Schizophrenia
Conditions
Brief summary
The primary objective of the study was to determine the safety of aripiprazole administered long-term in doses ranging from 10 to 30 mg per day as a maintenance therapy in subjects with chronic or first episode of schizophrenia. Information on the continued efficacy of aripiprazole was also gathered in this long-term trial (until 31 Dec 2012 or until aripiprazole was otherwise available through marketed means and/or reimbursed).
Interventions
DRUGAripiprazole
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
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. Complete a Prior Study: each patient must meet one of the following conditions for completion of the prior study: * A patient who has completed 52 weeks of post-randomization treatment in the prior double blind study (31-97-301 or 31-98-304-01) is eligible, with no further qualifications. * A patient who was early-terminated from the study 31-97-301 or 31-98- 304-01 for either of the following two reasons is eligible to enter this open label study with no minimal required duration of prior double-blind participation: * Early termination was due to a marked deterioration of clinical status and no serious adverse events (SAE) other than hospitalization has occurred. The marked clinical deterioration must be documented by at least a one-point increase in CGI-Severity score from the baseline and a score of 6 (much worse) or 7 (very much worse) in CGI-Global Improvement at the time of termination, or * Early termination was due to a non-serious AE requiring discontinuation of the study drug * A patient who was early terminated after a minimum of 4 weeks' participation in the double-blind treatment in study 31-97-301 or 31-98- 304-01 and the reason for early termination was withdrawal of consent due to lack of effect but not marked deterioration. This must be documented by no change from baseline in the CGI-Severity score and a score of 4 (no change) or 5 (minimally worse) on the CGI-Global Improvement scale. 2. Signing of Informed Consent Form: Prior to any procedure or drug administration, each patient must sign an informed consent form. In addition, if required by the Ethical Committee, each patient's next-of-kin or responsible caregiver will co-sign the patient's consent form or a separate consent form.
Exclusion criteria
1. Patients suffering from any significant somatic disease or medical problem that would obscure the results of treatment, or that might require frequent changes of concomitant medication. 2. Patients with any acute or unstable medical condition requiring pharmacotherapy, other than schizophrenia. 3. Patients with an abnormal laboratory test value in the most recent analysis (from the study 31-97-301 or 31-98-304-01) which is considered by the investigator as presenting a significant risk to the patient for continuing treatment with aripiprazole. 4. Patients who were early-terminated from the prior double-blind studies (31-97-301 or 31-98-304-01) due to a serious adverse event (SAE) other than worsening of psychosis or hospitalization. 5. Female patients of child bearing potential with a positive serum pregnancy test at the baseline (last visit of prior study) of this open-label follow-on study. 6. Patients who have positive result in the urine screen for drugs of abuse (except for cannabis or medically-prescribed analgesics or benzodiazepines.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit | The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). |
| Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit | The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome). |
| Percentage of Participants With Laboratory Values of Potential Clinical Relevance | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit | The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria. |
| Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit | The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). |
| Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit | The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. |
| Mean Clinical Global Impression of Improvement (CGI-I) by Week | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit | The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse. |
| Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit | The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in participants with mood disorders. The questionnaire includes questions on the following symptoms. 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The usual cut-off points are: 0 to 6 = normal/ symptom absent, 7 to 19 = mild depression, 20 to 34 = moderate depression, \>34 = severe depression. |
| Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit | The SAS is composed of 10 items. This scale contains 10 items: Gait, Arm dropping, Shoulder shaking, Elbow rigidity, Wrist rigidity, Head rotation, Glabella Tap, Tremor, Salivation, Akathisia. Grade of severity of each item is rated using a 5-point scale, 1 (normal) and 5 (most severe). The total score ranges from 10 to 50. Negative changes from baseline indicate an improvement, with higher negative values indicating better improvement. |
| Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit | BARS consisted of 4 items: objective observation of akathisia by study physician, subjective feelings of restlessness by participant, participant distress due to akathisia, global evaluation of akathisia. The first 3 items were rated on a 4-point scale: 0 = absence of symptoms to 3 = severe condition. The global clinical evaluation were made on a 6-point scale, (0=absent, 1=questionable, 2=mild, 3=moderate, 4=marked, 5=severe). Participants were observed while they were seated and then stood for a minimum of 2 minutes in each position. Symptoms observed in other situations (e.g., while engaged in neutral conversation or engaged in activity on the ward) may also be rated. Subjective phenomena were elicited by direct questioning. The BARS Global Score was derived from the global clinical assessment of akathisia from the BARS panel. Total score ranges from 0 to 14. Negative changes from baseline indicate improvement, with higher negative values indicating better improvement. |
| Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit | The AIMS assessment consisted of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) were observed unobtrusively while the participant was at rest (e.g., in the waiting room), and the study physician would make global judgments on the participant's dyskinesia's (items 8 through 10). For this scale, the participant was seated on a hard, firm chair. These items are rated on a five-point scale: 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). The total score ranges from 0 to 40. Negative changes from baseline indicate an improvement, with higher negative values indicating better improvement. |
| Number of Participants With Adverse Events (AEs) | Baseline to Last Visit | The AEs were one of the primary parameters to measure the safety and tolerability of individual participants. The AEs were captured for all participants from the time the ICF was signed until the end of the trial. |
| Percentage of Participants With Vital Signs of Potential Clinical Relevance | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit | The vital signs were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance included abnormal values in heart rate, systolic and diastolic blood pressure, respiratory rate and weight that were identified based on pre-defined criteria. |
| Percentage of Participants With ECG Measurements of Potential Clinical Relevance | Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit | The measurement of ECG was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, and QTcF that were identified based on pre-defined criteria. |
Participant flow
Recruitment details
This trial was conducted in 631 participants at 139 trial sites in 23 countries.
Pre-assignment details
All participants enrolled in this trial had previously participated in the double-blind aripiprazole; 89 participants from trial 31-97-301 and 542 participants from trial 31-98-304-01. NCT numbers were not available for these 2 trials as this was before the requirement. Studies were initiated in 1997 (31-97-201) and 1998 (31-98-304-01).
Participants by arm
| Arm | Count |
|---|---|
| Aripiprazole All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events. | 631 |
| Total | 631 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 44 |
| Overall Study | AE of Worsening Schizophrenia | 96 |
| Overall Study | Insufficient Clinical Response | 26 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 21 |
| Overall Study | Met Withdrawal Criteria | 7 |
| Overall Study | Noncompliance | 27 |
| Overall Study | Protocol Violation | 6 |
| Overall Study | Sponsor discontinued trial | 167 |
| Overall Study | Withdrawal by Subject | 236 |
Baseline characteristics
| Characteristic | Aripiprazole |
|---|---|
| Age, Continuous | 37.5 Years STANDARD_DEVIATION 11 |
| Sex: Female, Male Female | 264 Participants |
| Sex: Female, Male Male | 367 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 364 / 631 |
| serious Total, serious adverse events | 179 / 631 |
Outcome results
Primary
Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week
The AIMS assessment consisted of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) were observed unobtrusively while the participant was at rest (e.g., in the waiting room), and the study physician would make global judgments on the participant's dyskinesia's (items 8 through 10). For this scale, the participant was seated on a hard, firm chair. These items are rated on a five-point scale: 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). The total score ranges from 0 to 40. Negative changes from baseline indicate an improvement, with higher negative values indicating better improvement.
