Measurements |
|---|
| - OG000140.55± 22.18
- OG001136.52± 22.45
- OG002116.74± 21.30
- OG003
|
|
| |
| Secondary | Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton 17-Items Depression Scale (HAMD-17) Total Score | 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). | Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 6 Weeks, 24 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Manic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG001 | Hypomanic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg) | | OG002 | Mixed Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG003 |
|
| Secondary | Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton Anxiety Scale (HAMA) Total Score | 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). | Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 6 Weeks, 24 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Manic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG001 | Hypomanic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg) | | OG002 | Mixed Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG003 |
|
| Secondary | Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Young Mania Rating Scale (YMRS) Total Score | 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. | Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 6 Weeks, 24 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Manic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG001 | Hypomanic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg) | | OG002 | Mixed Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG003 |
|
| Secondary | Mean Change From Baseline to 24 Week Endpoint in Glycaemia Levels (Glucose Fasting Levels) | | 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. | Posted | | Mean | Standard Deviation | milligrams per deciliter | | baseline and 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Manic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG001 | Hypomanic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg) | | OG002 | Mixed Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG003 | Depressive Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg). |
|
| Secondary | Increases and Decreases in Fasting Glucose Levels | | Safety Population. All participants having been prescribed at least one dose of study drug. | Posted | | Number | | participants | | over 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Manic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG001 | Hypomanic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg) | | OG002 | Mixed Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG003 | Depressive Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg). |
| |
| Secondary | Mean Change From Baseline to 24 Week Endpoint in Lipids | 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). | 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. | Posted | | Mean | Standard Deviation | milligrams per deciliter | | Baseline and 24 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Manic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG001 | Hypomanic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg) | | OG002 | Mixed Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG003 | Depressive Episode |
|
| Secondary | Increases and Decreases in Lipid Levels | | Safety Population. All participants having been prescribed at least one dose of study drug. | Posted | | Number | | participants | | over 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Manic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG001 | Hypomanic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg) | | OG002 | Mixed Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG003 | Depressive Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg). |
| |
| Secondary | Mean Change From Baseline to 24 Week Endpoint in Weight | | 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. | Posted | | Mean | Standard Deviation | kilograms | | Baseline and 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Manic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG001 | Hypomanic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg) | | OG002 | Mixed Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG003 | Depressive Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg). |
| |
| Secondary | Weight Gain Compared to Baseline | Weight gain at anytime more than 7%-15% or 25% of body weight compared to baseline | Safety Population. All participants having been prescribed at least one dose of study drug. | Posted | | Number | | participants | | over 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Manic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG001 | Hypomanic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg) | | OG002 | Mixed Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG003 | Depressive Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg). |
|
| Secondary | Wellness Interventional Program for Weight Gain Management in Patients (for Those Who Gain at Anytime More Than 7% of Body Weight, Compared to Baseline) | | Subgroup of patients who gained more than 7% of body weight. | Posted | | Number | | participants | | 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Weight Gain Subgroup | Patients who gained more than 7% of body weight during the study. |
| | |
| Secondary | MATHYS Total Score at Baseline - According to Thymic Reactivity Assessment | 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. | Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Thymic Hypo-Reactive | As assessed by the investigator according to his clinical experience. | | OG001 | Thymic Hyper-Reactivity | As assessed by the investigator according to his clinical experience. | | OG002 | Neither | As assessed by the investigator according to his clinical experience. |
| |
| Secondary | Change From Baseline to 6 Week and 24 Week Endpoints in HAMA Total Scores - According to Thymic Reactivity Assessment | 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). | Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 6 Weeks, 24 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Thymic Hypo-Reactivity | As assessed by the investigator according to his clinical experience. | | OG001 | Thymic Hyper-Reactivity | As assessed by the investigator according to his clinical experience. | | OG002 | Neither | As assessed by the investigator according to his clinical experience. |
| |
| Secondary | Change From Baseline to 6 Week and 24 Week Endpoints in HAMD-17 Total Scores - According to Thymic Reactivity Assessment | 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). | Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 6 Weeks, 24 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Thymic Hypo-Reactivity | As assessed by the investigator according to his clinical experience. | | OG001 | Thymic Hyper-Reactivity | As assessed by the investigator according to his clinical experience. | | OG002 | Neither | As assessed by the investigator according to his clinical experience. |
| |
| Secondary | Change From Baseline to 6 Week and 24 Week Endpoints in YMRS Total Scores - According to Thymic Reactivity Assessment | 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. | Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, 6 Weeks, 24 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Thymic Hypo-Reactivity | As assessed by the investigator according to his clinical experience. | | OG001 | Thymic Hyper-Reactivity | As assessed by the investigator according to his clinical experience. | | OG002 | Neither | As assessed by the investigator according to his clinical experience. |
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| Secondary | Emotional Reactivity With the Physiological Measure of Heart Rate | 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 | Measures were to be collected at only one site. Not enough data to analyze. | Posted | | Mean | Standard Deviation | beats per minute | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Manic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG001 | Hypomanic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg) | | OG002 | Mixed Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG003 | Depressive Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg). |
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| Secondary | Emotional Reactivity With the Physiological Measure of Skin Conductance | 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. | Measures were to be collected at only one site. Not enough data to analyze. | Posted | | Mean | Standard Deviation | microvolts | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Manic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG001 | Hypomanic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg) | | OG002 | Mixed Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG003 | Depressive Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg). |
|
| Secondary | Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Latency of Blink | 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. | Measures were to be collected at only one site. Not enough data to analyze. | Posted | | Mean | Standard Deviation | seconds | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Manic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG001 | Hypomanic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg) | | OG002 | Mixed Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG003 | Depressive Episode | |
|
| Secondary | Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Amplitude of Blink | 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. | Measures were to be collected at only one site. Not enough data to analyze. | Posted | | Mean | Standard Deviation | microvolts | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Manic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG001 | Hypomanic Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg) | | OG002 | Mixed Episode | olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | | OG003 | Depressive Episode | |
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| Primary | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | 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. | Matrix based on data from all 141 participants. | Posted | | Number | | value | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Eigen Value | | | OG001 | Proportion | | | OG002 | Cumulative | |
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