Schizophrenia
Conditions
Keywords
Schizophrenia
Brief summary
This will be a multicenter, 52 week, open label study to assess the safety and tolerability of oral OPC-34712 (1 to 6 mg) as monotherapy in adult patients with schizophrenia. The study will be conducted on an outpatient basis. Enrollment into the study will be drawn from eligible subjects who have completed participation in Study 331-07- 203 and who, in the investigator's judgment, would benefit from continued treatment with oral OPC-34712.
Interventions
DRUGOPC-34712
oral administered once daily
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 67 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects who participated in 331-07-203 and who, in the opinion of the investigator, have the potential to benefit from continued administration of OPC-34712 for the treatment of schizophrenia. 2. Outpatient status at last visit of Study 331-07-203.
Exclusion criteria
1. Sexually active males who are not practicing two different methods of birth control during the study and for 90 days after the last dose of study medication or who will not remain abstinent during the study and for 90 days after the last dose, or sexually active females of childbearing potential who are not practicing two different methods of birth control during the study and for 30 days after the last dose of study medication or who will not remain abstinent during the study and for 30 days after the last dose. If employing birth control, two of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pill, birth control depot injection, birth control implant, condom, or sponge with spermicide. 2. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving open-label OPC-34712. 3. Subjects who during the course of their participation in 331-07-203 were treated in violation of the protocol or who developed ANY
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) During First 6 Weeks. | From Baseline up to 6 weeks | AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. A treatment-emergent AE (TEAE) was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication. |
| Number of Participants With AEs in 52-Week Enrollers. | From Baseline up to 52 weeks | AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A SAE was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. A TEAE was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Personal and Social Performance Scale (PSP) Total Score. | Baseline, Week 1, 2, 6, 26, 52 and Last Visit | The PSP was a validated clinician-rated scale that measured personal and social functioning in four domains: socially useful activities (e.g, work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater's judgment that determined the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision. |
| Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit | The efficacy of study medication was rated for each participant using the CGI-I. The investigator rated the participants total improvement whether or not it was due to the drug treatment. All responses were compared to the participants condition at Screening/Baseline (i.e, Week 6 visit of Protocol NCT00905307). Response choices included: 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. |
| Change From Baseline in PANSS Positive Subscale Score. | Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit | The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS positive symptom score ranges from 7-49, with higher scores indicating more severe symptoms. |
| Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit | The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. The PANSS total score ranges from 30-210, with higher scores indicating more severe symptoms. |
| Percentage of Participants With a Positive Response Rate. | Last Visit | Response rate was defined as a reduction of ≥ 30% from Baseline in PANSS total score or CGI-I score of 1 (very much improved) or 2 (much improved) at the Last Visit. |
| Percentage of Participants Who Discontinued Due to Lack of Efficacy. | Last Visit | Discontinuation rate for the participants discontinued due to lack of efficacy were examined. |
| Change From Baseline in PANSS Negative Subscale Score. | Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit | The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In negative subscale the severity was rated for the following 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative symptom score ranges from 7-49, with higher scores indicating more severe symptoms. |
| Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit | The severity of illness for each participant were rated using the CGI-S. To perform this assessment, the investigator were to answer the following question: Considering your total clinical experience with this particular population, how mentally ill was the participant at that time? Response choices include: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. |
Countries
Bulgaria, Croatia, India, Philippines, Romania, Russia, Serbia, Slovakia, South Korea, Taiwan, Ukraine, United States
Participant flow
Recruitment details
The protocol was initially approved as a 6-week trial and later extended to a 52-week trial (Amendment 2). The trial enrolled 244 participants at 73 sites in 12 countries. Of the 244 participants, 28 were included in the 52-week enrollment population.
Pre-assignment details
Trial consisted of a screening visit, treatment phase and safety follow-up at 30 (± 2) days after the last dose of medication. Eligible participants for the trial were those who completed protocol NCT00905307 and who in the investigators judgment would benefit from the treatment.
Participants by arm
| Arm | Count |
|---|---|
| Prior Brexiprazole The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated. | 179 |
| Prior Placebo The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated. | 41 |
| Prior Apripiprazole The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated. | 24 |
| Total | 244 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 7 | 5 | 1 |
| Overall Study | Lack of Efficacy | 5 | 0 | 0 |
| Overall Study | Lost to Follow-up | 5 | 0 | 3 |
| Overall Study | Met withdrawal criteria | 4 | 0 | 0 |
| Overall Study | Physician Decision | 8 | 2 | 1 |
| Overall Study | Protocol deviation | 0 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 15 | 5 | 4 |
Baseline characteristics
| Characteristic | Prior Brexiprazole | Prior Placebo | Prior Apripiprazole | Total |
|---|---|---|---|---|
| Age, Continuous | 39.1 Years STANDARD_DEVIATION 10.1 | 41.4 Years STANDARD_DEVIATION 11.2 | 41.2 Years STANDARD_DEVIATION 12 | 39.7 Years STANDARD_DEVIATION 10.5 |
| Sex: Female, Male Female | 69 Participants | 17 Participants | 5 Participants | 91 Participants |
| Sex: Female, Male Male | 110 Participants | 24 Participants | 19 Participants | 153 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 31 / 178 | 10 / 41 | 4 / 23 |
| serious Total, serious adverse events | 4 / 178 | 6 / 41 | 1 / 23 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs) During First 6 Weeks.
AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. A treatment-emergent AE (TEAE) was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.
