Bipolar Disorder I or II
Conditions
Brief summary
A non randomized study to validate the MATHYS Scale in a population of in and outpatients greater than or equal to 18 years of age, suffering from Bipolar Disorder I or II, and treated with olanzapine.
Interventions
DRUGolanzapine
5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks.
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) disease diagnostic criteria for Bipolar Disorder * currently or most recently in a Manic Episode (Single Manic Episode or Most Recent Episode Manic) or * currently or most recently in a Hypomanic Episode or * currently or most recently in a Mixed Episode or * currently or most recently in a Major Depressive Episode * and confirmed by the module D of the SCID (Semi-Structured Interview). 2. Patients must be more than 18 of age at Visit 0.
Exclusion criteria
1. A valid current or lifetime DSM-IV-TR Axis I or II diagnosis which could interfere, at the investigator's opinion, with the evaluation. 2. Patients on antidepressant or mood stabilizer therapy one week (four weeks with fluoxetine) prior to Visit 1, with the exception of mood stabilizer therapy considered in the opinion of the investigator as an efficient treatment for at least one year prior to the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Changes From Baseline to 6 Week and 24 Week Endpoints in the Multidimensional Assessment of THYmic States Scale (MATHYS) Total Score | Baseline, 6 Weeks, 24 weeks | 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. |
| Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Young Mania Rating Scale (YMRS) Total Score | Baseline, 6 Weeks, 24 Weeks | 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. |
| Mean Change From Baseline to 24 Week Endpoint in Glycaemia Levels (Glucose Fasting Levels) | baseline and 24 weeks | — |
| Increases and Decreases in Fasting Glucose Levels | over 24 weeks | — |
| Mean Change From Baseline to 24 Week Endpoint in Lipids | Baseline and 24 Weeks | 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). |
| Increases and Decreases in Lipid Levels | over 24 weeks | — |
| Mean Change From Baseline to 24 Week Endpoint in Weight | Baseline and 24 weeks | — |
| Weight Gain Compared to Baseline | over 24 weeks | Weight gain at anytime more than 7%-15% or 25% of body weight compared to baseline |
| Wellness Interventional Program for Weight Gain Management in Patients (for Those Who Gain at Anytime More Than 7% of Body Weight, Compared to Baseline) | 24 weeks | — |
| Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton 17-Items Depression Scale (HAMD-17) Total Score | Baseline, 6 Weeks, 24 Weeks | 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). |
| Change From Baseline to 6 Week and 24 Week Endpoints in HAMA Total Scores - According to Thymic Reactivity Assessment | Baseline, 6 Weeks, 24 Weeks | 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). |
| Change From Baseline to 6 Week and 24 Week Endpoints in HAMD-17 Total Scores - According to Thymic Reactivity Assessment | Baseline, 6 Weeks, 24 Weeks | 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). |
| Change From Baseline to 6 Week and 24 Week Endpoints in YMRS Total Scores - According to Thymic Reactivity Assessment | Baseline, 6 Weeks, 24 Weeks | 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. |
| Emotional Reactivity With the Physiological Measure of Heart Rate | 12 weeks | 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 |
| Emotional Reactivity With the Physiological Measure of Skin Conductance | 12 weeks | 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. |
| Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Latency of Blink | 12 weeks | 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. |
| Emotional Reactivity With the Physiological Measure of Startle Reflex Response - Amplitude of Blink | 12 weeks | 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. |
| MATHYS Total Score at Baseline - According to Thymic Reactivity Assessment | Baseline | 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. |
| Mean Change From Baseline to 6 Week and 24 Week Endpoints in the Hamilton Anxiety Scale (HAMA) Total Score | Baseline, 6 Weeks, 24 Weeks | 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). |
Countries
France
Participant flow
Pre-assignment details
All participants received olanzapine and were grouped according to their most recent type of episode.
Participants by arm
| Arm | Count |
|---|---|
| Manic Episode olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | 36 |
| Hypomanic Episode olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg) | 31 |
| Mixed Episode olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg). | 26 |
| Depressive Episode olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg). | 48 |
| Total | 141 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 0 | 3 |
| Overall Study | Lack of Efficacy | 5 | 1 | 2 | 6 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 1 |
| 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 |
Baseline characteristics
| Characteristic | Depressive Episode | Mixed Episode | Total | Hypomanic Episode | Manic Episode |
|---|---|---|---|---|---|
| Age at Time of Onset of First Episode | 29.19 years STANDARD_DEVIATION 10.41 | 27.36 years STANDARD_DEVIATION 10.78 | 30.29 years STANDARD_DEVIATION 12.31 | 34.00 years STANDARD_DEVIATION 13.75 | 30.57 years STANDARD_DEVIATION 13.94 |
| Age Continuous | 44.35 years STANDARD_DEVIATION 11.98 | 46.62 years STANDARD_DEVIATION 12.87 | 45.61 years STANDARD_DEVIATION 12.91 | 45.81 years STANDARD_DEVIATION 11.68 | 46.39 years STANDARD_DEVIATION 15.32 |
| Body Mass Index | 24.54 kilogram per meter squared STANDARD_DEVIATION 3.7 | 26.86 kilogram per meter squared STANDARD_DEVIATION 7.75 | 25.09 kilogram per meter squared STANDARD_DEVIATION 5.18 | 24.73 kilogram per meter squared STANDARD_DEVIATION 4.98 | 24.80 kilogram per meter squared STANDARD_DEVIATION 4.53 |
