Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. AEs included both serious and all non-serious AEs. |
Screening (2 Weeks prior to Day 1) up to maximum of 5 Weeks after administration of the final dose of study medication (maximum up to 11 weeks) |
|
| Other |
Number of Participants With Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categorization Mapped From Columbia-Suicide Severity Rating Scale (C-SSRS) |
C-SSRS: a measure used to identify and assess participants at risk for suicide. It is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. C-SSRS items were mapped to the following C-CASA categories: completed suicide, attempted suicide (actual attempt; aborted attempt; interrupted attempt), non-suicidal self-injurious behavior, preparatory acts, suicidal ideation (wish to be dead; non-specific active suicidal thoughts; active suicidal ideation with any methods [not plan], without intent to act; active suicidal ideation with some intent to act, without specific plan; active suicidal ideation with specific plan and intent; self-injurious behavior, no suicidal intent). Rows according to C-CASA categories at specified time points are reported in this outcome measure, only when there was non-zero data/values for at least 1 reporting arm. |
Screening (2 Weeks prior to Day 1), Baseline (Day 1), Week 1, 2, 3, 4, Early Termination Visit (anytime from Day 1 to Week 4), Follow up Visit (anytime from Day 1 up to 5 weeks after last dose of study drug = anytime from Day 1 to Week 9) |
|
| Other |
Number of Participants Who Took at Least 1 Concomitant Medication and Concomitant Non-Drug Treatments/Procedures |
Concomitant medications or treatments were those prescription and over-the-counter drugs and supplements or non drug treatment/procedures other than the study medication. |
Screening (2 Weeks prior to Day 1) up to 1 Week after administration of the final dose of study medication (maximum for 7 Weeks) |
|
| Other |
Number of Participants With Laboratory Abnormalities |
Criteria: Hematology-hemoglobin(Hg),hematocrit,erythrocytes(ery)<0.8*LLN,ery mean corpuscular volume <0.9*LLN>1.1*ULN,platelets<0.5*LLN>1.75*ULN,leukocytes(leu)<0.6*LLN>1.5*ULN,lymphocytes(lym),lym/leu,neutrophils(neu),neu/leu<0.8*LLN>1.2*ULN,basophils (bas),bas/leu, eosinophils(eos), eos/leu, monocytes(mon),mon/leu>1.2*ULN; Clinical chemistry bilirubin: total, direct, indirect>1.5*ULN, aspartate aminotransferase,alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase,alkaline phosphatase>3.0*ULN,protein,albumin<0.8*LLN>1.2*ULN,blood urea nitrogen,creatinine>1.3*ULN, urate>1.2*ULN,HDL<0.8*LLN;LDL>1.2*ULN cholesterol(CH),sodium<0.95*LLN>1.05*ULN,potassium, chloride,calcium,magnesium,bicarbonate<0.9*LLLN>1.1*ULN,phosphate,free thyroxine,thyroid stimulating hormone<0.8*LLN>1.2*ULN,prolactin>1.1*ULN,glucose<0.6*LLN>1.5*ULN,HgA1C,CH, triglycerides>1.3*ULN,creatine kinase>2.0*ULN; Urinalysis-specific gravity<1.003>1.030,pH<4.5 >8,urine glucose, protein, Hg, ketones:>=1. |
Screening (2 Weeks prior to Day 1) up to 1 Week after administration of the final dose of study medication (maximum for 7 Weeks) |
|
| Other |
Number of Participants With Physical Examination Abnormalities |
Parameters assessed for physical examination included: oral/tympanic temperature, general appearance, skin, head, ears, eyes, nose, throat, heart, lungs, breasts (if medically indicated), abdomen, external genitalia [if medically indicated], extremities, back/spinal system, lymph nodes or worsening of medical history conditions. Abnormality in physical examination was at the investigator's discretion. |
Screening (2 Weeks prior to Day 1) up to Week 4 |
|
| Other |
Change From Baseline in Blood Pressure at Week 1, 2, 3, 4, Early Termination Visit and Follow-up Visit |
Change from baseline in sitting and standing systolic blood pressure and diastolic blood pressure in millimeter of mercury (mmHg) was reported. |
Baseline, Week 1, 2, 3, 4, Early Termination Visit (anytime from Day 1 to Week 4), Follow up Visit (anytime from Day 1 up to 5 weeks after last dose of study drug = anytime from Day 1 to Week 9) |
|
| Other |
Change From Baseline in Pulse Rate at Week 1, 2, 3, 4, Early Termination Visit and Follow-up Visit |
Change from baseline pulse rate in (beats per minute) was reported in sitting and standing positions. |
Baseline, Week 1, 2, 3, 4, Early Termination Visit (anytime from Day 1 to Week 4), Follow up Visit (anytime from Day 1 up to 5 weeks after last dose of study drug = anytime from Day 1 to Week 9) |
|
| Other |
Change From Baseline in Height and Waist Circumference at Week 4 and Early Termination Visit |
Change from baseline in height and waist circumference in centimeter (cm) was reported. |
Baseline, Week 4, Early Termination Visit (anytime from Day 1 to Week 4) |
|
| Other |
Change From Baseline in Body Weight at Week 4 and Early Termination Visit |
Change from baseline in body weight in kilogram (kg) was reported. |
Baseline, Week 4, Early Termination Visit (anytime from Day 1 to Week 4) |
|
| Other |
Change From Baseline in Body Mass Index (BMI) at Week 4 and Early Termination Visit |
Change from baseline in BMI in kilogram per meter square (kg/m^2) was reported. |
Baseline, Week 4, Early Termination Visit (anytime from Day 1 to Week 4) |
|
| Other |