Time frame: From Baseline up to 6 weeks
Population: The safety dataset comprised of those participants who received at least one dose of open-label brexpiprazole and were enrolled in the 6-week study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior Brexpiprazole | Number of Participants With Adverse Events (AEs) During First 6 Weeks. | Participants with AEs | 79 Participants |
| Prior Brexpiprazole | Number of Participants With Adverse Events (AEs) During First 6 Weeks. | Participants with TEAEs | 78 Participants |
| Prior Brexpiprazole | Number of Participants With Adverse Events (AEs) During First 6 Weeks. | Participants with serious TEAEs | 4 Participants |
| Prior Brexpiprazole | Number of Participants With Adverse Events (AEs) During First 6 Weeks. | Participants with severe TEAEs | 2 Participants |
| Prior Placebo | Number of Participants With Adverse Events (AEs) During First 6 Weeks. | Participants with severe TEAEs | 3 Participants |
| Prior Placebo | Number of Participants With Adverse Events (AEs) During First 6 Weeks. | Participants with AEs | 19 Participants |
| Prior Placebo | Number of Participants With Adverse Events (AEs) During First 6 Weeks. | Participants with serious TEAEs | 6 Participants |
| Prior Placebo | Number of Participants With Adverse Events (AEs) During First 6 Weeks. | Participants with TEAEs | 19 Participants |
| Prior Aripiprazole | Number of Participants With Adverse Events (AEs) During First 6 Weeks. | Participants with severe TEAEs | 2 Participants |
| Prior Aripiprazole | Number of Participants With Adverse Events (AEs) During First 6 Weeks. | Participants with TEAEs | 7 Participants |
| Prior Aripiprazole | Number of Participants With Adverse Events (AEs) During First 6 Weeks. | Participants with serious TEAEs | 1 Participants |
| Prior Aripiprazole | Number of Participants With Adverse Events (AEs) During First 6 Weeks. | Participants with AEs | 7 Participants |
Primary
Number of Participants With AEs in 52-Week Enrollers.
AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the investigator. A SAE was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. A TEAE was defined as an AE that started after start of study medication or an AE that continued from baseline and that worsened, was serious, was study medication related, or resulted in death, discontinuation, interruption, or reduction of study medication.
Time frame: From Baseline up to 52 weeks
Population: Those participants who received at least one dose of open-label brexpiprazole and who were enrolled in the 52-week study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior Brexpiprazole | Number of Participants With AEs in 52-Week Enrollers. | Participants with AEs | 15 Participants |
| Prior Brexpiprazole | Number of Participants With AEs in 52-Week Enrollers. | Participants with TEAEs | 15 Participants |
| Prior Brexpiprazole | Number of Participants With AEs in 52-Week Enrollers. | Participants with serious TEAEs | 0 Participants |
| Prior Brexpiprazole | Number of Participants With AEs in 52-Week Enrollers. | Participants with severe TEAEs | 0 Participants |
| Prior Placebo | Number of Participants With AEs in 52-Week Enrollers. | Participants with severe TEAEs | 1 Participants |
| Prior Placebo | Number of Participants With AEs in 52-Week Enrollers. | Participants with AEs | 4 Participants |
| Prior Placebo | Number of Participants With AEs in 52-Week Enrollers. | Participants with serious TEAEs | 0 Participants |
| Prior Placebo | Number of Participants With AEs in 52-Week Enrollers. | Participants with TEAEs | 4 Participants |
| Prior Aripiprazole | Number of Participants With AEs in 52-Week Enrollers. | Participants with severe TEAEs | 0 Participants |
| Prior Aripiprazole | Number of Participants With AEs in 52-Week Enrollers. | Participants with TEAEs | 2 Participants |
| Prior Aripiprazole | Number of Participants With AEs in 52-Week Enrollers. | Participants with serious TEAEs | 0 Participants |
| Prior Aripiprazole | Number of Participants With AEs in 52-Week Enrollers. | Participants with AEs | 2 Participants |
Secondary
Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score.
The severity of illness for each participant were rated using the CGI-S. To perform this assessment, the investigator were to answer the following question: Considering your total clinical experience with this particular population, how mentally ill was the participant at that time? Response choices include: 0 = not assessed; 1 = normal, not at all ill; 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, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit
Population: The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prior Brexpiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 38 (N= 17, 3, 2) | -0.71 Units on a scale | Standard Deviation 0.85 |
| Prior Brexpiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 8 (N= 20, 6, 2) | -0.20 Units on a scale | Standard Deviation 0.77 |
| Prior Brexpiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 2 (N= 164, 40, 21) | -0.12 Units on a scale | Standard Deviation 0.63 |
| Prior Brexpiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 32 (N= 18, 5, 2) | -0.78 Units on a scale | Standard Deviation 0.81 |
| Prior Brexpiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 14 (N= 20, 6, 2) | -0.40 Units on a scale | Standard Deviation 0.68 |
| Prior Brexpiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 1 (N= 167, 40, 23) | -0.08 Units on a scale | Standard Deviation 0.47 |
| Prior Brexpiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 26 (N= 19, 5, 2) | -0.63 Units on a scale | Standard Deviation 0.9 |
| Prior Brexpiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 20 (N= 20, 5, 2) | -0.55 Units on a scale | Standard Deviation 0.76 |
| Prior Brexpiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 44 (N= 17, 2, 2) | -0.82 Units on a scale | Standard Deviation 0.81 |