| Diagnostic Summary Bipolar Disorder I | 31 participants | 26 participants | 107 participants | 14 participants | 36 participants |
| Diagnostic Summary Bipolar Disorder II - Depressed | 17 participants | 1 participants | 18 participants | 0 participants | 0 participants |
| Diagnostic Summary Bipolar Disorder II - Hypomanic | 0 participants | 1 participants | 18 participants | 17 participants | 0 participants |
| Duration of Current Episode | 1.51 months STANDARD_DEVIATION 1.49 | 1.71 months STANDARD_DEVIATION 1.56 | 1.53 months STANDARD_DEVIATION 2.03 | 1.95 months STANDARD_DEVIATION 3.22 | 0.99 months STANDARD_DEVIATION 1.51 |
| Duration of Illness | 15.70 years STANDARD_DEVIATION 11.59 | 19.28 years STANDARD_DEVIATION 14.54 | 15.91 years STANDARD_DEVIATION 12.46 | 12.45 years STANDARD_DEVIATION 9.52 | 16.86 years STANDARD_DEVIATION 13.93 |
| Number of Lifetime Suicide Attempts 0 | 28 participants | 15 participants | 90 participants | 23 participants | 24 participants |
| Number of Lifetime Suicide Attempts 1 | 5 participants | 6 participants | 22 participants | 3 participants | 8 participants |
| Number of Lifetime Suicide Attempts 10 | 1 participants | 1 participants | 2 participants | 0 participants | 0 participants |
| Number of Lifetime Suicide Attempts 2 | 8 participants | 3 participants | 13 participants | 0 participants | 2 participants |
| Number of Lifetime Suicide Attempts 4 | 2 participants | 0 participants | 3 participants | 1 participants | 0 participants |
| Number of Lifetime Suicide Attempts 5 | 2 participants | 0 participants | 2 participants | 0 participants | 0 participants |
| Number of Lifetime Suicide Attempts 6 | 0 participants | 0 participants | 1 participants | 1 participants | 0 participants |
| Number of Lifetime Suicide Attempts Missing Data | 2 participants | 1 participants | 8 participants | 3 participants | 2 participants |
| Participants with at Least One Episode of Depression Missing Data | 0 participants | 1 participants | 1 participants | 0 participants | 0 participants |
| Participants with at Least One Episode of Depression No | 0 participants | 4 participants | 12 participants | 2 participants | 6 participants |
| Participants with at Least One Episode of Depression Yes | 48 participants | 21 participants | 128 participants | 29 participants | 30 participants |
| Participants with at Least One Episode of Hypomania Missing Data | 1 participants | 3 participants | 6 participants | 0 participants | 2 participants |
| Participants with at Least One Episode of Hypomania No | 25 participants | 14 participants | 70 participants | 1 participants | 30 participants |
| Participants with at Least One Episode of Hypomania Yes | 22 participants | 9 participants | 65 participants | 30 participants | 4 participants |
| Participants with at Least One Episode of Mania Missing Data | 0 participants | 1 participants | 4 participants | 3 participants | 0 participants |
| Participants with at Least One Episode of Mania No | 23 participants | 11 participants | 48 participants | 14 participants | 0 participants |
| Participants with at Least One Episode of Mania Yes | 25 participants | 14 participants | 89 participants | 14 participants | 36 participants |
| Participants with at Least One Episode of Mixed Episode Missing Data | 2 participants | 1 participants | 7 participants | 3 participants | 1 participants |
| Participants with at Least One Episode of Mixed Episode No | 32 participants | 3 participants | 87 participants | 25 participants | 27 participants |
| Participants with at Least One Episode of Mixed Episode Yes | 14 participants | 22 participants | 47 participants | 3 participants | 8 participants |
| Patient Status Inpatient | 24 participants | 10 participants | 72 participants | 12 participants | 26 participants |
| Patient Status Outpatient | 24 participants | 16 participants | 69 participants | 19 participants | 10 participants |
| Previous Central Nervous System Treatment No | 2 participants | 0 participants | 5 participants | 1 participants | 2 participants |
| Previous Central Nervous System Treatment Yes | 46 participants | 26 participants | 136 participants | 30 participants | 34 participants |
| Region of Enrollment France | 48 participants | 26 participants | 141 participants | 31 participants | 36 participants |
| Sex: Female, Male Female | 25 Participants | 15 Participants | 80 Participants | 21 Participants | 19 Participants |
| Sex: Female, Male Male | 23 Participants | 11 Participants | 61 Participants | 10 Participants | 17 Participants |
| Suicide Ideation 0: Absent | 26 participants | 15 participants | 105 participants | 29 participants | 35 participants |
| Suicide Ideation 1: Feels Life Not Worth Living | 12 participants | 8 participants | 22 participants | 2 participants | 0 participants |
| Suicide Ideation 2:Wishes He Were Dead or Thoughts of Death to Self | 10 participants | 3 participants | 14 participants | 0 participants | 1 participants |
| Suicide Ideation 3: Suicide Ideas or Gestures | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Suicide Ideation 4: Attempts Suicide | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Thymic Reactivity - Investigator-Based Assessment Neither | 3 participants | 4 participants | 10 participants | 2 participants | 1 participants |
| Thymic Reactivity - Investigator-Based Assessment Thymic Hyper-Reactivity | 19 participants | 20 participants | 101 participants | 28 participants | 34 participants |
| Thymic Reactivity - Investigator-Based Assessment Thymic Hypo-Reactivity | 26 participants | 2 participants | 30 participants | 1 participants | 1 participants |
| Weight | 70.85 kilograms STANDARD_DEVIATION 14.41 | 74.42 kilograms STANDARD_DEVIATION 20 | 70.78 kilograms STANDARD_DEVIATION 15.15 | 69.89 kilograms STANDARD_DEVIATION 14.71 | 68.83 kilograms STANDARD_DEVIATION 12.34 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 53 / — |
| serious Total, serious adverse events | 14 / — |
Outcome results
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.