Time frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
Population: All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 504 (N= 2) | -0.50 Units on a scale | Standard Deviation 0.71 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 636 (N= 5) | 0.20 Units on a scale | Standard Deviation 0.45 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 648 (N= 2) | 0.00 Units on a scale | Standard Deviation 0 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 660 (N= 3) | 0.00 Units on a scale | Standard Deviation 0 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 672 (N= 1) | 0.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 696 (N= 1) | 0.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 1 (N= 619) | -0.21 Units on a scale | Standard Deviation 1.61 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 6 (N= 572) | -0.34 Units on a scale | Standard Deviation 2.25 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 396 (N= 10) | 0.00 Units on a scale | Standard Deviation 0 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 408 (N= 9) | 0.00 Units on a scale | Standard Deviation 0 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 432 (N= 3) | 0.00 Units on a scale | Standard Deviation 0 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 444 (N= 1) | 0.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 456 (N= 5) | -1.00 Units on a scale | Standard Deviation 2.24 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 468 (N= 2) | 0.00 Units on a scale | Standard Deviation 0 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 480 (N= 1) | 0.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 492 (N= 9) | -0.44 Units on a scale | Standard Deviation 0.53 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 2 (N= 595) | -0.29 Units on a scale | Standard Deviation 1.77 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 4 (N= 586) | -0.28 Units on a scale | Standard Deviation 1.96 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 8 (N= 552) | -0.34 Units on a scale | Standard Deviation 2.22 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 12 (N= 533) | -0.37 Units on a scale | Standard Deviation 2.26 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 16 (N= 517) | -0.39 Units on a scale | Standard Deviation 2.31 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 24 (N= 489) | -0.35 Units on a scale | Standard Deviation 2.08 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 36 (N= 458) | -0.21 Units on a scale | Standard Deviation 1.85 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 48 (N= 425) | -0.35 Units on a scale | Standard Deviation 2.17 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 60 (N= 395) | -0.33 Units on a scale | Standard Deviation 2.02 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 72 (N= 382) | -0.31 Units on a scale | Standard Deviation 2.1 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 84 (N= 362) | -0.31 Units on a scale | Standard Deviation 2.12 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 96 (N= 340) | -0.25 Units on a scale | Standard Deviation 1.84 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 108 (N= 328) | -0.27 Units on a scale | Standard Deviation 1.88 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 120 (N= 316) | -0.26 Units on a scale | Standard Deviation 1.85 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 132 (N= 306) | -0.26 Units on a scale | Standard Deviation 1.91 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 144 (N= 290) | -0.29 Units on a scale | Standard Deviation 1.97 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 156 (N= 279) | -0.31 Units on a scale | Standard Deviation 2.04 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 168 (N= 272) | -0.29 Units on a scale | Standard Deviation 1.87 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 180 (N= 268) | -0.34 Units on a scale | Standard Deviation 2.08 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 192 (N= 255) | -0.35 Units on a scale | Standard Deviation 2.08 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 204 (N= 239) | -0.30 Units on a scale | Standard Deviation 2.06 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 216 (N= 238) | -0.26 Units on a scale | Standard Deviation 1.5 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 228 (N= 224) | -0.31 Units on a scale | Standard Deviation 1.41 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 240 (N= 183) | -0.31 Units on a scale | Standard Deviation 1.44 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 252 (N= 139) | -0.40 Units on a scale | Standard Deviation 1.59 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 264 (N= 83) | -0.61 Units on a scale | Standard Deviation 1.95 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 276 (N= 58) | -0.76 Units on a scale | Standard Deviation 2.3 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 288 (N= 56) | -0.57 Units on a scale | Standard Deviation 2.72 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 300 (N= 55) | -0.18 Units on a scale | Standard Deviation 1.45 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 312 (N= 37) | -0.35 Units on a scale | Standard Deviation 0.68 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 324 (N= 38) | -0.32 Units on a scale | Standard Deviation 0.57 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 336 (N= 28) | -0.36 Units on a scale | Standard Deviation 0.56 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 348 (N= 8) | -0.50 Units on a scale | Standard Deviation 1.07 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 360 (N= 9) | -0.44 Units on a scale | Standard Deviation 0.73 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 372 (N= 3) | 0.00 Units on a scale | Standard Deviation 0 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 384 (N= 5) | 0.00 Units on a scale | Standard Deviation 0 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Week 420 (N= 4) | 0.00 Units on a scale | Standard Deviation 0 |
| Aripiprazole | Mean Change From Baseline in Abnormal Involuntary Movement Scale Score (AIMS) Total Score by Week | Last Visit (N= 629) | -0.39 Units on a scale | Standard Deviation 2.36 |
Primary
Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week
BARS consisted of 4 items: objective observation of akathisia by study physician, subjective feelings of restlessness by participant, participant distress due to akathisia, global evaluation of akathisia. The first 3 items were rated on a 4-point scale: 0 = absence of symptoms to 3 = severe condition. The global clinical evaluation were made on a 6-point scale, (0=absent, 1=questionable, 2=mild, 3=moderate, 4=marked, 5=severe). Participants were observed while they were seated and then stood for a minimum of 2 minutes in each position. Symptoms observed in other situations (e.g., while engaged in neutral conversation or engaged in activity on the ward) may also be rated. Subjective phenomena were elicited by direct questioning. The BARS Global Score was derived from the global clinical assessment of akathisia from the BARS panel. Total score ranges from 0 to 14. Negative changes from baseline indicate improvement, with higher negative values indicating better improvement.
Time frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
Population: All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 36 (N= 458) | -0.21 Units on a scale | Standard Deviation 0.75 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 180 (N= 268) | -0.24 Units on a scale | Standard Deviation 0.81 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 444 (N= 1) | 0.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Last Visit (N= 629) | -0.26 Units on a scale | Standard Deviation 0.85 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 1 (N= 618) | -0.15 Units on a scale | Standard Deviation 0.67 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 2 (N= 595) | -0.20 Units on a scale | Standard Deviation 0.7 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 4 (N= 586) | -0.20 Units on a scale | Standard Deviation 0.74 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 6 (N= 572) | -0.23 Units on a scale | Standard Deviation 0.76 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 8 (N= 552) | -0.22 Units on a scale | Standard Deviation 0.79 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 12 (N= 533) | -0.22 Units on a scale | Standard Deviation 0.78 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 16 (N= 517) | -0.22 Units on a scale | Standard Deviation 0.77 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 24 (N= 489) | -0.22 Units on a scale | Standard Deviation 0.74 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 48 (N= 425) | -0.20 Units on a scale | Standard Deviation 0.75 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 60 (N= 395) | -0.20 Units on a scale | Standard Deviation 0.7 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 72 (N= 382) | -0.19 Units on a scale | Standard Deviation 0.73 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 84 (N= 362) | -0.21 Units on a scale | Standard Deviation 0.74 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 96 (N= 340) | -0.21 Units on a scale | Standard Deviation 0.79 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 108 (N= 327) | -0.21 Units on a scale | Standard Deviation 0.77 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 120 (N= 316) | -0.20 Units on a scale | Standard Deviation 0.75 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 132 (N= 306) | -0.22 Units on a scale | Standard Deviation 0.76 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 144 (N= 291) | -0.22 Units on a scale | Standard Deviation 0.79 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 156 (N= 278) | -0.24 Units on a scale | Standard Deviation 0.79 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 168 (N= 272) | -0.22 Units on a scale | Standard Deviation 0.78 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 192 (N= 255) | -0.29 Units on a scale | Standard Deviation 0.79 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 204 (N= 238) | -0.29 Units on a scale | Standard Deviation 0.8 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 216 (N= 237) | -0.26 Units on a scale | Standard Deviation 0.76 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 228 (N= 223) | -0.26 Units on a scale | Standard Deviation 0.78 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 240 (N= 183) | -0.24 Units on a scale | Standard Deviation 0.75 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 252 (N= 139) | -0.29 Units on a scale | Standard Deviation 0.81 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 264 (N= 83) | -0.51 Units on a scale | Standard Deviation 1.06 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 276 (N= 58) | -0.69 Units on a scale | Standard Deviation 1.16 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 288 (N= 56) | -0.64 Units on a scale | Standard Deviation 1.09 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 300 (N= 55) | -0.51 Units on a scale | Standard Deviation 0.96 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 312 (N= 37) | -0.35 Units on a scale | Standard Deviation 0.68 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 324 (N= 38) | -0.26 Units on a scale | Standard Deviation 0.6 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 336 (N= 28) | -0.29 Units on a scale | Standard Deviation 0.66 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 348 (N= 8) | -0.75 Units on a scale | Standard Deviation 1.04 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 360 (N= 9) | -0.22 Units on a scale | Standard Deviation 0.67 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 372 (N= 3) | 0.00 Units on a scale | Standard Deviation 0 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 384 (N= 5) | 0.00 Units on a scale | Standard Deviation 0 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 396 (N= 10) | -0.10 Units on a scale | Standard Deviation 0.32 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 408 (N= 9) | -0.33 Units on a scale | Standard Deviation 0.71 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 420 (N= 4) | -0.25 Units on a scale | Standard Deviation 0.5 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 432 (N= 3) | 0.00 Units on a scale | Standard Deviation 0 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 456 (N= 5) | -1.40 Units on a scale | Standard Deviation 1.67 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 468 (N= 2) | 0.00 Units on a scale | Standard Deviation 0 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 480 (N= 1) | 0.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 492 (N= 9) | -0.56 Units on a scale | Standard Deviation 1.01 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 504 (N= 2) | -1.50 Units on a scale | Standard Deviation 0.71 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 636 (N= 5) | -0.40 Units on a scale | Standard Deviation 0.89 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 648 (N= 2) | 0.00 Units on a scale | Standard Deviation 0 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 660 (N= 3) | -0.67 Units on a scale | Standard Deviation 1.15 |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 672 (N= 1) | -4.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in Barnes Akathisia Rating Scale Score (BARS) Total Score by Week | Week 696 (N= 1) | 0.00 Units on a scale | — |
Primary
Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week
The severity of illness for each participant was rated using the CGI-S scale. To assess CGI-S, the study physician answered the following question: Considering your total clinical experience with this particular population, how mentally ill is the participant at this time? Response choices included: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants.