| Prior Brexpiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 4 (N= 148, 34, 18) | -0.25 Units on a scale | Standard Deviation 0.64 |
| Prior Brexpiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Last visit (N= 176, 41, 23) | -0.33 Units on a scale | Standard Deviation 0.83 |
| Prior Brexpiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Day 4 (N= 169, 36, 22) | 0.02 Units on a scale | Standard Deviation 0.51 |
| Prior Brexpiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 6 (N= 139, 31, 15) | -0.40 Units on a scale | Standard Deviation 0.66 |
| Prior Brexpiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 52 (N= 16, 2, 2) | -0.88 Units on a scale | Standard Deviation 0.81 |
| Prior Placebo | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 38 (N= 17, 3, 2) | 0.00 Units on a scale | Standard Deviation 0 |
| Prior Placebo | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Day 4 (N= 169, 36, 22) | -0.03 Units on a scale | Standard Deviation 0.29 |
| Prior Placebo | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 1 (N= 167, 40, 23) | -0.05 Units on a scale | Standard Deviation 0.6 |
| Prior Placebo | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 2 (N= 164, 40, 21) | -0.18 Units on a scale | Standard Deviation 0.71 |
| Prior Placebo | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 4 (N= 148, 34, 18) | -0.24 Units on a scale | Standard Deviation 0.82 |
| Prior Placebo | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 6 (N= 139, 31, 15) | -0.35 Units on a scale | Standard Deviation 0.8 |
| Prior Placebo | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 8 (N= 20, 6, 2) | 0.17 Units on a scale | Standard Deviation 0.41 |
| Prior Placebo | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 14 (N= 20, 6, 2) | 0.83 Units on a scale | Standard Deviation 1.6 |
| Prior Placebo | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 20 (N= 20, 5, 2) | 0.20 Units on a scale | Standard Deviation 0.45 |
| Prior Placebo | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 26 (N= 19, 5, 2) | 0.00 Units on a scale | Standard Deviation 0.71 |
| Prior Placebo | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 32 (N= 18, 5, 2) | 0.20 Units on a scale | Standard Deviation 1.1 |
| Prior Placebo | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 44 (N= 17, 2, 2) | 0.00 Units on a scale | Standard Deviation 0 |
| Prior Placebo | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 52 (N= 16, 2, 2) | 0.00 Units on a scale | Standard Deviation 0 |
| Prior Placebo | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Last visit (N= 176, 41, 23) | -0.15 Units on a scale | Standard Deviation 1.2 |
| Prior Aripiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 52 (N= 16, 2, 2) | -0.50 Units on a scale | Standard Deviation 0.71 |
| Prior Aripiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 32 (N= 18, 5, 2) | -0.50 Units on a scale | Standard Deviation 0.71 |
| Prior Aripiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 6 (N= 139, 31, 15) | -0.33 Units on a scale | Standard Deviation 0.49 |
| Prior Aripiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 4 (N= 148, 34, 18) | -0.22 Units on a scale | Standard Deviation 0.43 |
| Prior Aripiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 38 (N= 17, 3, 2) | -0.50 Units on a scale | Standard Deviation 0.71 |
| Prior Aripiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 2 (N= 164, 40, 21) | 0.00 Units on a scale | Standard Deviation 0.32 |
| Prior Aripiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Day 4 (N= 169, 36, 22) | 0.05 Units on a scale | Standard Deviation 0.38 |
| Prior Aripiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 44 (N= 17, 2, 2) | -0.50 Units on a scale | Standard Deviation 0.71 |
| Prior Aripiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 1 (N= 167, 40, 23) | -0.04 Units on a scale | Standard Deviation 0.37 |
| Prior Aripiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 20 (N= 20, 5, 2) | 0.00 Units on a scale | Standard Deviation 0 |
| Prior Aripiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 14 (N= 20, 6, 2) | 0.50 Units on a scale | Standard Deviation 0.71 |
| Prior Aripiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Last visit (N= 176, 41, 23) | -0.30 Units on a scale | Standard Deviation 0.56 |
| Prior Aripiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 26 (N= 19, 5, 2) | 0.00 Units on a scale | Standard Deviation 0 |
| Prior Aripiprazole | Change From Baseline in Clinical Global Impression- Severity of Illness Scale (CGI-S) Score. | Week 8 (N= 20, 6, 2) | 0.00 Units on a scale | Standard Deviation 0 |
Secondary
Change From Baseline in PANSS Negative Subscale Score.
The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In negative subscale the severity was rated for the following 7 negative symptom constructs: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. The PANSS negative symptom score ranges from 7-49, with higher scores indicating more severe symptoms.
Time frame: Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit
Population: The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prior Brexpiprazole | Change From Baseline in PANSS Negative Subscale Score. | Week 1 (N= 167, 40, 23) | -0.47 Units on a scale | Standard Deviation 2.15 |
| Prior Brexpiprazole | Change From Baseline in PANSS Negative Subscale Score. | Week 38 (N= 17, 3, 2) | -3.94 Units on a scale | Standard Deviation 3.93 |
| Prior Brexpiprazole | Change From Baseline in PANSS Negative Subscale Score. | Week 6 (N= 138, 31, 15) | -1.70 Units on a scale | Standard Deviation 3.04 |
| Prior Brexpiprazole | Change From Baseline in PANSS Negative Subscale Score. | Week 44 (N= 17, 2, 2) | -4.18 Units on a scale | Standard Deviation 3.61 |
| Prior Brexpiprazole | Change From Baseline in PANSS Negative Subscale Score. | Week 32 (N= 18, 5, 2) | -4.00 Units on a scale | Standard Deviation 4.41 |