Time frame: Baseline
Population: Matrix based on data from all 141 participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Manic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 7 | 0.69 value |
| Manic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 3 | 1.19 value |
| Manic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 15 | 0.28 value |
| Manic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 14 | 0.34 value |
| Manic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 9 | 0.56 value |
| Manic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 20 | 0.11 value |
| Manic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 13 | 0.37 value |
| Manic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 10 | 0.54 value |
| Manic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 8 | 0.64 value |
| Manic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 12 | 0.44 value |
| Manic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 11 | 0.45 value |
| Manic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 4 | 1.042 value |
| Manic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 19 | 0.14 value |
| Manic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 18 | 0.18 value |
| Manic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 5 | 0.98 value |
| Manic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 2 | 2.01 value |
| Manic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 17 | 0.20 value |
| Manic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 6 | 0.79 value |
| Manic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 1 | 8.77 value |
| Manic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 16 | 0.26 value |
| Hypomanic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 18 | 0.0091 value |
| Hypomanic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 8 | 0.0322 value |
| Hypomanic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 1 | 0.4383 value |
| Hypomanic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 2 | 0.1006 value |
| Hypomanic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 3 | 0.0594 value |
| Hypomanic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 4 | 0.0521 value |
| Hypomanic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 5 | 0.0490 value |
| Hypomanic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 6 | 0.0397 value |
| Hypomanic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 7 | 0.0347 value |
| Hypomanic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 9 | 0.0280 value |
| Hypomanic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 10 | 0.0268 value |
| Hypomanic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 11 | 0.0227 value |
| Hypomanic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 12 | 0.0219 value |
| Hypomanic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 13 | 0.0186 value |
| Hypomanic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 14 | 0.0171 value |
| Hypomanic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 15 | 0.0139 value |
| Hypomanic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 16 | 0.0131 value |
| Hypomanic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 17 | 0.0100 value |
| Hypomanic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 19 | 0.0071 value |
| Hypomanic Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 20 | 0.0056 value |
| Mixed Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 1 | 0.4383 value |
| Mixed Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 14 | 0.9412 value |
| Mixed Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 7 | 0.7739 value |
| Mixed Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 20 | 1.0000 value |
| Mixed Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 15 | 0.9551 value |
| Mixed Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 6 | 0.7392 value |
| Mixed Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 19 | 0.9944 value |
| Mixed Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 16 | 0.9682 value |
| Mixed Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 5 | 0.6995 value |
| Mixed Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 2 | 0.5389 value |
| Mixed Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 17 | 0.9782 value |
| Mixed Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 4 | 0.6505 value |
| Mixed Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 11 | 0.8836 value |
| Mixed Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 10 | 0.8608 value |
| Mixed Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 3 | 0.5984 value |
| Mixed Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 12 | 0.9055 value |
| Mixed Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 9 | 0.8341 value |
| Mixed Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 18 | 0.9873 value |
| Mixed Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 13 | 0.9241 value |
| Mixed Episode | Baseline MATHYS Assessment - Principal Component Analysis and Orthogonal Transformation Matrix | Factor 8 | 0.8061 value |
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.
Time frame: Baseline, 6 Weeks, 24 weeks
Population: Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Manic Episode | 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 |
| Manic Episode | 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 |
| Manic Episode | 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 |
| Manic Episode | 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 28.7 |
| Manic Episode | 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 |
| Hypomanic Episode | 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) | -31.37 units on a scale | Standard Deviation 30.46 |
| Hypomanic Episode | 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) | 103.16 units on a scale | Standard Deviation 23.03 |
| Hypomanic Episode | 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) | -33.36 units on a scale | Standard Deviation 33.61 |
| Hypomanic Episode | 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) | 105.15 units on a scale | Standard Deviation 23.1 |
| Hypomanic Episode | 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) | 136.52 units on a scale | Standard Deviation 22.45 |
| Mixed Episode | 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) | -13.32 units on a scale | Standard Deviation 26.37 |
| Mixed Episode | 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) | 116.74 units on a scale | Standard Deviation 21.3 |
| Mixed Episode | 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) | 101.58 units on a scale | Standard Deviation 22.55 |
| Mixed Episode | 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) | 91.56 units on a scale | Standard Deviation 25.19 |
| Mixed Episode | 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) | -26.08 units on a scale | Standard Deviation 40.51 |
| Depressive Episode | 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) | 94.58 units on a scale | Standard Deviation 27.09 |
| Depressive Episode | 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) | 93.41 units on a scale | Standard Deviation 23.71 |
| Depressive Episode | 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) | 76.88 units on a scale | Standard Deviation 22.91 |
| Depressive Episode | 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) | 17.17 units on a scale | Standard Deviation 26.62 |
| Depressive Episode | 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) | 17.04 units on a scale | Standard Deviation 31.81 |
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).
Time frame: Baseline, 6 Weeks, 24 Weeks
Population: Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Manic Episode | 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 |
| Manic Episode | 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 |
| Manic Episode | 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 |
| Hypomanic Episode | 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) | -5.96 units on a scale | Standard Deviation 6.56 |
| Hypomanic Episode | Change From Baseline to 6 Week and 24 Week Endpoints in HAMA Total Scores - According to Thymic Reactivity Assessment | Baseline (n=30, 101, 10) | 12.63 units on a scale | Standard Deviation 7.95 |
| Hypomanic Episode | 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) | -5.65 units on a scale | Standard Deviation 7.39 |
| Mixed Episode | Change From Baseline to 6 Week and 24 Week Endpoints in HAMA Total Scores - According to Thymic Reactivity Assessment | Baseline (n=30, 101, 10) | 11.40 units on a scale | Standard Deviation 7.95 |
| Mixed Episode | 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) | -6.90 units on a scale | Standard Deviation 7.43 |
| Mixed Episode | 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) | -4.30 units on a scale | Standard Deviation 3.95 |
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).