Time frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
Population: All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 36 (N= 458) | -0.32 Units on a scale | Standard Deviation 0.95 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 48 (N= 426) | -0.38 Units on a scale | Standard Deviation 0.94 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 60 (N= 395) | -0.45 Units on a scale | Standard Deviation 0.92 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 300 (N= 167) | -0.63 Units on a scale | Standard Deviation 0.99 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 384 (N= 91) | -0.51 Units on a scale | Standard Deviation 0.94 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 528 (N= 19) | -0.47 Units on a scale | Standard Deviation 0.9 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 540 (N= 18) | -0.61 Units on a scale | Standard Deviation 0.7 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 552 (N= 18) | -0.56 Units on a scale | Standard Deviation 0.86 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 564 (N= 17) | -0.41 Units on a scale | Standard Deviation 0.87 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 1 (N= 619) | -0.07 Units on a scale | Standard Deviation 0.49 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 2 (N= 595) | -0.13 Units on a scale | Standard Deviation 0.6 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 4 (N= 586) | -0.20 Units on a scale | Standard Deviation 0.67 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 6 (N= 573) | -0.23 Units on a scale | Standard Deviation 0.78 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 8 (N= 552) | -0.25 Units on a scale | Standard Deviation 0.79 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 12 (N= 533) | -0.25 Units on a scale | Standard Deviation 0.86 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 16 (N= 517) | -0.30 Units on a scale | Standard Deviation 0.86 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 24 (N= 489) | -0.31 Units on a scale | Standard Deviation 0.89 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 72 (N= 382) | -0.45 Units on a scale | Standard Deviation 0.93 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 84 (N= 362) | -0.49 Units on a scale | Standard Deviation 0.95 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 96 (N= 340) | -0.48 Units on a scale | Standard Deviation 0.99 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 108 (N= 328) | -0.51 Units on a scale | Standard Deviation 0.95 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 120 (N= 316) | -0.53 Units on a scale | Standard Deviation 0.98 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 132 (N= 306) | -0.48 Units on a scale | Standard Deviation 1.03 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 144 (N= 290) | -0.52 Units on a scale | Standard Deviation 1.04 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 156 (N= 279) | -0.53 Units on a scale | Standard Deviation 1 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 168 (N= 272) | -0.53 Units on a scale | Standard Deviation 0.96 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 180 (N= 268) | -0.55 Units on a scale | Standard Deviation 0.98 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 192 (N= 255) | -0.54 Units on a scale | Standard Deviation 1.04 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 204 (N= 239) | -0.55 Units on a scale | Standard Deviation 1.01 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 216 (N= 238) | -0.53 Units on a scale | Standard Deviation 0.99 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 228 (N= 232) | -0.56 Units on a scale | Standard Deviation 1 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 240 (N= 216) | -0.56 Units on a scale | Standard Deviation 1.06 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 252 (N= 208) | -0.58 Units on a scale | Standard Deviation 0.96 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 264 (N= 194) | -0.58 Units on a scale | Standard Deviation 1.04 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 276 (N= 187) | -0.61 Units on a scale | Standard Deviation 1.01 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 288 (N= 177) | -0.64 Units on a scale | Standard Deviation 1.02 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 312 (N= 145) | -0.57 Units on a scale | Standard Deviation 1.01 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 324 (N= 137) | -0.60 Units on a scale | Standard Deviation 0.99 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 336 (N= 121) | -0.59 Units on a scale | Standard Deviation 0.95 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 348 (N= 114) | -0.48 Units on a scale | Standard Deviation 0.97 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 360 (N= 105) | -0.54 Units on a scale | Standard Deviation 0.98 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 372 (N= 93) | -0.49 Units on a scale | Standard Deviation 0.94 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 396 (N= 80) | -0.53 Units on a scale | Standard Deviation 1.06 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 408 (N= 69) | -0.62 Units on a scale | Standard Deviation 0.96 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 420 (N= 61) | -0.70 Units on a scale | Standard Deviation 1.07 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 432 (N= 58) | -0.69 Units on a scale | Standard Deviation 1.16 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 444 (N= 51) | -0.59 Units on a scale | Standard Deviation 0.96 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 456 (N= 48) | -0.65 Units on a scale | Standard Deviation 1.1 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 468 (N= 37) | -0.46 Units on a scale | Standard Deviation 1.04 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 480 (N= 33) | -0.42 Units on a scale | Standard Deviation 0.83 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 492 (N= 31) | -0.55 Units on a scale | Standard Deviation 0.99 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 504 (N= 21) | -0.57 Units on a scale | Standard Deviation 0.93 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 516 (N= 19) | -0.53 Units on a scale | Standard Deviation 0.84 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 576 (N= 17) | -0.35 Units on a scale | Standard Deviation 0.86 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 588 (N= 17) | -0.41 Units on a scale | Standard Deviation 0.87 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 600 (N= 16) | -0.44 Units on a scale | Standard Deviation 0.89 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 612 (N= 16) | -0.44 Units on a scale | Standard Deviation 0.89 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 624 (N= 16) | -0.50 Units on a scale | Standard Deviation 0.73 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 636 (N= 16) | -0.44 Units on a scale | Standard Deviation 0.89 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 648 (N= 10) | -0.70 Units on a scale | Standard Deviation 0.67 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 660 (N= 8) | -0.50 Units on a scale | Standard Deviation 0.53 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 672 (N= 3) | -0.67 Units on a scale | Standard Deviation 0.58 |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 684 (N= 1) | -1.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Week 696 (N= 1) | -1.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) by Week | Last Visit (N= 629) | -0.00 Units on a scale | Standard Deviation 1.31 |
Primary
Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score
The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in participants with mood disorders. The questionnaire includes questions on the following symptoms. 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The usual cut-off points are: 0 to 6 = normal/ symptom absent, 7 to 19 = mild depression, 20 to 34 = moderate depression, \>34 = severe depression.