| Prior Brexpiprazole | Change From Baseline in PANSS Negative Subscale Score. | Week 14 (N= 20, 6, 2) | -2.85 Units on a scale | Standard Deviation 3.15 |
| Prior Brexpiprazole | Change From Baseline in PANSS Negative Subscale Score. | Week 4 (N= 148, 34, 18) | -1.03 Units on a scale | Standard Deviation 2.99 |
| Prior Brexpiprazole | Change From Baseline in PANSS Negative Subscale Score. | Week 26 (N= 19, 5, 2) | -3.74 Units on a scale | Standard Deviation 3.43 |
| Prior Brexpiprazole | Change From Baseline in PANSS Negative Subscale Score. | Week 20 (N= 20, 5, 2) | -3.00 Units on a scale | Standard Deviation 3.04 |
| Prior Brexpiprazole | Change From Baseline in PANSS Negative Subscale Score. | Last visit (N= 176, 41, 23) | -1.53 Units on a scale | Standard Deviation 3.28 |
| Prior Brexpiprazole | Change From Baseline in PANSS Negative Subscale Score. | Week 8 (N= 20, 6, 2) | -2.55 Units on a scale | Standard Deviation 2.68 |
| Prior Brexpiprazole | Change From Baseline in PANSS Negative Subscale Score. | Week 52 (N= 16, 2, 2) | -4.00 Units on a scale | Standard Deviation 3.58 |
| Prior Brexpiprazole | Change From Baseline in PANSS Negative Subscale Score. | Day 4 (N= 169, 36, 22) | -0.01 Units on a scale | Standard Deviation 1.99 |
| Prior Brexpiprazole | Change From Baseline in PANSS Negative Subscale Score. | Week 2 (N= 165, 40, 21) | -0.68 Units on a scale | Standard Deviation 2.61 |
| Prior Placebo | Change From Baseline in PANSS Negative Subscale Score. | Week 38 (N= 17, 3, 2) | -0.67 Units on a scale | Standard Deviation 2.08 |
| Prior Placebo | Change From Baseline in PANSS Negative Subscale Score. | Week 1 (N= 167, 40, 23) | -0.40 Units on a scale | Standard Deviation 2.58 |
| Prior Placebo | Change From Baseline in PANSS Negative Subscale Score. | Week 2 (N= 165, 40, 21) | -0.83 Units on a scale | Standard Deviation 2.32 |
| Prior Placebo | Change From Baseline in PANSS Negative Subscale Score. | Week 4 (N= 148, 34, 18) | -1.35 Units on a scale | Standard Deviation 3.02 |
| Prior Placebo | Change From Baseline in PANSS Negative Subscale Score. | Week 8 (N= 20, 6, 2) | -1.00 Units on a scale | Standard Deviation 2 |
| Prior Placebo | Change From Baseline in PANSS Negative Subscale Score. | Week 26 (N= 19, 5, 2) | -1.20 Units on a scale | Standard Deviation 1.48 |
| Prior Placebo | Change From Baseline in PANSS Negative Subscale Score. | Day 4 (N= 169, 36, 22) | -0.25 Units on a scale | Standard Deviation 1 |
| Prior Placebo | Change From Baseline in PANSS Negative Subscale Score. | Week 6 (N= 138, 31, 15) | -1.97 Units on a scale | Standard Deviation 2.7 |
| Prior Placebo | Change From Baseline in PANSS Negative Subscale Score. | Week 14 (N= 20, 6, 2) | 1.17 Units on a scale | Standard Deviation 7.05 |
| Prior Placebo | Change From Baseline in PANSS Negative Subscale Score. | Week 20 (N= 20, 5, 2) | -0.60 Units on a scale | Standard Deviation 1.14 |
| Prior Placebo | Change From Baseline in PANSS Negative Subscale Score. | Week 32 (N= 18, 5, 2) | -1.00 Units on a scale | Standard Deviation 1.87 |
| Prior Placebo | Change From Baseline in PANSS Negative Subscale Score. | Week 44 (N= 17, 2, 2) | -1.00 Units on a scale | Standard Deviation 2.83 |
| Prior Placebo | Change From Baseline in PANSS Negative Subscale Score. | Week 52 (N= 16, 2, 2) | -1.00 Units on a scale | Standard Deviation 2.83 |
| Prior Placebo | Change From Baseline in PANSS Negative Subscale Score. | Last visit (N= 176, 41, 23) | -1.10 Units on a scale | Standard Deviation 3.85 |
| Prior Aripiprazole | Change From Baseline in PANSS Negative Subscale Score. | Week 52 (N= 16, 2, 2) | -2.00 Units on a scale | Standard Deviation 1.41 |
| Prior Aripiprazole | Change From Baseline in PANSS Negative Subscale Score. | Week 32 (N= 18, 5, 2) | -2.50 Units on a scale | Standard Deviation 3.54 |
| Prior Aripiprazole | Change From Baseline in PANSS Negative Subscale Score. | Week 4 (N= 148, 34, 18) | -1.94 Units on a scale | Standard Deviation 2.48 |
| Prior Aripiprazole | Change From Baseline in PANSS Negative Subscale Score. | Week 8 (N= 20, 6, 2) | -1.00 Units on a scale | Standard Deviation 1.41 |
| Prior Aripiprazole | Change From Baseline in PANSS Negative Subscale Score. | Week 38 (N= 17, 3, 2) | -2.50 Units on a scale | Standard Deviation 3.54 |
| Prior Aripiprazole | Change From Baseline in PANSS Negative Subscale Score. | Week 2 (N= 165, 40, 21) | -1.19 Units on a scale | Standard Deviation 2.52 |
| Prior Aripiprazole | Change From Baseline in PANSS Negative Subscale Score. | Day 4 (N= 169, 36, 22) | -0.86 Units on a scale | Standard Deviation 2.12 |
| Prior Aripiprazole | Change From Baseline in PANSS Negative Subscale Score. | Week 44 (N= 17, 2, 2) | -2.50 Units on a scale | Standard Deviation 3.54 |
| Prior Aripiprazole | Change From Baseline in PANSS Negative Subscale Score. | Week 1 (N= 167, 40, 23) | -0.87 Units on a scale | Standard Deviation 2.44 |
| Prior Aripiprazole | Change From Baseline in PANSS Negative Subscale Score. | Last visit (N= 176, 41, 23) | -2.09 Units on a scale | Standard Deviation 2.59 |
| Prior Aripiprazole | Change From Baseline in PANSS Negative Subscale Score. | Week 20 (N= 20, 5, 2) | -2.00 Units on a scale | Standard Deviation 2.83 |
| Prior Aripiprazole | Change From Baseline in PANSS Negative Subscale Score. | Week 14 (N= 20, 6, 2) | -1.50 Units on a scale | Standard Deviation 2.12 |
| Prior Aripiprazole | Change From Baseline in PANSS Negative Subscale Score. | Week 26 (N= 19, 5, 2) | -2.50 Units on a scale | Standard Deviation 2.12 |
| Prior Aripiprazole | Change From Baseline in PANSS Negative Subscale Score. | Week 6 (N= 138, 31, 15) | -2.40 Units on a scale | Standard Deviation 2.61 |
Secondary
Change From Baseline in PANSS Positive Subscale Score.
The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. The PANSS positive symptom score ranges from 7-49, with higher scores indicating more severe symptoms.