Time frame: Baseline, 6 Weeks, 24 Weeks
Population: Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Manic Episode | 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 |
| Manic Episode | 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 |
| Manic Episode | 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 |
| Hypomanic Episode | 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) | -4.89 units on a scale | Standard Deviation 6.62 |
| Hypomanic Episode | 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) | 10.64 units on a scale | Standard Deviation 6.85 |
| Hypomanic Episode | 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) | -4.55 units on a scale | Standard Deviation 7.58 |
| Mixed Episode | 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) | 9.50 units on a scale | Standard Deviation 7.01 |
| Mixed Episode | 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) | -3.80 units on a scale | Standard Deviation 4.85 |
| Mixed Episode | 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) | -4.00 units on a scale | Standard Deviation 5.12 |
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.
Time frame: Baseline, 6 Weeks, 24 Weeks
Population: Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Manic Episode | 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 |
| Manic Episode | 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 |
| Manic Episode | 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 7.9 |
| Hypomanic Episode | 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) | -10.45 units on a scale | Standard Deviation 8.46 |
| Hypomanic Episode | 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) | -11.29 units on a scale | Standard Deviation 9.89 |
| Hypomanic Episode | Change From Baseline to 6 Week and 24 Week Endpoints in YMRS Total Scores - According to Thymic Reactivity Assessment | Baseline (n=27, 101, 10) | 16.50 units on a scale | Standard Deviation 10.65 |
| Mixed Episode | 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) | -7.60 units on a scale | Standard Deviation 5.52 |
| Mixed Episode | Change From Baseline to 6 Week and 24 Week Endpoints in YMRS Total Scores - According to Thymic Reactivity Assessment | Baseline (n=27, 101, 10) | 10.00 units on a scale | Standard Deviation 7.24 |
| Mixed Episode | 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) | -6.50 units on a scale | Standard Deviation 4.7 |
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
Time frame: 12 weeks
Population: Measures were to be collected at only one site. Not enough data to analyze.
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.
Time frame: 12 weeks
Population: Measures were to be collected at only one site. Not enough data to analyze.
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.
Time frame: 12 weeks
Population: Measures were to be collected at only one site. Not enough data to analyze.
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.
Time frame: 12 weeks
Population: Measures were to be collected at only one site. Not enough data to analyze.
Secondary
Increases and Decreases in Fasting Glucose Levels
Time frame: over 24 weeks
Population: Safety Population. All participants having been prescribed at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Manic Episode | Increases and Decreases in Fasting Glucose Levels | At Least One Increase in Fasting Glucose (FG) | 5 participants |
| Manic Episode | Increases and Decreases in Fasting Glucose Levels | At Least One Decrease in FG | 4 participants |
| Manic Episode | Increases and Decreases in Fasting Glucose Levels | At Least One Increase/Decrease in FG | 7 participants |
| Manic Episode | Increases and Decreases in Fasting Glucose Levels | Patients Who Increase and Decrease During Study | 2 participants |
| Hypomanic Episode | Increases and Decreases in Fasting Glucose Levels | At Least One Decrease in FG | 8 participants |
| Hypomanic Episode | Increases and Decreases in Fasting Glucose Levels | At Least One Increase/Decrease in FG | 10 participants |
| Hypomanic Episode | Increases and Decreases in Fasting Glucose Levels | Patients Who Increase and Decrease During Study | 7 participants |
| Hypomanic Episode | Increases and Decreases in Fasting Glucose Levels | At Least One Increase in Fasting Glucose (FG) | 9 participants |
| Mixed Episode | Increases and Decreases in Fasting Glucose Levels | At Least One Increase/Decrease in FG | 3 participants |
| Mixed Episode | Increases and Decreases in Fasting Glucose Levels | At Least One Decrease in FG | 1 participants |
| Mixed Episode | Increases and Decreases in Fasting Glucose Levels | Patients Who Increase and Decrease During Study | 1 participants |
| Mixed Episode | Increases and Decreases in Fasting Glucose Levels | At Least One Increase in Fasting Glucose (FG) | 3 participants |
| Depressive Episode | Increases and Decreases in Fasting Glucose Levels | Patients Who Increase and Decrease During Study | 6 participants |
| Depressive Episode | Increases and Decreases in Fasting Glucose Levels | At Least One Decrease in FG | 11 participants |