Time frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
Population: All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 1 (N= 619) | -0.78 Units on a scale | Standard Deviation 3.62 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 2 (N= 595) | -1.13 Units on a scale | Standard Deviation 4.09 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 492 (N= 9) | -6.56 Units on a scale | Standard Deviation 8.44 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 660 (N= 3) | -4.33 Units on a scale | Standard Deviation 2.31 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 4 (N= 586) | -1.38 Units on a scale | Standard Deviation 4.73 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 6 (N= 572) | -1.54 Units on a scale | Standard Deviation 5.15 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 8 (N= 552) | -1.40 Units on a scale | Standard Deviation 4.98 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 12 (N= 533) | -1.31 Units on a scale | Standard Deviation 5.77 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 16 (N= 517) | -1.60 Units on a scale | Standard Deviation 5.41 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 24 (N= 489) | -1.61 Units on a scale | Standard Deviation 5.75 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 36 (N= 458) | -1.66 Units on a scale | Standard Deviation 5.75 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 48 (N= 425) | -1.75 Units on a scale | Standard Deviation 5.47 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 60 (N= 395) | -2.13 Units on a scale | Standard Deviation 5.41 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 72 (N= 382) | -2.21 Units on a scale | Standard Deviation 5.29 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 84 (N= 362) | -2.33 Units on a scale | Standard Deviation 5.51 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 96 (N= 339) | -2.26 Units on a scale | Standard Deviation 5.7 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 108 (N= 328) | -2.30 Units on a scale | Standard Deviation 5.68 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 120 (N= 316) | -2.40 Units on a scale | Standard Deviation 5.67 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 132 (N= 306) | -2.22 Units on a scale | Standard Deviation 5.85 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 144 (N= 291) | -2.47 Units on a scale | Standard Deviation 5.85 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 156 (N= 279) | -2.51 Units on a scale | Standard Deviation 5.64 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 168 (N= 272) | -2.51 Units on a scale | Standard Deviation 5.49 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 180 (N= 268) | -2.73 Units on a scale | Standard Deviation 5.67 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 192 (N= 255) | -2.53 Units on a scale | Standard Deviation 6.05 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 204 (N= 239) | -2.69 Units on a scale | Standard Deviation 6.2 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 216 (N= 238) | -2.50 Units on a scale | Standard Deviation 5.87 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 228 (N= 224) | -2.62 Units on a scale | Standard Deviation 5.82 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 240 (N= 183) | -2.92 Units on a scale | Standard Deviation 6.5 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 252 (N= 139) | -3.63 Units on a scale | Standard Deviation 6.53 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 264 (N= 83) | -5.52 Units on a scale | Standard Deviation 7.89 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 276 (N= 58) | -7.71 Units on a scale | Standard Deviation 8.88 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 288 (N= 56) | -7.57 Units on a scale | Standard Deviation 8.64 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 300 (N= 55) | -6.15 Units on a scale | Standard Deviation 7.52 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 312 (N= 37) | -7.24 Units on a scale | Standard Deviation 8.51 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 324 (N= 38) | -6.32 Units on a scale | Standard Deviation 8.76 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 336 (N= 28) | -7.21 Units on a scale | Standard Deviation 8.01 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 348 (N= 8) | -4.00 Units on a scale | Standard Deviation 7.45 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 360 (N= 10) | -2.80 Units on a scale | Standard Deviation 16.09 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 372 (N= 3) | -2.67 Units on a scale | Standard Deviation 2.08 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 384 (N= 5) | 0.00 Units on a scale | Standard Deviation 0 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 396 (N= 10) | -1.40 Units on a scale | Standard Deviation 2.95 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 408 (N= 9) | -1.89 Units on a scale | Standard Deviation 1.27 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 420 (N= 4) | 0.75 Units on a scale | Standard Deviation 4.11 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 432 (N= 3) | -2.33 Units on a scale | Standard Deviation 5.86 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 444 (N= 1) | -1.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 456 (N= 5) | -9.60 Units on a scale | Standard Deviation 8.85 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 468 (N= 2) | -3.00 Units on a scale | Standard Deviation 2.83 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 480 (N= 1) | 0.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 504 (N= 2) | -13.50 Units on a scale | Standard Deviation 13.44 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 636 (N= 5) | 0.40 Units on a scale | Standard Deviation 3.36 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 648 (N= 2) | -1.00 Units on a scale | Standard Deviation 1.41 |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 672 (N= 1) | -2.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Week 696 (N= 1) | -1.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in Montgomery and Asberg Depression Rating Scale (MADRS) Total Score | Last Visit (N= 629) | -0.31 Units on a scale | Standard Deviation 8.02 |
Primary
Mean Change From Baseline in PANSS Negative Sub-scale Score by Week
The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).
Time frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
Population: All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 60 (N= 395) | -2.75 Units on a scale | Standard Deviation 4.38 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 228 (N= 224) | -3.90 Units on a scale | Standard Deviation 5.38 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 300 (N= 55) | -6.58 Units on a scale | Standard Deviation 6.42 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 312 (N= 37) | -7.51 Units on a scale | Standard Deviation 5.43 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 324 (N= 38) | -6.63 Units on a scale | Standard Deviation 4.44 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 360 (N= 10) | -5.60 Units on a scale | Standard Deviation 9.4 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 372 (N= 3) | -4.33 Units on a scale | Standard Deviation 1.53 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 384 (N= 5) | 0.00 Units on a scale | Standard Deviation 2.12 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 432 (N= 3) | -2.67 Units on a scale | Standard Deviation 7.51 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 504 (N= 2) | -1.50 Units on a scale | Standard Deviation 12.02 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 1 (N= 619) | -0.35 Units on a scale | Standard Deviation 2.18 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 2 (N= 595) | -0.82 Units on a scale | Standard Deviation 2.59 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 4 (N= 586) | -1.05 Units on a scale | Standard Deviation 3.04 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 6 (N= 573) | -1.24 Units on a scale | Standard Deviation 3.38 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 8 (N= 552) | -1.41 Units on a scale | Standard Deviation 3.54 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 12 (N= 532) | -1.54 Units on a scale | Standard Deviation 4.01 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 16 (N= 517) | -1.85 Units on a scale | Standard Deviation 4.12 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 24 (N= 489) | -2.02 Units on a scale | Standard Deviation 4.13 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 36 (N= 458) | -2.16 Units on a scale | Standard Deviation 4.41 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 48 (N= 426) | -2.43 Units on a scale | Standard Deviation 4.71 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 72 (N= 382) | -2.94 Units on a scale | Standard Deviation 4.79 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 84 (N= 362) | -3.17 Units on a scale | Standard Deviation 4.87 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 96 (N= 340) | -3.22 Units on a scale | Standard Deviation 4.99 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 108 (N= 328) | -3.36 Units on a scale | Standard Deviation 4.99 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 120 (N= 316) | -3.37 Units on a scale | Standard Deviation 5.25 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 132 (N= 306) | -3.41 Units on a scale | Standard Deviation 5.29 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 144 (N= 288) | -3.58 Units on a scale | Standard Deviation 5.43 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 156 (N= 279) | -3.70 Units on a scale | Standard Deviation 5.27 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 168 (N= 272) | -3.68 Units on a scale | Standard Deviation 5.28 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 180 (N= 268) | -3.69 Units on a scale | Standard Deviation 5.21 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 192 (N= 255) | -3.65 Units on a scale | Standard Deviation 5.4 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 204 (N= 239) | -3.79 Units on a scale | Standard Deviation 5.37 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 216 (N= 238) | -3.74 Units on a scale | Standard Deviation 5.17 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 240 (N= 183) | -4.09 Units on a scale | Standard Deviation 5.86 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 252 (N= 139) | -4.88 Units on a scale | Standard Deviation 5.69 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 264 (N= 83) | -6.87 Units on a scale | Standard Deviation 6.5 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 276 (N= 58) | -8.71 Units on a scale | Standard Deviation 6.57 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 288 (N= 56) | -8.32 Units on a scale | Standard Deviation 6.85 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 336 (N= 28) | -7.43 Units on a scale | Standard Deviation 4.59 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 348 (N= 8) | -4.88 Units on a scale | Standard Deviation 5.89 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 396 (N= 10) | -2.90 Units on a scale | Standard Deviation 3.67 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 408 (N= 9) | -1.22 Units on a scale | Standard Deviation 2.54 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 420 (N= 4) | -2.25 Units on a scale | Standard Deviation 2.22 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 444 (N= 1) | -6.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 456 (N= 4) | -13.75 Units on a scale | Standard Deviation 9.95 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 468 (N= 2) | -9.00 Units on a scale | Standard Deviation 5.66 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 480 (N= 1) | -5.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 492 (N= 9) | -2.00 Units on a scale | Standard Deviation 3.61 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 636 (N= 5) | -1.80 Units on a scale | Standard Deviation 5.85 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 648 (N= 2) | 0.00 Units on a scale | Standard Deviation 0 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 660 (N= 3) | -4.67 Units on a scale | Standard Deviation 6.66 |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 672 (N= 1) | 1.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Week 696 (N= 1) | -3.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in PANSS Negative Sub-scale Score by Week | Last Visit (N= 629) | -1.34 Units on a scale | Standard Deviation 6.09 |
Primary
Mean Change From Baseline in PANSS Positive Sub-scale Score by Week
The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS positive subscale score was the sum of the rating scores for the 7 positive scale items from the PANSS panel. The 7 positive symptom constructs are delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS Positive Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).