Time frame: Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit
Population: The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prior Brexpiprazole | Change From Baseline in PANSS Positive Subscale Score. | Week 52 (N= 16, 2, 2) | -3.63 Units on a scale | Standard Deviation 3.74 |
| Prior Brexpiprazole | Change From Baseline in PANSS Positive Subscale Score. | Week 32 (N= 18, 5, 2) | -3.83 Units on a scale | Standard Deviation 3.54 |
| Prior Brexpiprazole | Change From Baseline in PANSS Positive Subscale Score. | Week 2 (N= 165, 40, 21) | -1.09 Units on a scale | Standard Deviation 2.92 |
| Prior Brexpiprazole | Change From Baseline in PANSS Positive Subscale Score. | Last visit (N= 176, 41, 23) | -1.74 Units on a scale | Standard Deviation 3.86 |
| Prior Brexpiprazole | Change From Baseline in PANSS Positive Subscale Score. | Week 26 (N= 19, 5, 2) | -3.42 Units on a scale | Standard Deviation 2.99 |
| Prior Brexpiprazole | Change From Baseline in PANSS Positive Subscale Score. | Week 1 (N= 167, 40, 23) | -0.66 Units on a scale | Standard Deviation 1.91 |
| Prior Brexpiprazole | Change From Baseline in PANSS Positive Subscale Score. | Day 4 (N= 169, 36, 22) | -0.04 Units on a scale | Standard Deviation 2.06 |
| Prior Brexpiprazole | Change From Baseline in PANSS Positive Subscale Score. | Week 8 (N= 20, 6, 2) | -2.10 Units on a scale | Standard Deviation 3.02 |
| Prior Brexpiprazole | Change From Baseline in PANSS Positive Subscale Score. | Week 38 (N= 17, 3, 2) | -3.71 Units on a scale | Standard Deviation 4.1 |
| Prior Brexpiprazole | Change From Baseline in PANSS Positive Subscale Score. | Week 20 (20, 5, 2) | -2.60 Units on a scale | Standard Deviation 3.49 |
| Prior Brexpiprazole | Change From Baseline in PANSS Positive Subscale Score. | Week 6 (N= 138, 31, 15) | -2.36 Units on a scale | Standard Deviation 3.21 |
| Prior Brexpiprazole | Change From Baseline in PANSS Positive Subscale Score. | Week 44 (N= 17, 2, 2) | -4.24 Units on a scale | Standard Deviation 3.53 |
| Prior Brexpiprazole | Change From Baseline in PANSS Positive Subscale Score. | Week 14 (20, 6, 2) | -2.80 Units on a scale | Standard Deviation 2.65 |
| Prior Brexpiprazole | Change From Baseline in PANSS Positive Subscale Score. | Week 4 (N= 148, 34, 18) | -1.53 Units on a scale | Standard Deviation 2.96 |
| Prior Placebo | Change From Baseline in PANSS Positive Subscale Score. | Week 8 (N= 20, 6, 2) | -1.67 Units on a scale | Standard Deviation 2.34 |
| Prior Placebo | Change From Baseline in PANSS Positive Subscale Score. | Week 26 (N= 19, 5, 2) | -2.60 Units on a scale | Standard Deviation 2.61 |
| Prior Placebo | Change From Baseline in PANSS Positive Subscale Score. | Week 32 (N= 18, 5, 2) | -1.00 Units on a scale | Standard Deviation 4.85 |
| Prior Placebo | Change From Baseline in PANSS Positive Subscale Score. | Week 38 (N= 17, 3, 2) | -2.67 Units on a scale | Standard Deviation 2.52 |
| Prior Placebo | Change From Baseline in PANSS Positive Subscale Score. | Week 44 (N= 17, 2, 2) | -1.50 Units on a scale | Standard Deviation 2.12 |
| Prior Placebo | Change From Baseline in PANSS Positive Subscale Score. | Week 52 (N= 16, 2, 2) | -1.50 Units on a scale | Standard Deviation 2.12 |
| Prior Placebo | Change From Baseline in PANSS Positive Subscale Score. | Last visit (N= 176, 41, 23) | -0.22 Units on a scale | Standard Deviation 6.04 |
| Prior Placebo | Change From Baseline in PANSS Positive Subscale Score. | Day 4 (N= 169, 36, 22) | -0.50 Units on a scale | Standard Deviation 1.36 |
| Prior Placebo | Change From Baseline in PANSS Positive Subscale Score. | Week 1 (N= 167, 40, 23) | -0.25 Units on a scale | Standard Deviation 2.72 |
| Prior Placebo | Change From Baseline in PANSS Positive Subscale Score. | Week 2 (N= 165, 40, 21) | -0.70 Units on a scale | Standard Deviation 3.75 |
| Prior Placebo | Change From Baseline in PANSS Positive Subscale Score. | Week 4 (N= 148, 34, 18) | -1.06 Units on a scale | Standard Deviation 3.95 |
| Prior Placebo | Change From Baseline in PANSS Positive Subscale Score. | Week 6 (N= 138, 31, 15) | -2.03 Units on a scale | Standard Deviation 3.06 |
| Prior Placebo | Change From Baseline in PANSS Positive Subscale Score. | Week 20 (20, 5, 2) | -1.80 Units on a scale | Standard Deviation 2.39 |
| Prior Placebo | Change From Baseline in PANSS Positive Subscale Score. | Week 14 (20, 6, 2) | 2.17 Units on a scale | Standard Deviation 9.04 |
| Prior Aripiprazole | Change From Baseline in PANSS Positive Subscale Score. | Week 2 (N= 165, 40, 21) | -0.05 Units on a scale | Standard Deviation 2.84 |
| Prior Aripiprazole | Change From Baseline in PANSS Positive Subscale Score. | Week 44 (N= 17, 2, 2) | -4.00 Units on a scale | Standard Deviation 1.41 |
| Prior Aripiprazole | Change From Baseline in PANSS Positive Subscale Score. | Week 26 (N= 19, 5, 2) | -3.00 Units on a scale | Standard Deviation 1.41 |
| Prior Aripiprazole | Change From Baseline in PANSS Positive Subscale Score. | Week 4 (N= 148, 34, 18) | -1.11 Units on a scale | Standard Deviation 2.08 |
| Prior Aripiprazole | Change From Baseline in PANSS Positive Subscale Score. | Week 38 (N= 17, 3, 2) | -3.00 Units on a scale | Standard Deviation 0 |
| Prior Aripiprazole | Change From Baseline in PANSS Positive Subscale Score. | Week 20 (20, 5, 2) | 0.00 Units on a scale | Standard Deviation 4.24 |
| Prior Aripiprazole | Change From Baseline in PANSS Positive Subscale Score. | Week 6 (N= 138, 31, 15) | -1.87 Units on a scale | Standard Deviation 2.39 |
| Prior Aripiprazole | Change From Baseline in PANSS Positive Subscale Score. | Week 32 (N= 18, 5, 2) | -5.00 Units on a scale | Standard Deviation 1.41 |
| Prior Aripiprazole | Change From Baseline in PANSS Positive Subscale Score. | Day 4 (N= 169, 36, 22) | 0.09 Units on a scale | Standard Deviation 2.24 |
| Prior Aripiprazole | Change From Baseline in PANSS Positive Subscale Score. | Last visit (N= 176, 41, 23) | -1.43 Units on a scale | Standard Deviation 2.87 |
| Prior Aripiprazole | Change From Baseline in PANSS Positive Subscale Score. | Week 14 (20, 6, 2) | 1.00 Units on a scale | Standard Deviation 4.24 |
| Prior Aripiprazole | Change From Baseline in PANSS Positive Subscale Score. | Week 1 (N= 167, 40, 23) | -0.78 Units on a scale | Standard Deviation 2.76 |
| Prior Aripiprazole | Change From Baseline in PANSS Positive Subscale Score. | Week 52 (N= 16, 2, 2) | -4.50 Units on a scale | Standard Deviation 3.54 |
| Prior Aripiprazole | Change From Baseline in PANSS Positive Subscale Score. | Week 8 (N= 20, 6, 2) | -2.50 Units on a scale | Standard Deviation 2.12 |
Secondary
Change From Baseline in Personal and Social Performance Scale (PSP) Total Score.