| Depressive Episode | Increases and Decreases in Fasting Glucose Levels | At Least One Increase in Fasting Glucose (FG) | 10 participants |
| Depressive Episode | Increases and Decreases in Fasting Glucose Levels | At Least One Increase/Decrease in FG | 15 participants |
Secondary
Increases and Decreases in Lipid Levels
Time frame: over 24 weeks
Population: Safety Population. All participants having been prescribed at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Manic Episode | Increases and Decreases in Lipid Levels | ≥1 Increase for High Density Lipoprotein (HDL) | 8 participants |
| Manic Episode | Increases and Decreases in Lipid Levels | At Least One Decrease for TC | 11 participants |
| Manic Episode | Increases and Decreases in Lipid Levels | At Least One Increase/Decrease for TC | 19 participants |
| Manic Episode | Increases and Decreases in Lipid Levels | Patients Who Increase & Decrease in TC | 10 participants |
| Manic Episode | Increases and Decreases in Lipid Levels | At Least One Increase for Total Cholesterol (TC) | 18 participants |
| Manic Episode | Increases and Decreases in Lipid Levels | At Least One Decrease for HDL | 4 participants |
| Manic Episode | Increases and Decreases in Lipid Levels | At Least One Increase/Decrease for HDL | 9 participants |
| Manic Episode | Increases and Decreases in Lipid Levels | Patients Who Increase & Decrease in HDL | 3 participants |
| Manic Episode | Increases and Decreases in Lipid Levels | ≥1 Increase for Low Density Lipoprotein (LDL) | 15 participants |
| Manic Episode | Increases and Decreases in Lipid Levels | At Least One Decrease for LDL | 8 participants |
| Manic Episode | Increases and Decreases in Lipid Levels | At Least One Increase/Decrease for LDL | 17 participants |
| Manic Episode | Increases and Decreases in Lipid Levels | Patients Who Increase & Decrease in LDL | 6 participants |
| Manic Episode | Increases and Decreases in Lipid Levels | At Least One Increase for Triglycerides (TG) | 11 participants |
| Manic Episode | Increases and Decreases in Lipid Levels | At Least One Decrease for TG | 12 participants |
| Manic Episode | Increases and Decreases in Lipid Levels | At Least One Increase/Decrease for TG | 15 participants |
| Manic Episode | Increases and Decreases in Lipid Levels | Patients Who Increase & Decrease in TG | 8 participants |
| Hypomanic Episode | Increases and Decreases in Lipid Levels | At Least One Decrease for HDL | 6 participants |
| Hypomanic Episode | Increases and Decreases in Lipid Levels | ≥1 Increase for Low Density Lipoprotein (LDL) | 8 participants |
| Hypomanic Episode | Increases and Decreases in Lipid Levels | Patients Who Increase & Decrease in TG | 3 participants |
| Hypomanic Episode | Increases and Decreases in Lipid Levels | Patients Who Increase & Decrease in LDL | 3 participants |
| Hypomanic Episode | Increases and Decreases in Lipid Levels | At Least One Increase/Decrease for TG | 11 participants |
| Hypomanic Episode | Increases and Decreases in Lipid Levels | At Least One Decrease for LDL | 7 participants |
| Hypomanic Episode | Increases and Decreases in Lipid Levels | At Least One Increase/Decrease for TC | 12 participants |
| Hypomanic Episode | Increases and Decreases in Lipid Levels | At Least One Increase/Decrease for LDL | 12 participants |
| Hypomanic Episode | Increases and Decreases in Lipid Levels | ≥1 Increase for High Density Lipoprotein (HDL) | 5 participants |
| Hypomanic Episode | Increases and Decreases in Lipid Levels | At Least One Increase/Decrease for HDL | 8 participants |
| Hypomanic Episode | Increases and Decreases in Lipid Levels | Patients Who Increase & Decrease in TC | 4 participants |
| Hypomanic Episode | Increases and Decreases in Lipid Levels | At Least One Decrease for TC | 9 participants |
| Hypomanic Episode | Increases and Decreases in Lipid Levels | At Least One Increase for Triglycerides (TG) | 7 participants |
| Hypomanic Episode | Increases and Decreases in Lipid Levels | Patients Who Increase & Decrease in HDL | 3 participants |
| Hypomanic Episode | Increases and Decreases in Lipid Levels | At Least One Decrease for TG | 7 participants |
| Hypomanic Episode | Increases and Decreases in Lipid Levels | At Least One Increase for Total Cholesterol (TC) | 7 participants |
| Mixed Episode | Increases and Decreases in Lipid Levels | At Least One Decrease for HDL | 5 participants |
| Mixed Episode | Increases and Decreases in Lipid Levels | ≥1 Increase for High Density Lipoprotein (HDL) | 6 participants |
| Mixed Episode | Increases and Decreases in Lipid Levels | At Least One Decrease for TG | 7 participants |
| Mixed Episode | Increases and Decreases in Lipid Levels | At Least One Increase/Decrease for HDL | 7 participants |
| Mixed Episode | Increases and Decreases in Lipid Levels | Patients Who Increase & Decrease in HDL | 4 participants |
| Mixed Episode | Increases and Decreases in Lipid Levels | Patients Who Increase & Decrease in TG | 5 participants |
| Mixed Episode | Increases and Decreases in Lipid Levels | ≥1 Increase for Low Density Lipoprotein (LDL) | 11 participants |
| Mixed Episode | Increases and Decreases in Lipid Levels | At Least One Decrease for LDL | 7 participants |