Change From Baseline in Body Mass Index (BMI) Z-score at Week 4 and Early Termination Visit |
BMI z-score was reported using the Children's Hospital of Philadelphia z-score calculator. Z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of higher BMI. |
Baseline, Week 4, Early Termination Visit (anytime from Day 1 to Week 4) |
|
| Other |
Number of Participants With Pre-defined Categories of Electrocardiogram (ECG) Findings |
Pre-defined categories for ECG were: heart rate intervals - QT interval corrected using the Fridericia's formula (QTCF) value greater than or equal to (>=450) millisecond (msec), >=460 msec, >=480 msec, >=500 msec, >=30 msec increase, >=60 msec increase, >=75 msec increase, QT interval corrected using the Bazett's correction (QTCB) value >=450 msec, >=460 msec, >=480 msec, >=500 msec, >=30 msec increase, >=60 msec increase, >=75 msec increase, PR value >=25 percentage increase, QRS value >=25 percentage increase, QT value >=25 percentage increase, Respiratory rate (RR) value >=25 percentage increase, and Heart rate (HR) value >=25 percentage increase. Rows according to ECG pre-defined categories are reported in this outcome measure, only when there was non-zero data/values for at least 1 reporting arm. |
Screening (2 Weeks prior to Day 1) up to 1 Week after administration of the final dose of study medication (maximum for 7 Weeks) |
|
| Other |
Change From Baseline in Children's Depression Rating Scale (CDRS-R) Total Score at Weeks 1, 2, 3, and 4 and Early Termination Visit |
CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (maximum impairment). Higher scores indicated greater impairment. Total score calculated as sum of the 17 items ranged from 17 (no impairment) to 119 (maximum impairment); higher score indicated greater impairment. |
Baseline, Week 1, 2, 3, 4, Early Termination Visit (anytime from Day 1 to Week 4) |
|
| Other |
Change From Baseline in Simpson-Angus Rating Scale (SARS) Total Score at Weeks 1, 2, 3, and 4 |
SARS: 10-item clinician rated instrument to assess parkinsonian symptoms and related extrapyramidal side effects. All 10 items were anchored on a 5-point scale: range 0 (absence of condition, normal) to 4 (the most extreme form of condition). Total SARS score is sum of all individual item scores, and ranged from 0 (normal) to 40 (most extreme symptoms and effects); higher score indicates more affected. |
Baseline, Week 1, 2, 3, 4 |
|
| Other |
Change From Baseline in Barnes Akathisia Rating Scale (BAS): Global Clinical Assessment of Akathisia Subscale Score at Weeks 1, 2, 3, and 4 |
BAS: clinician rated scale to assess akathisia by determining the degree of subjective restlessness and distress associated with restlessness. First 3 items (objective, subjective, and distress related to restlessness) were rated on a 4-point scale with range 0 (no symptoms) to 3 (maximum severity of symptoms). Item 4, global clinical assessment of akathisia subscale, was rated on a 6-point scale, and ranged from 0 (no symptoms) to 5 (maximum severity of symptoms); higher score indicates increased severity. |
Baseline, Week 1, 2, 3, 4 |
|
| Other |
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) - Movement Cluster Score at Weeks 1, 2, 3, and 4 |
AIMS: clinician rated 12-item scale to document occurrences of dyskinesia in participants, specifically tardive dyskinesia. Items 1 to 10, scored as 0 (none) to 4 (severe); higher score indicates greater severity. Items 11 to 12 are questions with No or Yes response. Only the sum of the first 7 items were calculated to evaluate AIMS movement cluster score, giving a score range of 0 (none) to 28 (maximum severity), higher score indicates greater severity. |
Baseline, Week 1, 2, 3, 4 |
|
| Primary |
Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 4 |
YMRS: an 11-item scale that measured the severity of manic episodes. Four items (irritability, speech, thought content, and disruptive/ aggressive behavior) were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score was sum of score of all 11 items and ranged from 0 (no symptoms) to 60 (extreme severity of symptoms), higher score indicated higher severity of mania. |
Baseline, Week 4 |
|
| Secondary |
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Weeks 1, 2, 3, and 4 |
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill), higher scores indicated more severity of illness. |
Baseline, Week 1, 2, 3, 4 |
|
| Secondary |
Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Weeks 1, 2, and 3 |
YMRS: an 11-item scale that measured the severity of manic episodes. Four items (irritability, speech, thought content, and disruptive/ aggressive behavior) were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score was sum of score of all 11 items and ranged from 0 (no symptoms) to 60 (extreme severity of symptoms), higher score indicated higher severity of mania. |
Baseline, Week 1, 2, 3 |
|
| Secondary |
Clinical Global Impression of Improvement (CGI-I) Scores at Weeks 1, 2, 3, and 4 |
CGI-I: 7-point clinician rated scale which rates the participant's improvement or worsening from baseline, ranging from 1 (very much improved) to 7 (very much worse), higher scores indicate less improvement. |
Baseline, Week 1, 2, 3, 4 |
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