The PSP was a validated clinician-rated scale that measured personal and social functioning in four domains: socially useful activities (e.g, work and study), personal and social relationships, self-care, and disturbing and aggressive behaviors. Impairment in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval, and the rater's judgment that determined the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented manifest disabilities of various degrees and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.
Time frame: Baseline, Week 1, 2, 6, 26, 52 and Last Visit
Population: The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Prior Brexpiprazole | Change From Baseline in Personal and Social Performance Scale (PSP) Total Score. | Week 1 (N= 5, 1, 1) | -2.00 Units on a scale | Full Range 4.82 |
| Prior Brexpiprazole | Change From Baseline in Personal and Social Performance Scale (PSP) Total Score. | Week 2 (N= 163, 40, 21) | 1.00 Units on a scale | Full Range 7.11 |
| Prior Brexpiprazole | Change From Baseline in Personal and Social Performance Scale (PSP) Total Score. | Week 6 (N= 139, 31, 15) | 5.00 Units on a scale | Full Range 9.34 |
| Prior Brexpiprazole | Change From Baseline in Personal and Social Performance Scale (PSP) Total Score. | Week 26 (N= 19, 5, 2) | 6.00 Units on a scale | Full Range 5.35 |
| Prior Brexpiprazole | Change From Baseline in Personal and Social Performance Scale (PSP) Total Score. | Week 52 (N= 16, 2, 2) | 13.00 Units on a scale | Full Range 7.31 |
| Prior Brexpiprazole | Change From Baseline in Personal and Social Performance Scale (PSP) Total Score. | Last visit (N= 171, 41, 22) | 4.00 Units on a scale | Full Range 10.28 |
| Prior Placebo | Change From Baseline in Personal and Social Performance Scale (PSP) Total Score. | Last visit (N= 171, 41, 22) | 5.00 Units on a scale | Full Range 15.1 |
| Prior Placebo | Change From Baseline in Personal and Social Performance Scale (PSP) Total Score. | Week 1 (N= 5, 1, 1) | -21.00 Units on a scale | Full Range 0 |
| Prior Placebo | Change From Baseline in Personal and Social Performance Scale (PSP) Total Score. | Week 26 (N= 19, 5, 2) | 12.00 Units on a scale | Full Range 8.07 |
| Prior Placebo | Change From Baseline in Personal and Social Performance Scale (PSP) Total Score. | Week 52 (N= 16, 2, 2) | 13.00 Units on a scale | Full Range 1.41 |
| Prior Placebo | Change From Baseline in Personal and Social Performance Scale (PSP) Total Score. | Week 2 (N= 163, 40, 21) | 1.50 Units on a scale | Full Range 8.16 |
| Prior Placebo | Change From Baseline in Personal and Social Performance Scale (PSP) Total Score. | Week 6 (N= 139, 31, 15) | 6.00 Units on a scale | Full Range 10.86 |
| Prior Aripiprazole | Change From Baseline in Personal and Social Performance Scale (PSP) Total Score. | Week 2 (N= 163, 40, 21) | 0.00 Units on a scale | Full Range 0 |
| Prior Aripiprazole | Change From Baseline in Personal and Social Performance Scale (PSP) Total Score. | Week 6 (N= 139, 31, 15) | 1.00 Units on a scale | Full Range 5.96 |
| Prior Aripiprazole | Change From Baseline in Personal and Social Performance Scale (PSP) Total Score. | Last visit (N= 171, 41, 22) | 1.00 Units on a scale | Full Range 5.32 |
| Prior Aripiprazole | Change From Baseline in Personal and Social Performance Scale (PSP) Total Score. | Week 26 (N= 19, 5, 2) | 2.50 Units on a scale | Full Range 3.54 |
| Prior Aripiprazole | Change From Baseline in Personal and Social Performance Scale (PSP) Total Score. | Week 1 (N= 5, 1, 1) | -5.00 Units on a scale | Full Range 0 |
| Prior Aripiprazole | Change From Baseline in Personal and Social Performance Scale (PSP) Total Score. | Week 52 (N= 16, 2, 2) | 0.50 Units on a scale | Full Range 0.71 |
Secondary
Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit.
The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. The PANSS total score ranges from 30-210, with higher scores indicating more severe symptoms.