| Mixed Episode | Increases and Decreases in Lipid Levels | At Least One Increase/Decrease for TG | 8 participants |
| Mixed Episode | Increases and Decreases in Lipid Levels | At Least One Increase/Decrease for LDL | 12 participants |
| Mixed Episode | Increases and Decreases in Lipid Levels | Patients Who Increase & Decrease in LDL | 6 participants |
| Mixed Episode | Increases and Decreases in Lipid Levels | At Least One Increase for Total Cholesterol (TC) | 11 participants |
| Mixed Episode | Increases and Decreases in Lipid Levels | At Least One Decrease for TC | 10 participants |
| Mixed Episode | Increases and Decreases in Lipid Levels | At Least One Increase for Triglycerides (TG) | 6 participants |
| Mixed Episode | Increases and Decreases in Lipid Levels | At Least One Increase/Decrease for TC | 14 participants |
| Mixed Episode | Increases and Decreases in Lipid Levels | Patients Who Increase & Decrease in TC | 7 participants |
| Depressive Episode | Increases and Decreases in Lipid Levels | Patients Who Increase & Decrease in TG | 8 participants |
| Depressive Episode | Increases and Decreases in Lipid Levels | Patients Who Increase & Decrease in HDL | 7 participants |
| Depressive Episode | Increases and Decreases in Lipid Levels | At Least One Increase/Decrease for TC | 26 participants |
| Depressive Episode | Increases and Decreases in Lipid Levels | At Least One Increase for Total Cholesterol (TC) | 20 participants |
| Depressive Episode | Increases and Decreases in Lipid Levels | At Least One Decrease for TG | 13 participants |
| Depressive Episode | Increases and Decreases in Lipid Levels | At Least One Increase/Decrease for HDL | 12 participants |
| Depressive Episode | Increases and Decreases in Lipid Levels | At Least One Increase for Triglycerides (TG) | 11 participants |
| Depressive Episode | Increases and Decreases in Lipid Levels | At Least One Decrease for TC | 16 participants |
| Depressive Episode | Increases and Decreases in Lipid Levels | ≥1 Increase for High Density Lipoprotein (HDL) | 11 participants |
| Depressive Episode | Increases and Decreases in Lipid Levels | At Least One Decrease for LDL | 17 participants |
| Depressive Episode | Increases and Decreases in Lipid Levels | At Least One Decrease for HDL | 8 participants |
| Depressive Episode | Increases and Decreases in Lipid Levels | At Least One Increase/Decrease for LDL | 25 participants |
| Depressive Episode | Increases and Decreases in Lipid Levels | At Least One Increase/Decrease for TG | 16 participants |
| Depressive Episode | Increases and Decreases in Lipid Levels | ≥1 Increase for Low Density Lipoprotein (LDL) | 17 participants |
| Depressive Episode | Increases and Decreases in Lipid Levels | Patients Who Increase & Decrease in TC | 10 participants |
| Depressive Episode | Increases and Decreases in Lipid Levels | Patients Who Increase & Decrease in LDL | 9 participants |
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.
Time frame: Baseline
Population: Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manic Episode | MATHYS Total Score at Baseline - According to Thymic Reactivity Assessment | 81.24 units on a scale | Standard Deviation 30.81 |
| Hypomanic Episode | MATHYS Total Score at Baseline - According to Thymic Reactivity Assessment | 122.49 units on a scale | Standard Deviation 32.01 |
| Mixed Episode | MATHYS Total Score at Baseline - According to Thymic Reactivity Assessment | 117.26 units on a scale | Standard Deviation 26.41 |
Secondary
Mean Change From Baseline to 24 Week Endpoint in Glycaemia Levels (Glucose Fasting Levels)
Time frame: baseline and 24 weeks
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Manic Episode | 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 |
| Manic Episode | 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 |
| Hypomanic Episode | Mean Change From Baseline to 24 Week Endpoint in Glycaemia Levels (Glucose Fasting Levels) | Change from 24 Week Endpoint (n=26, 28, 23, 40) | 4.65 milligrams per deciliter | Standard Deviation 15.32 |
| Hypomanic Episode | Mean Change From Baseline to 24 Week Endpoint in Glycaemia Levels (Glucose Fasting Levels) | Baseline (n=33, 30, 23, 47) | 85.99 milligrams per deciliter | Standard Deviation 11.33 |
| Mixed Episode | Mean Change From Baseline to 24 Week Endpoint in Glycaemia Levels (Glucose Fasting Levels) | Baseline (n=33, 30, 23, 47) | 85.94 milligrams per deciliter | Standard Deviation 12.58 |
| Mixed Episode | Mean Change From Baseline to 24 Week Endpoint in Glycaemia Levels (Glucose Fasting Levels) | Change from 24 Week Endpoint (n=26, 28, 23, 40) | 3.89 milligrams per deciliter | Standard Deviation 9.62 |
| Depressive Episode | Mean Change From Baseline to 24 Week Endpoint in Glycaemia Levels (Glucose Fasting Levels) | Baseline (n=33, 30, 23, 47) | 88.52 milligrams per deciliter | Standard Deviation 13.95 |
| Depressive Episode | Mean Change From Baseline to 24 Week Endpoint in Glycaemia Levels (Glucose Fasting Levels) | Change from 24 Week Endpoint (n=26, 28, 23, 40) | 7.31 milligrams per deciliter | Standard Deviation 30.42 |
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).