Time frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
Population: All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 192 (N= 255) | -2.22 Units on a scale | Standard Deviation 4.91 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 204 (N= 239) | -2.48 Units on a scale | Standard Deviation 4.86 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 240 (N= 183) | -2.10 Units on a scale | Standard Deviation 5.16 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 312 (N= 37) | -5.27 Units on a scale | Standard Deviation 5.57 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 648 (N= 2) | -4.50 Units on a scale | Standard Deviation 7.78 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 660 (N= 3) | -2.00 Units on a scale | Standard Deviation 2.65 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 12 (N= 533) | -1.24 Units on a scale | Standard Deviation 4.43 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 1 (N= 619) | -0.39 Units on a scale | Standard Deviation 2.51 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 2 (N= 595) | -0.81 Units on a scale | Standard Deviation 3.15 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 4 (N= 586) | -1.13 Units on a scale | Standard Deviation 3.47 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 6 (N= 573) | -1.23 Units on a scale | Standard Deviation 3.7 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 8 (N= 552) | -1.30 Units on a scale | Standard Deviation 3.97 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 16 (N= 517) | -1.43 Units on a scale | Standard Deviation 4.2 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 24 (N= 489) | -1.54 Units on a scale | Standard Deviation 4.26 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 36 (N= 458) | -1.56 Units on a scale | Standard Deviation 4.2 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 48 (N= 426) | -1.73 Units on a scale | Standard Deviation 4.64 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 60 (N= 395) | -2.01 Units on a scale | Standard Deviation 4.32 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 72 (N= 382) | -2.08 Units on a scale | Standard Deviation 4.63 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 84 (N= 362) | -2.26 Units on a scale | Standard Deviation 4.65 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 96 (N= 340) | -2.26 Units on a scale | Standard Deviation 4.81 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 108 (N= 328) | -2.50 Units on a scale | Standard Deviation 4.76 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 120 (N= 316) | -2.45 Units on a scale | Standard Deviation 4.84 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 132 (N= 306) | -2.25 Units on a scale | Standard Deviation 5.02 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 144 (N= 289) | -2.49 Units on a scale | Standard Deviation 5.03 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 156 (N= 279) | -2.46 Units on a scale | Standard Deviation 4.87 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 168 (N= 272) | -2.35 Units on a scale | Standard Deviation 4.62 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 180 (N= 268) | -2.40 Units on a scale | Standard Deviation 4.78 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 216 (N= 238) | -2.21 Units on a scale | Standard Deviation 4.57 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 228 (N= 224) | -2.42 Units on a scale | Standard Deviation 4.51 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 252 (N= 139) | -2.74 Units on a scale | Standard Deviation 4.81 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 264 (N= 83) | -4.24 Units on a scale | Standard Deviation 5.69 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 276 (N= 58) | -5.90 Units on a scale | Standard Deviation 5.8 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 288 (N= 56) | -6.30 Units on a scale | Standard Deviation 5.61 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 300 (N= 55) | -4.16 Units on a scale | Standard Deviation 5.54 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 324 (N= 38) | -4.45 Units on a scale | Standard Deviation 5.64 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 336 (N= 28) | -5.46 Units on a scale | Standard Deviation 5.73 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 348 (N= 8) | -0.75 Units on a scale | Standard Deviation 1.04 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 360 (N= 10) | -3.80 Units on a scale | Standard Deviation 7.6 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 372 (N= 3) | -0.67 Units on a scale | Standard Deviation 0.58 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 384 (N= 5) | -0.80 Units on a scale | Standard Deviation 3.96 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 396 (N= 10) | -2.40 Units on a scale | Standard Deviation 3.63 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 408 (N= 9) | -0.89 Units on a scale | Standard Deviation 2.8 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 420 (N= 4) | -0.75 Units on a scale | Standard Deviation 1.5 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 432 (N= 3) | -4.67 Units on a scale | Standard Deviation 8.08 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 444 (N= 1) | -9.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 456 (N= 4) | -10.50 Units on a scale | Standard Deviation 5.97 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 468 (N= 2) | -6.50 Units on a scale | Standard Deviation 3.54 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 480 (N= 1) | -2.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 492 (N= 9) | -2.00 Units on a scale | Standard Deviation 2.65 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 504 (N= 2) | -2.50 Units on a scale | Standard Deviation 7.78 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 636 (N= 5) | -1.80 Units on a scale | Standard Deviation 4.02 |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 672 (N= 1) | 1.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Week 696 (N= 1) | -1.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in PANSS Positive Sub-scale Score by Week | Last Visit (N= 629) | 0.23 Units on a scale | Standard Deviation 6.58 |
Primary
Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week
The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS total score was the sum of the rating scores for 7 positive scale items, 7 negative scale items, and 16 general psychopathology scale items from the PANSS panel. The PANSS total score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Time frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
Population: All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 348 (N= 8) | -12.88 Units on a scale | Standard Deviation 14.71 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 432 (N= 3) | -13.67 Units on a scale | Standard Deviation 24.19 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 456 (N= 4) | -48.25 Units on a scale | Standard Deviation 32.12 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 1 (N= 619) | -1.63 Units on a scale | Standard Deviation 7.92 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 2 (N= 595) | -3.19 Units on a scale | Standard Deviation 9.64 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 4 (N= 586) | -4.27 Units on a scale | Standard Deviation 10.9 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 6 (N= 573) | -4.93 Units on a scale | Standard Deviation 12.07 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 8 (N= 552) | -5.35 Units on a scale | Standard Deviation 13.03 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 12 (N= 532) | -5.47 Units on a scale | Standard Deviation 14.61 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 16 (N= 517) | -6.28 Units on a scale | Standard Deviation 14.44 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 24 (N= 489) | -6.78 Units on a scale | Standard Deviation 14.22 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 36 (N= 458) | -7.22 Units on a scale | Standard Deviation 14.17 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 48 (N= 426) | -8.07 Units on a scale | Standard Deviation 15.72 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 60 (N= 395) | -9.28 Units on a scale | Standard Deviation 14.71 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 72 (N= 382) | -9.81 Units on a scale | Standard Deviation 15.98 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 84 (N= 362) | -10.54 Units on a scale | Standard Deviation 15.92 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 96 (N= 340) | -10.68 Units on a scale | Standard Deviation 16.4 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 108 (N= 328) | -11.46 Units on a scale | Standard Deviation 16.56 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 120 (N= 316) | -11.43 Units on a scale | Standard Deviation 17.01 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 132 (N= 306) | -11.05 Units on a scale | Standard Deviation 17.37 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 144 (N= 288) | -11.70 Units on a scale | Standard Deviation 17.72 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 156 (N= 279) | -11.90 Units on a scale | Standard Deviation 17.47 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 168 (N= 272) | -11.69 Units on a scale | Standard Deviation 17.11 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 180 (N= 268) | -11.83 Units on a scale | Standard Deviation 17.41 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 192 (N= 255) | -11.46 Units on a scale | Standard Deviation 18 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 204 (N= 239) | -12.10 Units on a scale | Standard Deviation 17.72 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 216 (N= 238) | -11.54 Units on a scale | Standard Deviation 17.05 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 228 (N= 224) | -12.24 Units on a scale | Standard Deviation 17.53 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 240 (N= 183) | -12.14 Units on a scale | Standard Deviation 19.35 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 252 (N= 139) | -15.19 Units on a scale | Standard Deviation 18.61 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 264 (N= 83) | -22.16 Units on a scale | Standard Deviation 21.07 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 276 (N= 58) | -29.45 Units on a scale | Standard Deviation 20.33 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 288 (N= 56) | -28.79 Units on a scale | Standard Deviation 20.66 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 300 (N= 55) | -21.95 Units on a scale | Standard Deviation 19.91 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 312 (N= 37) | -25.35 Units on a scale | Standard Deviation 18.41 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 324 (N= 38) | -21.95 Units on a scale | Standard Deviation 17.45 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 336 (N= 28) | -24.86 Units on a scale | Standard Deviation 17.78 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 360 (N= 10) | -17.70 Units on a scale | Standard Deviation 35.32 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 372 (N= 3) | -10.67 Units on a scale | Standard Deviation 4.16 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 384 (N= 5) | -4.60 Units on a scale | Standard Deviation 9.07 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 396 (N= 10) | -10.10 Units on a scale | Standard Deviation 12.67 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 408 (N= 9) | -5.56 Units on a scale | Standard Deviation 7.06 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 420 (N= 4) | -8.00 Units on a scale | Standard Deviation 2.83 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 444 (N= 1) | -28.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 468 (N= 2) | -36.00 Units on a scale | Standard Deviation 2.83 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 480 (N= 1) | -10.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 492 (N= 9) | -10.00 Units on a scale | Standard Deviation 13.52 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 504 (N= 2) | -9.50 Units on a scale | Standard Deviation 28.99 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 636 (N= 5) | -7.60 Units on a scale | Standard Deviation 22.35 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 648 (N= 2) | -10.00 Units on a scale | Standard Deviation 14.14 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 660 (N= 3) | -15.33 Units on a scale | Standard Deviation 19.66 |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 672 (N= 1) | 1.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Week 696 (N= 1) | -7.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Week | Last Visit (N= 629) | -2.30 Units on a scale | Standard Deviation 22.21 |
Primary
Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week
The SAS is composed of 10 items. This scale contains 10 items: Gait, Arm dropping, Shoulder shaking, Elbow rigidity, Wrist rigidity, Head rotation, Glabella Tap, Tremor, Salivation, Akathisia. Grade of severity of each item is rated using a 5-point scale, 1 (normal) and 5 (most severe). The total score ranges from 10 to 50. Negative changes from baseline indicate an improvement, with higher negative values indicating better improvement.
Time frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
Population: All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 1 (N= 618) | -0.78 Units on a scale | Standard Deviation 3.05 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 4 (N= 585) | -1.06 Units on a scale | Standard Deviation 3.68 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 6 (N= 572) | -1.14 Units on a scale | Standard Deviation 3.94 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 8 (N= 550) | -1.19 Units on a scale | Standard Deviation 4 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 204 (N= 239) | -1.49 Units on a scale | Standard Deviation 4.16 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 432 (N= 3) | -1.00 Units on a scale | Standard Deviation 1.73 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 456 (N= 5) | -7.20 Units on a scale | Standard Deviation 8.87 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 468 (N= 2) | 0.00 Units on a scale | Standard Deviation 0 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 480 (N= 1) | -1.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 696 (N= 1) | -7.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Last Visit (N= 628) | -1.36 Units on a scale | Standard Deviation 4.31 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 2 (N= 594) | -1.01 Units on a scale | Standard Deviation 3.32 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 12 (N= 532) | -1.28 Units on a scale | Standard Deviation 4.03 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 16 (N= 516) | -1.27 Units on a scale | Standard Deviation 4.18 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 24 (N= 488) | -1.24 Units on a scale | Standard Deviation 3.91 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 36 (N= 456) | -1.10 Units on a scale | Standard Deviation 3.79 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 48 (N= 426) | -1.33 Units on a scale | Standard Deviation 4.14 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 60 (N= 395) | -1.25 Units on a scale | Standard Deviation 3.89 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 72 (N= 382) | -1.36 Units on a scale | Standard Deviation 4.07 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 84 (N= 362) | -1.33 Units on a scale | Standard Deviation 4.16 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 96 (N= 338) | -1.24 Units on a scale | Standard Deviation 3.92 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 108 (N= 328) | -1.29 Units on a scale | Standard Deviation 3.83 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 120 (N= 316) | -1.22 Units on a scale | Standard Deviation 3.83 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 132 (N= 306) | -1.26 Units on a scale | Standard Deviation 3.88 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 144 (N= 289) | -1.26 Units on a scale | Standard Deviation 3.99 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 156 (N= 278) | -1.33 Units on a scale | Standard Deviation 4.04 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 168 (N= 272) | -1.31 Units on a scale | Standard Deviation 3.92 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 180 (N= 268) | -1.43 Units on a scale | Standard Deviation 4.08 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 192 (N= 255) | -1.46 Units on a scale | Standard Deviation 4.07 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 216 (N= 238) | -1.39 Units on a scale | Standard Deviation 3.48 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 228 (N= 224) | -1.44 Units on a scale | Standard Deviation 3.55 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 240 (N= 183) | -1.68 Units on a scale | Standard Deviation 3.72 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 252 (N= 139) | -2.11 Units on a scale | Standard Deviation 4.16 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 264 (N= 83) | -2.89 Units on a scale | Standard Deviation 4.99 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 276 (N= 58) | -3.84 Units on a scale | Standard Deviation 5.64 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 288 (N= 56) | -3.88 Units on a scale | Standard Deviation 5.77 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 300 (N= 55) | -2.53 Units on a scale | Standard Deviation 4.55 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 312 (N= 37) | -2.30 Units on a scale | Standard Deviation 4.07 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 324 (N= 38) | -1.76 Units on a scale | Standard Deviation 4.1 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 336 (N= 28) | -1.64 Units on a scale | Standard Deviation 3.9 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 348 (N= 8) | -2.00 Units on a scale | Standard Deviation 2.78 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 360 (N= 9) | -0.44 Units on a scale | Standard Deviation 5.75 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 372 (N= 3) | -1.00 Units on a scale | Standard Deviation 0 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 384 (N= 5) | -0.20 Units on a scale | Standard Deviation 0.45 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 396 (N= 10) | -0.30 Units on a scale | Standard Deviation 1.16 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 408 (N= 9) | -0.89 Units on a scale | Standard Deviation 1.27 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 420 (N= 4) | -1.25 Units on a scale | Standard Deviation 1.5 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 444 (N= 1) | 1.00 Units on a scale | — |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 492 (N= 9) | -3.22 Units on a scale | Standard Deviation 5.33 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 504 (N= 2) | -3.00 Units on a scale | Standard Deviation 4.24 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 636 (N= 5) | -0.20 Units on a scale | Standard Deviation 0.45 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 648 (N= 2) | 0.00 Units on a scale | Standard Deviation 0 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 660 (N= 3) | -1.00 Units on a scale | Standard Deviation 1 |
| Aripiprazole | Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score by Week | Week 672 (N= 1) | -3.00 Units on a scale | — |
Primary
Mean Clinical Global Impression of Improvement (CGI-I) by Week
The efficacy of trial medication were rated for each participant using the CGI-I scale. The study physician must rate the participant's total improvement whether or not it is due entirely to drug treatment. All responses were compared to the participant's condition at baseline. Response choices include: 0 = not assessed; 1 =very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 =minimally worse; 6 = much worse; and 7 = very much worse.