Time frame: Baseline, Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit
Population: The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prior Brexpiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 38 (N= 17, 3, 2) | -13.24 Units on a scale | Standard Deviation 10.97 |
| Prior Brexpiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 8 (N=20, 6, 2) | -8.80 Units on a scale | Standard Deviation 8.69 |
| Prior Brexpiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 2 (N= 165, 40, 21) | -2.95 Units on a scale | Standard Deviation 8.8 |
| Prior Brexpiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 32 (N= 18, 5, 2) | -14.67 Units on a scale | Standard Deviation 10.94 |
| Prior Brexpiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 14 (N=20, 6, 2) | -9.85 Units on a scale | Standard Deviation 8.09 |
| Prior Brexpiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 1 (N= 167, 40, 23) | -2.03 Units on a scale | Standard Deviation 5.49 |
| Prior Brexpiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 26 (N= 19, 5, 2) | -12.89 Units on a scale | Standard Deviation 9.34 |
| Prior Brexpiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 20 (N= 20, 5, 2) | -10.20 Units on a scale | Standard Deviation 9.12 |
| Prior Brexpiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 44 (N= 17, 2, 2) | -16.00 Units on a scale | Standard Deviation 10.28 |
| Prior Brexpiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 4 (N=148, 34, 18) | -4.65 Units on a scale | Standard Deviation 8.59 |
| Prior Brexpiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Last visit (N= 176, 41, 23) | -5.99 Units on a scale | Standard Deviation 11.25 |
| Prior Brexpiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Day 4 (N= 169, 36, 22) | 0.11 Units on a scale | Standard Deviation 5.86 |
| Prior Brexpiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 6 (N= 138, 31, 15) | -7.51 Units on a scale | Standard Deviation 8.82 |
| Prior Brexpiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 52 (N= 16, 2, 2) | -15.00 Units on a scale | Standard Deviation 10.06 |
| Prior Placebo | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 38 (N= 17, 3, 2) | -4.67 Units on a scale | Standard Deviation 10.21 |
| Prior Placebo | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Day 4 (N= 169, 36, 22) | -1.25 Units on a scale | Standard Deviation 3.97 |
| Prior Placebo | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 1 (N= 167, 40, 23) | -1.53 Units on a scale | Standard Deviation 7.95 |
| Prior Placebo | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 2 (N= 165, 40, 21) | -3.43 Units on a scale | Standard Deviation 10.68 |
| Prior Placebo | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 4 (N=148, 34, 18) | -4.71 Units on a scale | Standard Deviation 12.85 |
| Prior Placebo | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 6 (N= 138, 31, 15) | -7.87 Units on a scale | Standard Deviation 10.26 |
| Prior Placebo | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 8 (N=20, 6, 2) | -5.17 Units on a scale | Standard Deviation 7.55 |
| Prior Placebo | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 14 (N=20, 6, 2) | 6.83 Units on a scale | Standard Deviation 28.29 |
| Prior Placebo | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 20 (N= 20, 5, 2) | -4.60 Units on a scale | Standard Deviation 10.71 |
| Prior Placebo | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 26 (N= 19, 5, 2) | -5.80 Units on a scale | Standard Deviation 11.56 |
| Prior Placebo | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 32 (N= 18, 5, 2) | -3.00 Units on a scale | Standard Deviation 16.9 |
| Prior Placebo | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 44 (N= 17, 2, 2) | -4.50 Units on a scale | Standard Deviation 12.02 |
| Prior Placebo | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 52 (N= 16, 2, 2) | -5.50 Units on a scale | Standard Deviation 13.44 |
| Prior Placebo | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Last visit (N= 176, 41, 23) | -2.32 Units on a scale | Standard Deviation 18.97 |
| Prior Aripiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 52 (N= 16, 2, 2) | -11.00 Units on a scale | Standard Deviation 7.07 |
| Prior Aripiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 32 (N= 18, 5, 2) | -16.00 Units on a scale | Standard Deviation 0 |
| Prior Aripiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 6 (N= 138, 31, 15) | -7.47 Units on a scale | Standard Deviation 7.22 |
| Prior Aripiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 4 (N=148, 34, 18) | -5.39 Units on a scale | Standard Deviation 6.3 |
| Prior Aripiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 38 (N= 17, 3, 2) | -13.00 Units on a scale | Standard Deviation 0 |
| Prior Aripiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 2 (N= 165, 40, 21) | -1.86 Units on a scale | Standard Deviation 6.04 |
| Prior Aripiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Day 4 (N= 169, 36, 22) | -1.50 Units on a scale | Standard Deviation 4.97 |
| Prior Aripiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 44 (N= 17, 2, 2) | -11.50 Units on a scale | Standard Deviation 2.12 |
| Prior Aripiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 1 (N= 167, 40, 23) | -1.91 Units on a scale | Standard Deviation 6.22 |
| Prior Aripiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 20 (N= 20, 5, 2) | -6.50 Units on a scale | Standard Deviation 10.61 |
| Prior Aripiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 14 (N=20, 6, 2) | -3.50 Units on a scale | Standard Deviation 12.02 |
| Prior Aripiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Last visit (N= 176, 41, 23) | -5.96 Units on a scale | Standard Deviation 8.27 |
| Prior Aripiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 26 (N= 19, 5, 2) | -10.50 Units on a scale | Standard Deviation 7.78 |
| Prior Aripiprazole | Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) by Study Week and at the Last Visit. | Week 8 (N=20, 6, 2) | -10.00 Units on a scale | Standard Deviation 1.41 |
Secondary
Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score.