Time frame: Baseline and 24 Weeks
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Manic Episode | 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 |
| Manic Episode | 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 |
| Manic Episode | 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 |
| Manic Episode | 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 |
| Manic Episode | 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 66.5 |
| Manic Episode | 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 |
| Manic Episode | 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 |
| Manic Episode | 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 |
| Manic Episode | 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 |
| Manic Episode | 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 |
| Manic Episode | 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 |
| Manic Episode | 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 |
| Hypomanic Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | Change in TC from 24 Week Endpoint (n=26,28,23,41) | 2.26 milligrams per deciliter | Standard Deviation 27.25 |
| Hypomanic Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | LDL Baseline (n=34, 30, 23, 46) | 112.16 milligrams per deciliter | Standard Deviation 31.37 |
| Hypomanic Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | TC Baseline (n=33, 30, 24, 46) | 191.55 milligrams per deciliter | Standard Deviation 42.49 |
| Hypomanic Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | Percent Change in LDL (n=27, 27, 22, 41) | 5.15 milligrams per deciliter | Standard Deviation 33.05 |
| Hypomanic Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | Change in LDL from Endpoint (n=27, 27, 22, 41) | 1.28 milligrams per deciliter | Standard Deviation 36.64 |
| Hypomanic Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | Percent Change in TC (n=26, 28, 23, 41) | 3.10 milligrams per deciliter | Standard Deviation 13.83 |
| Hypomanic Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | Change in TG from 24 Week Endpoint (n=27,28,22,41) | 25.86 milligrams per deciliter | Standard Deviation 90.32 |
| Hypomanic Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | HDL Baseline (n=33, 30, 23, 46) | 56.87 milligrams per deciliter | Standard Deviation 16.77 |
| Hypomanic Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | Percent Change in TG (n=27, 28, 22, 41) | 40.06 milligrams per deciliter | Standard Deviation 74.56 |
| Hypomanic Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | Change in HDL from Endpoint (n=26, 28, 22, 41) | 1.57 milligrams per deciliter | Standard Deviation 13.14 |
| Hypomanic Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | TG Baseline (n=35, 30, 23, 46) | 110.66 milligrams per deciliter | Standard Deviation 89.64 |
| Hypomanic Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | Percent Change in HDL (n=26, 28, 22, 41) | 6.17 milligrams per deciliter | Standard Deviation 26.06 |
| Mixed Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | Percent Change in TG (n=27, 28, 22, 41) | 4.10 milligrams per deciliter | Standard Deviation 36.59 |
| Mixed Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | TC Baseline (n=33, 30, 24, 46) | 210.51 milligrams per deciliter | Standard Deviation 50.78 |
| Mixed Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | Change in TC from 24 Week Endpoint (n=26,28,23,41) | 7.03 milligrams per deciliter | Standard Deviation 30.77 |
| Mixed Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | Percent Change in TC (n=26, 28, 23, 41) | 4.41 milligrams per deciliter | Standard Deviation 16.97 |
| Mixed Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | HDL Baseline (n=33, 30, 23, 46) | 57.46 milligrams per deciliter | Standard Deviation 19.13 |
| Mixed Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | Change in HDL from Endpoint (n=26, 28, 22, 41) | -0.45 milligrams per deciliter | Standard Deviation 16.27 |
| Mixed Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | Percent Change in HDL (n=26, 28, 22, 41) | 3.78 milligrams per deciliter | Standard Deviation 26.12 |
| Mixed Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | LDL Baseline (n=34, 30, 23, 46) | 129.70 milligrams per deciliter | Standard Deviation 44.64 |
| Mixed Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | Change in LDL from Endpoint (n=27, 27, 22, 41) | 9.46 milligrams per deciliter | Standard Deviation 32.04 |
| Mixed Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | Percent Change in LDL (n=27, 27, 22, 41) | 11.37 milligrams per deciliter | Standard Deviation 28.57 |
| Mixed Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | TG Baseline (n=35, 30, 23, 46) | 131.37 milligrams per deciliter | Standard Deviation 71.65 |
| Mixed Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | Change in TG from 24 Week Endpoint (n=27,28,22,41) | -1.16 milligrams per deciliter | Standard Deviation 49.06 |
| Depressive Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | Percent Change in LDL (n=27, 27, 22, 41) | 3.41 milligrams per deciliter | Standard Deviation 32.28 |
| Depressive Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | Percent Change in HDL (n=26, 28, 22, 41) | 8.87 milligrams per deciliter | Standard Deviation 23.97 |
| Depressive Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | Change in HDL from Endpoint (n=26, 28, 22, 41) | 3.25 milligrams per deciliter | Standard Deviation 12.72 |
| Depressive Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | TC Baseline (n=33, 30, 24, 46) | 203.77 milligrams per deciliter | Standard Deviation 44.66 |
| Depressive Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | TG Baseline (n=35, 30, 23, 46) | 120.15 milligrams per deciliter | Standard Deviation 66.63 |
| Depressive Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | HDL Baseline (n=33, 30, 23, 46) | 50.78 milligrams per deciliter | Standard Deviation 13.35 |
| Depressive Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | Percent Change in TC (n=26, 28, 23, 41) | 4.68 milligrams per deciliter | Standard Deviation 23.67 |
| Depressive Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | Percent Change in TG (n=27, 28, 22, 41) | 25.95 milligrams per deciliter | Standard Deviation 60.73 |
| Depressive Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | Change in TG from 24 Week Endpoint (n=27,28,22,41) | 13.85 milligrams per deciliter | Standard Deviation 67.59 |
| Depressive Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | Change in LDL from Endpoint (n=27, 27, 22, 41) | -1.19 milligrams per deciliter | Standard Deviation 42.24 |
| Depressive Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | LDL Baseline (n=34, 30, 23, 46) | 128.81 milligrams per deciliter | Standard Deviation 39.26 |
| Depressive Episode | Mean Change From Baseline to 24 Week Endpoint in Lipids | Change in TC from 24 Week Endpoint (n=26,28,23,41) | 4.41 milligrams per deciliter | Standard Deviation 50.69 |
Secondary
Mean Change From Baseline to 24 Week Endpoint in Weight
Time frame: Baseline and 24 weeks
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manic Episode | Mean Change From Baseline to 24 Week Endpoint in Weight | 1.37 kilograms | Standard Deviation 2.98 |
| Hypomanic Episode | Mean Change From Baseline to 24 Week Endpoint in Weight | 1.91 kilograms | Standard Deviation 3.44 |
| Mixed Episode | Mean Change From Baseline to 24 Week Endpoint in Weight | 1.78 kilograms | Standard Deviation 4.43 |
| Depressive Episode | Mean Change From Baseline to 24 Week Endpoint in Weight | 2.15 kilograms | Standard Deviation 2.6 |
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).