Time frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
Population: All participants who had received at least one dose of study medication were included in both efficacy and safety analyses dataset.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 1 (N= 619) | 3.60 Units on a scale | Standard Deviation 0.93 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 2 (N= 595) | 3.42 Units on a scale | Standard Deviation 0.98 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 120 (N= 316) | 2.58 Units on a scale | Standard Deviation 1.15 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 192 (N= 255) | 2.59 Units on a scale | Standard Deviation 1.2 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 204 (N= 239) | 2.56 Units on a scale | Standard Deviation 1.16 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 216 (N= 238) | 2.56 Units on a scale | Standard Deviation 1.2 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 372 (N= 93) | 2.14 Units on a scale | Standard Deviation 1.07 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 432 (N= 58) | 2.00 Units on a scale | Standard Deviation 1.73 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 444 (N= 51) | 1.00 Units on a scale | — |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 456 (N= 48) | 1.83 Units on a scale | Standard Deviation 0.75 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 528 (N= 1) | 4.00 Units on a scale | — |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 636 (N= 5) | 2.00 Units on a scale | Standard Deviation 0 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 4 (N= 586) | 3.29 Units on a scale | Standard Deviation 1.02 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 6 (N= 573) | 3.21 Units on a scale | Standard Deviation 1.08 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 8 (N= 552) | 3.17 Units on a scale | Standard Deviation 1.1 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 12 (N= 533) | 3.16 Units on a scale | Standard Deviation 1.12 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 16 (N= 517) | 3.08 Units on a scale | Standard Deviation 1.18 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 24 (N= 489) | 3.03 Units on a scale | Standard Deviation 1.14 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 36 (N= 458) | 2.95 Units on a scale | Standard Deviation 1.14 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 48 (N= 426) | 2.88 Units on a scale | Standard Deviation 1.17 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 60 (N= 395) | 2.76 Units on a scale | Standard Deviation 1.14 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 72 (N= 382) | 2.73 Units on a scale | Standard Deviation 1.11 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 84 (N= 362) | 2.67 Units on a scale | Standard Deviation 1.11 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 96 (N= 340) | 2.67 Units on a scale | Standard Deviation 1.15 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 108 (N= 328) | 2.60 Units on a scale | Standard Deviation 1.12 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 132 (N= 306) | 2.62 Units on a scale | Standard Deviation 1.17 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 144 (N= 290) | 2.59 Units on a scale | Standard Deviation 1.2 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 156 (N= 279) | 2.58 Units on a scale | Standard Deviation 1.16 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 168 (N= 272) | 2.57 Units on a scale | Standard Deviation 1.15 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 180 (N= 268) | 2.57 Units on a scale | Standard Deviation 1.16 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 228 (N= 232) | 2.49 Units on a scale | Standard Deviation 1.17 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 240 (N= 216) | 2.48 Units on a scale | Standard Deviation 1.21 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 252 (N= 208) | 2.37 Units on a scale | Standard Deviation 1.13 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 264 (N= 194) | 2.14 Units on a scale | Standard Deviation 1.07 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 276 (N= 187) | 2.16 Units on a scale | Standard Deviation 1.03 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 288 (N= 177) | 2.26 Units on a scale | Standard Deviation 1.06 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 300 (N= 167) | 2.26 Units on a scale | Standard Deviation 1.16 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 312 (N= 145) | 2.18 Units on a scale | Standard Deviation 1.11 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 324 (N= 137) | 2.23 Units on a scale | Standard Deviation 1.05 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 336 (N= 121) | 2.03 Units on a scale | Standard Deviation 1.09 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 348 (N= 114) | 2.45 Units on a scale | Standard Deviation 1 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 360 (N= 105) | 2.53 Units on a scale | Standard Deviation 1.36 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 384 (N= 91) | 2.50 Units on a scale | Standard Deviation 1.52 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 396 (N= 80) | 3.00 Units on a scale | Standard Deviation 1.63 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 408 (N= 69) | 2.50 Units on a scale | Standard Deviation 1.18 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 420 (N= 61) | 2.43 Units on a scale | Standard Deviation 1.4 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 468 (N= 37) | 2.00 Units on a scale | Standard Deviation 0 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 480 (N= 33) | 2.00 Units on a scale | — |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 492 (N= 9) | 2.33 Units on a scale | Standard Deviation 1.32 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 504 (N= 2) | 2.50 Units on a scale | Standard Deviation 2.12 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 648 (N= 2) | 1.50 Units on a scale | Standard Deviation 0.71 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 660 (N= 3) | 2.33 Units on a scale | Standard Deviation 1.15 |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 672 (N= 3) | 1.00 Units on a scale | — |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Week 696 (N= 1) | 1.00 Units on a scale | — |
| Aripiprazole | Mean Clinical Global Impression of Improvement (CGI-I) by Week | Last Visit (N= 629) | 3.35 Units on a scale | Standard Deviation 1.6 |
Primary
Number of Participants With Adverse Events (AEs)
The AEs were one of the primary parameters to measure the safety and tolerability of individual participants. The AEs were captured for all participants from the time the ICF was signed until the end of the trial.
Time frame: Baseline to Last Visit
Population: Safety Sample includes all randomized participants who receive at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aripiprazole | Number of Participants With Adverse Events (AEs) | Participants with serious TEAEs | 179 Participants |
| Aripiprazole | Number of Participants With Adverse Events (AEs) | Participants with severe TEAEs | 116 Participants |
| Aripiprazole | Number of Participants With Adverse Events (AEs) | Participants discontinued medication due to AE | 140 Participants |
| Aripiprazole | Number of Participants With Adverse Events (AEs) | Participants with TEAEs | 523 Participants |
| Aripiprazole | Number of Participants With Adverse Events (AEs) | Participants discontinued due to AEs or death | 140 Participants |
Primary
Percentage of Participants With ECG Measurements of Potential Clinical Relevance
The measurement of ECG was one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal changes in heart rate and ECG intervals of PR, QRS, QT, QTcB, and QTcF that were identified based on pre-defined criteria.