The efficacy of study medication was rated for each participant using the CGI-I. The investigator rated the participants total improvement whether or not it was due to the drug treatment. All responses were compared to the participants condition at Screening/Baseline (i.e, Week 6 visit of Protocol NCT00905307). Response choices included: 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: Day 4, Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and Last Visit
Population: The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prior Brexpiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 38 (N= 17, 3, 2) | 2.53 Units on a scale | Standard Deviation 0.87 |
| Prior Brexpiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 8 (N= 20, 6, 2) | 2.80 Units on a scale | Standard Deviation 0.95 |
| Prior Brexpiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 2 (N= 164, 40, 21) | 3.41 Units on a scale | Standard Deviation 1.1 |
| Prior Brexpiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 32 (N= 18, 5, 2) | 2.56 Units on a scale | Standard Deviation 0.78 |
| Prior Brexpiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 14 (N= 20, 6, 2) | 2.75 Units on a scale | Standard Deviation 0.85 |
| Prior Brexpiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 1 (N= 167, 40, 23) | 3.51 Units on a scale | Standard Deviation 0.89 |
| Prior Brexpiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 26 (N= 19, 5, 2) | 2.74 Units on a scale | Standard Deviation 0.93 |
| Prior Brexpiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 20 (N= 20, 5, 2) | 2.70 Units on a scale | Standard Deviation 1.03 |
| Prior Brexpiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 44 (N= 17, 2, 2) | 2.35 Units on a scale | Standard Deviation 0.79 |
| Prior Brexpiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 4 (N= 148, 34, 18) | 3.14 Units on a scale | Standard Deviation 1.04 |
| Prior Brexpiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Last visit (N= 176, 41, 23) | 3.04 Units on a scale | Standard Deviation 1.14 |
| Prior Brexpiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Day 4 (N= 169, 36, 22) | 3.70 Units on a scale | Standard Deviation 0.87 |
| Prior Brexpiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 6 (N= 139, 31, 15) | 2.86 Units on a scale | Standard Deviation 0.99 |
| Prior Brexpiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 52 (N= 16, 2, 2) | 2.31 Units on a scale | Standard Deviation 0.79 |
| Prior Placebo | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 38 (N= 17, 3, 2) | 2.67 Units on a scale | Standard Deviation 1.15 |
| Prior Placebo | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Day 4 (N= 169, 36, 22) | 3.56 Units on a scale | Standard Deviation 0.88 |
| Prior Placebo | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 1 (N= 167, 40, 23) | 3.73 Units on a scale | Standard Deviation 0.93 |
| Prior Placebo | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 2 (N= 164, 40, 21) | 3.45 Units on a scale | Standard Deviation 1.28 |
| Prior Placebo | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 4 (N= 148, 34, 18) | 3.26 Units on a scale | Standard Deviation 1.21 |
| Prior Placebo | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 6 (N= 139, 31, 15) | 3.03 Units on a scale | Standard Deviation 1.28 |
| Prior Placebo | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 8 (N= 20, 6, 2) | 3.50 Units on a scale | Standard Deviation 1.22 |
| Prior Placebo | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 14 (N= 20, 6, 2) | 3.83 Units on a scale | Standard Deviation 1.6 |
| Prior Placebo | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 20 (N= 20, 5, 2) | 3.20 Units on a scale | Standard Deviation 1.3 |
| Prior Placebo | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 26 (N= 19, 5, 2) | 3.00 Units on a scale | Standard Deviation 1.41 |
| Prior Placebo | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 32 (N= 18, 5, 2) | 3.20 Units on a scale | Standard Deviation 1.79 |
| Prior Placebo | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 44 (N= 17, 2, 2) | 3.00 Units on a scale | Standard Deviation 1.41 |
| Prior Placebo | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 52 (N= 16, 2, 2) | 3.00 Units on a scale | Standard Deviation 1.41 |
| Prior Placebo | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Last visit (N= 176, 41, 23) | 3.32 Units on a scale | Standard Deviation 1.52 |
| Prior Aripiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 52 (N= 16, 2, 2) | 3.00 Units on a scale | Standard Deviation 1.41 |
| Prior Aripiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 32 (N= 18, 5, 2) | 3.00 Units on a scale | Standard Deviation 1.41 |
| Prior Aripiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 6 (N= 139, 31, 15) | 2.60 Units on a scale | Standard Deviation 1.18 |
| Prior Aripiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 4 (N= 148, 34, 18) | 2.94 Units on a scale | Standard Deviation 1.21 |
| Prior Aripiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 38 (N= 17, 3, 2) | 3.00 Units on a scale | Standard Deviation 1.41 |
| Prior Aripiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 2 (N= 164, 40, 21) | 3.38 Units on a scale | Standard Deviation 1.28 |
| Prior Aripiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Day 4 (N= 169, 36, 22) | 3.23 Units on a scale | Standard Deviation 1.15 |
| Prior Aripiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 44 (N= 17, 2, 2) | 3.00 Units on a scale | Standard Deviation 1.41 |
| Prior Aripiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 1 (N= 167, 40, 23) | 3.13 Units on a scale | Standard Deviation 1.14 |
| Prior Aripiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 20 (N= 20, 5, 2) | 4.00 Units on a scale | Standard Deviation 0 |
| Prior Aripiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 14 (N= 20, 6, 2) | 4.50 Units on a scale | Standard Deviation 0.71 |
| Prior Aripiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Last visit (N= 176, 41, 23) | 2.83 Units on a scale | Standard Deviation 1.19 |
| Prior Aripiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 26 (N= 19, 5, 2) | 4.00 Units on a scale | Standard Deviation 0 |
| Prior Aripiprazole | Mean Clinical Global Impression- Improvement Scale (CGI-I) Total Score. | Week 8 (N= 20, 6, 2) | 3.00 Units on a scale | Standard Deviation 1.41 |
Secondary
Percentage of Participants Who Discontinued Due to Lack of Efficacy.
Discontinuation rate for the participants discontinued due to lack of efficacy were examined.
Time frame: Last Visit
Population: The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prior Brexpiprazole | Percentage of Participants Who Discontinued Due to Lack of Efficacy. | 2.8 Percentage of participants. |
| Prior Placebo | Percentage of Participants Who Discontinued Due to Lack of Efficacy. | 0.0 Percentage of participants. |
| Prior Aripiprazole | Percentage of Participants Who Discontinued Due to Lack of Efficacy. | 0.0 Percentage of participants. |
Secondary
Percentage of Participants With a Positive Response Rate.
Response rate was defined as a reduction of ≥ 30% from Baseline in PANSS total score or CGI-I score of 1 (very much improved) or 2 (much improved) at the Last Visit.
Time frame: Last Visit
Population: The efficacy analysis dataset comprised those participants who received study medication of brexpiprazole and had at least one Post-Baseline assessment for PANSS total score.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prior Brexpiprazole | Percentage of Participants With a Positive Response Rate. | 33.5 Percentage of participants |
| Prior Placebo | Percentage of Participants With a Positive Response Rate. | 36.6 Percentage of participants |
| Prior Aripiprazole | Percentage of Participants With a Positive Response Rate. | 45.8 Percentage of participants |