Time frame: Baseline, 6 Weeks, 24 Weeks
Population: Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Manic Episode | 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 |
| Manic Episode | 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 |
| Manic Episode | 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 |
| Hypomanic Episode | 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) | 8.43 units on a scale | Standard Deviation 5.33 |
| Hypomanic Episode | 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) | -3.20 units on a scale | Standard Deviation 6.4 |
| Hypomanic Episode | 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) | -3.10 units on a scale | Standard Deviation 4.59 |
| Mixed Episode | 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) | -5.60 units on a scale | Standard Deviation 6.6 |
| Mixed Episode | 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) | 12.65 units on a scale | Standard Deviation 4.83 |
| Mixed Episode | 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) | -5.50 units on a scale | Standard Deviation 6.72 |
| Depressive Episode | 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) | 16.06 units on a scale | Standard Deviation 7.19 |
| Depressive Episode | 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) | -7.96 units on a scale | Standard Deviation 7.18 |
| Depressive Episode | 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) | -8.51 units on a scale | Standard Deviation 6.22 |
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).
Time frame: Baseline, 6 Weeks, 24 Weeks
Population: Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Manic Episode | 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 |
| Manic Episode | 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 4.8 |
| Manic Episode | 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 |
| Hypomanic Episode | 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) | 11.94 units on a scale | Standard Deviation 7.73 |
| Hypomanic Episode | 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) | -5.65 units on a scale | Standard Deviation 7.36 |
| Hypomanic Episode | 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) | -5.48 units on a scale | Standard Deviation 5.89 |
| Mixed Episode | 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) | -7.32 units on a scale | Standard Deviation 6.31 |
| Mixed Episode | 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) | 15.46 units on a scale | Standard Deviation 7.17 |
| Mixed Episode | 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) | -7.62 units on a scale | Standard Deviation 7.87 |
| Depressive Episode | 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) | 15.08 units on a scale | Standard Deviation 7.35 |
| Depressive Episode | 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) | -6.83 units on a scale | Standard Deviation 7.19 |
| Depressive Episode | 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) | -6.76 units on a scale | Standard Deviation 6.61 |
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.
Time frame: Baseline, 6 Weeks, 24 Weeks
Population: Intention to treat. Number of participants with baseline and at least one non-missing postbaseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Manic Episode | 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 |
| Manic Episode | 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 |
| Manic Episode | 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 |
| Hypomanic Episode | 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) | -14.45 units on a scale | Standard Deviation 7.36 |
| Hypomanic Episode | 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) | 17.84 units on a scale | Standard Deviation 4.88 |
| Hypomanic Episode | 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) | -13.13 units on a scale | Standard Deviation 6.02 |
| Mixed Episode | 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) | -10.60 units on a scale | Standard Deviation 7.95 |
| Mixed Episode | 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) | -9.67 units on a scale | Standard Deviation 7.91 |
| Mixed Episode | 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) | 12.96 units on a scale | Standard Deviation 7.69 |
| Depressive Episode | 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) | 2.78 units on a scale | Standard Deviation 3.64 |
| Depressive Episode | 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) | -0.82 units on a scale | Standard Deviation 3.24 |
| Depressive Episode | 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) | -0.86 units on a scale | Standard Deviation 3.54 |
Secondary
Weight Gain Compared to Baseline
Weight gain at anytime more than 7%-15% or 25% of body weight compared to baseline
Time frame: over 24 weeks
Population: Safety Population. All participants having been prescribed at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Manic Episode | Weight Gain Compared to Baseline | >15% | 1 participants | — |
| Manic Episode | Weight Gain Compared to Baseline | No Significant Gain | 30 participants | 2.98 |
| Manic Episode | Weight Gain Compared to Baseline | >7% | 5 participants | — |
| Manic Episode | Weight Gain Compared to Baseline | >25% | 0 participants | — |
| Manic Episode | Weight Gain Compared to Baseline | Missing Data | 0 participants | — |
| Hypomanic Episode | Weight Gain Compared to Baseline | >15% | 2 participants | — |
| Hypomanic Episode | Weight Gain Compared to Baseline | >25% | 0 participants | — |
| Hypomanic Episode | Weight Gain Compared to Baseline | >7% | 3 participants | — |
| Hypomanic Episode | Weight Gain Compared to Baseline | No Significant Gain | 26 participants | 3.44 |
| Hypomanic Episode | Weight Gain Compared to Baseline | Missing Data | 0 participants | — |
| Mixed Episode | Weight Gain Compared to Baseline | Missing Data | 0 participants | — |
| Mixed Episode | Weight Gain Compared to Baseline | No Significant Gain | 18 participants | 4.43 |
| Mixed Episode | Weight Gain Compared to Baseline | >25% | 0 participants | — |
| Mixed Episode | Weight Gain Compared to Baseline | >15% | 1 participants | — |
| Mixed Episode | Weight Gain Compared to Baseline | >7% | 7 participants | — |
| Depressive Episode | Weight Gain Compared to Baseline | Missing Data | 1 participants | — |
| Depressive Episode | Weight Gain Compared to Baseline | >7% | 5 participants | — |
| Depressive Episode | Weight Gain Compared to Baseline | >25% | 0 participants | — |
| Depressive Episode | Weight Gain Compared to Baseline | No Significant Gain | 42 participants | 2.6 |
| Depressive Episode | Weight Gain Compared to Baseline | >15% | 0 participants | — |
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)
Time frame: 24 weeks
Population: Subgroup of patients who gained more than 7% of body weight.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Manic Episode | 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 |
| Manic Episode | 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 |
| Manic Episode | 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 |
| Manic Episode | 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 |
| Manic Episode | 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 |
| Manic Episode | 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 |
| Manic Episode | 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 |
| Manic Episode | 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 |
| Manic Episode | 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 |
| Manic Episode | 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 |