Time frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
Population: Safety Sample includes all randomized participants who receive at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aripiprazole | Percentage of Participants With ECG Measurements of Potential Clinical Relevance | Tachycardia (N=612) | 0.8 Percentage of participants |
| Aripiprazole | Percentage of Participants With ECG Measurements of Potential Clinical Relevance | Bradycardia (N=612) | 7.5 Percentage of participants |
| Aripiprazole | Percentage of Participants With ECG Measurements of Potential Clinical Relevance | Sinus tachycardia (N=612) | 0.8 Percentage of participants |
| Aripiprazole | Percentage of Participants With ECG Measurements of Potential Clinical Relevance | Sinus bradycardia (N=612) | 7.4 Percentage of participants |
| Aripiprazole | Percentage of Participants With ECG Measurements of Potential Clinical Relevance | Ventricular premature beat (N=612) | 2.9 Percentage of participants |
| Aripiprazole | Percentage of Participants With ECG Measurements of Potential Clinical Relevance | Primary atrioventricular block (N=606) | 2.5 Percentage of participants |
| Aripiprazole | Percentage of Participants With ECG Measurements of Potential Clinical Relevance | Secondary atrioventricular block (N=612) | 0.2 Percentage of participants |
| Aripiprazole | Percentage of Participants With ECG Measurements of Potential Clinical Relevance | Left bundle branch block (N=612) | 0.2 Percentage of participants |
| Aripiprazole | Percentage of Participants With ECG Measurements of Potential Clinical Relevance | Right bundle branch block (N=612) | 16.0 Percentage of participants |
| Aripiprazole | Percentage of Participants With ECG Measurements of Potential Clinical Relevance | Pre-excitation syndrome (N=612) | 0.3 Percentage of participants |
| Aripiprazole | Percentage of Participants With ECG Measurements of Potential Clinical Relevance | Other intraventricular conduction block (N=611) | 1.8 Percentage of participants |
| Aripiprazole | Percentage of Participants With ECG Measurements of Potential Clinical Relevance | Acute infarction (N=612) | 0.2 Percentage of participants |
| Aripiprazole | Percentage of Participants With ECG Measurements of Potential Clinical Relevance | Old infarction (N=612) | 0.7 Percentage of participants |
| Aripiprazole | Percentage of Participants With ECG Measurements of Potential Clinical Relevance | QTcB (N=612) | 8.0 Percentage of participants |
| Aripiprazole | Percentage of Participants With ECG Measurements of Potential Clinical Relevance | QTcF (N=611) | 2.1 Percentage of participants |
| Aripiprazole | Percentage of Participants With ECG Measurements of Potential Clinical Relevance | QTcN (N=611) | 2.3 Percentage of participants |
Primary
Percentage of Participants With Laboratory Values of Potential Clinical Relevance
The laboratory values were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance include abnormal values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria.
Time frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
Population: Safety Sample includes all randomized participants who receive at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aripiprazole | Percentage of Participants With Laboratory Values of Potential Clinical Relevance | Sodium (meq/l) (low) (N=626) | 0.5 Percentage of participants |
| Aripiprazole | Percentage of Participants With Laboratory Values of Potential Clinical Relevance | White blood count (thou/mcl) (high) (N=625) | 3.8 Percentage of participants |
| Aripiprazole | Percentage of Participants With Laboratory Values of Potential Clinical Relevance | Alanine aminotransferase (IU/L) (N=626) | 1.1 Percentage of participants |
| Aripiprazole | Percentage of Participants With Laboratory Values of Potential Clinical Relevance | Aspartate aminotransferase (IU/L) (N=626) | 1.0 Percentage of participants |
| Aripiprazole | Percentage of Participants With Laboratory Values of Potential Clinical Relevance | Bilirubin (mg/dl) (high)(N=626) | 3.0 Percentage of participants |
| Aripiprazole | Percentage of Participants With Laboratory Values of Potential Clinical Relevance | Calcium (mg/dl) (low) (N=626) | 3.4 Percentage of participants |
| Aripiprazole | Percentage of Participants With Laboratory Values of Potential Clinical Relevance | Chloride (meq/l) (low) (N=626) | 0.5 Percentage of participants |
| Aripiprazole | Percentage of Participants With Laboratory Values of Potential Clinical Relevance | Chloride (meq/l) (high) (N=626) | 0.2 Percentage of participants |
| Aripiprazole | Percentage of Participants With Laboratory Values of Potential Clinical Relevance | Creatinine phosphokinase (IU/L) (N=626) | 14.9 Percentage of participants |
| Aripiprazole | Percentage of Participants With Laboratory Values of Potential Clinical Relevance | Creatinine (mg/dl) (N=617) | 0.5 Percentage of participants |
| Aripiprazole | Percentage of Participants With Laboratory Values of Potential Clinical Relevance | Glucose (mg/dl) (N=626) | 3.0 Percentage of participants |
| Aripiprazole | Percentage of Participants With Laboratory Values of Potential Clinical Relevance | Lactic dehydrogenase (IU/L) (N=626) | 0.2 Percentage of participants |
| Aripiprazole | Percentage of Participants With Laboratory Values of Potential Clinical Relevance | Potassium (meq/l) (low) (N=626) | 0.2 Percentage of participants |
| Aripiprazole | Percentage of Participants With Laboratory Values of Potential Clinical Relevance | Potassium (meq/l) (high) (N=626) | 5.3 Percentage of participants |
| Aripiprazole | Percentage of Participants With Laboratory Values of Potential Clinical Relevance | Sodium (meq/l) (high) (N=626) | 0.2 Percentage of participants |
| Aripiprazole | Percentage of Participants With Laboratory Values of Potential Clinical Relevance | Urea nitrogen (mg/dl) (N=626) | 0.8 Percentage of participants |
| Aripiprazole | Percentage of Participants With Laboratory Values of Potential Clinical Relevance | Uric acid (mg/dl) (N=626) | 1.0 Percentage of participants |
| Aripiprazole | Percentage of Participants With Laboratory Values of Potential Clinical Relevance | Eosinophils (%) (N=624) | 3.2 Percentage of participants |
| Aripiprazole | Percentage of Participants With Laboratory Values of Potential Clinical Relevance | Hematocrit (%) (N=623) | 2.7 Percentage of participants |
| Aripiprazole | Percentage of Participants With Laboratory Values of Potential Clinical Relevance | Hemoglobin (g/dl) (N=625) | 2.4 Percentage of participants |
| Aripiprazole | Percentage of Participants With Laboratory Values of Potential Clinical Relevance | Platelet count (per cubic mm) (low) (N=625) | 0.2 Percentage of participants |
| Aripiprazole | Percentage of Participants With Laboratory Values of Potential Clinical Relevance | Platelet count (per cubic mm) (high) (N=625) | 0.3 Percentage of participants |
| Aripiprazole | Percentage of Participants With Laboratory Values of Potential Clinical Relevance | White blood count (thou/mcl) (low) (N=625) | 1.1 Percentage of participants |
| Aripiprazole | Percentage of Participants With Laboratory Values of Potential Clinical Relevance | Glucose, urine (N=613) | 1.6 Percentage of participants |
| Aripiprazole | Percentage of Participants With Laboratory Values of Potential Clinical Relevance | Protein, urine (N=599) | 1.8 Percentage of participants |
Primary
Percentage of Participants With Vital Signs of Potential Clinical Relevance
The vital signs were one of the primary parameters to measure the safety and tolerability of individual participants. Incidence of TEAEs of potential clinical relevance included abnormal values in heart rate, systolic and diastolic blood pressure, respiratory rate and weight that were identified based on pre-defined criteria.
Time frame: Baseline, Weeks 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108 continuing every 12 weeks, Last Visit
Population: Safety Sample includes all randomized participants who receive at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aripiprazole | Percentage of Participants With Vital Signs of Potential Clinical Relevance | Heart rate sitting increase ≥15 bpm (N=625) | 0.5 percentage of participants |
| Aripiprazole | Percentage of Participants With Vital Signs of Potential Clinical Relevance | Systolic sitting BP increase ≥20 mmHg (N=627) | 0.8 percentage of participants |
| Aripiprazole | Percentage of Participants With Vital Signs of Potential Clinical Relevance | Systolic sitting BP decrease ≥20 mmHg (N=627) | 1.3 percentage of participants |
| Aripiprazole | Percentage of Participants With Vital Signs of Potential Clinical Relevance | Diastolic sitting BP increase ≥15mmHg (N=627) | 3.0 percentage of participants |
| Aripiprazole | Percentage of Participants With Vital Signs of Potential Clinical Relevance | Weight gain ≥7% (N=622) | 38.9 percentage of participants |
| Aripiprazole | Percentage of Participants With Vital Signs of Potential Clinical Relevance | Weight loss ≥7% (N=622) | 23.6 percentage of participants |