Trial Outcomes & Findings for Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Early-Episode Schizophrenia (NCT NCT02013622)

NCT ID: NCT02013622

Last Updated: 2016-03-29

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 49 participants
• Primary outcome timeframe: Baseline and Week 16
• Results posted on: 2016-03-29

Participant Flow

This was an exploratory phase 3b, multicenter, open-label, monotherapy, flexible-dose brexpiprazole trial designed to assess the efficacy and safety of brexpiprazole in participants with early-episode schizophrenia.

The trial consisted of a 2 to 21-day screening phase, a 16-week (112-day) treatment phase, and a 30-day (+2) follow-up phase. The treatment phase was split into a medication conversion period (2, 3, or 4 weeks) and a brexpiprazole monotherapy period (14, 13, or 12 weeks) respectively.

Participant milestones

Measure	Brexpiprazole Participants received oral brexpiprazole tablets of 1 milligram per day (mg/day) to 4 mg/day, once daily (QD) for 16 Weeks.
Overall Study STARTED	49
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Measure	Brexpiprazole Participants received oral brexpiprazole tablets of 1 milligram per day (mg/day) to 4 mg/day, once daily (QD) for 16 Weeks.
Overall Study Lost to Follow-up	10
Overall Study Adverse Event	3
Overall Study Met Withdrawal Criteria	3
Overall Study Withdrawal by Subject	6
Overall Study Protocol Deviation	1
Overall Study Lack of Efficacy	1

Baseline Characteristics

Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Early-Episode Schizophrenia

Baseline characteristics by cohort

Measure	Brexpiprazole n=49 Participants Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Age, Continuous	26.1 Years STANDARD_DEVIATION 5.0 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 16

Population: All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The observed case (OC) data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.

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).

Outcome measures

Measure	Brexpiprazole n=49 Participants Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Mean Change From Baseline to Week 16 in Positive and Negative Syndrome Scale (PANSS) Total Score	-10.2 Units on a scale Standard Error 2.1

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.

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).

Outcome measures

Measure	Brexpiprazole n=49 Participants Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Mean Change From Baseline to Week 16 Scores of the Following Negative Scale Items: Active Social Avoidance, Emotional Withdrawal, Passive/Apathetic Social Withdrawal, and Difficulty in Abstract Thinking	-2.0 Units on a scale Standard Error 0.4

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.

The severity of illness for each participant was rated using the CGI-S. To perform this assessment, 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 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.

Outcome measures

Measure	Brexpiprazole n=49 Participants Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Mean Change From Baseline to Week 16 in Clinical Global Impression-Severity (CGI-S) Score	-0.6 Units on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Week 1 to Week 16

Population: All participants who took one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment, the last observation carried forward (LOCF) dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.

The improvement of each participants condition was rated for each participant using the CGI-I. The study physician rated the participants total improvement whether or not it was due entirely to drug treatment. To perform this assessment, the study physician answered the following question: "Compared to his/her condition at baseline, how much has the participant changed?" 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. The response at a given week was compared with the participants condition at Baseline prior to the first dose of study medication.

Outcome measures

Measure	Brexpiprazole n=48 Participants Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Mean Clinical Global Impression-Improvement (CGI-I) Score Week 1	3.6 Units on a scale Standard Deviation 0.7
Mean Clinical Global Impression-Improvement (CGI-I) Score Week 2	3.1 Units on a scale Standard Deviation 1.0
Mean Clinical Global Impression-Improvement (CGI-I) Score Week 3	2.7 Units on a scale Standard Deviation 1.1
Mean Clinical Global Impression-Improvement (CGI-I) Score Week 4	2.8 Units on a scale Standard Deviation 1.1
Mean Clinical Global Impression-Improvement (CGI-I) Score Week 6	2.7 Units on a scale Standard Deviation 1.2
Mean Clinical Global Impression-Improvement (CGI-I) Score Week 8	2.9 Units on a scale Standard Deviation 1.2
Mean Clinical Global Impression-Improvement (CGI-I) Score Week 10	2.8 Units on a scale Standard Deviation 1.3
Mean Clinical Global Impression-Improvement (CGI-I) Score Week 12	2.8 Units on a scale Standard Deviation 1.3
Mean Clinical Global Impression-Improvement (CGI-I) Score Week 14	2.9 Units on a scale Standard Deviation 1.3
Mean Clinical Global Impression-Improvement (CGI-I) Score Week 16	2.8 Units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, and 16

Population: All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.

The CGI-I response rate was defined as percentage of participants with CGI-I score of 1 (very much improved) or 2 (much improved).

Outcome measures

Measure	Brexpiprazole n=48 Participants Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
CGI-I Response Rate Week 4	39.6 percentage of participants
CGI-I Response Rate Week 8	35.4 percentage of participants
CGI-I Response Rate Week 12	41.7 percentage of participants
CGI-I Response Rate Week 16	41.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.

The PSP was used to measure personal and social functioning in 4 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 study physician's judgment to determine 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.

Outcome measures

Measure	Brexpiprazole n=49 Participants Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Mean Change From Baseline to Week 16 in Personal and Social Performance (PSP) Total Score	6.6 Units on a scale Standard Error 1.7

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.

The SLOF questionnaire used in this trial consists of 30 items grouped into 4 areas: social functioning, social acceptability, activities, and work skill. The SLOF scale correlates with a participant's quality of life. Total SLOF scale is sum of these 4 areas score. Each of the questions in the above domains is rated on a 5-point Likert scale. Scores on the instrument range from 30 to 150 with higher scores indicating the better the overall functioning of the patient.

Outcome measures

Measure	Brexpiprazole n=49 Participants Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Mean Change From Baseline to Week 16 in Specific Levels of Functioning (SLOF) Total Score	13.1 Units on a scale Standard Error 3.1

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.

The PSQI was a self-rated questionnaire that assessed sleep quality and disturbances over a 1-month time interval. Seven domains were measured: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. The PSQI contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if 1 is available). Only self-rated questions are included in the scoring.The 19 self-rated items are combined to form 7 "component" scores, each of which has a range of 0 - 3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The 7 component scores are then added to yield 1 "global" score, with a range of 0 - 21 points, "0" indicating no difficulty and "21" indicating severe difficulties in all areas.

Outcome measures

Measure	Brexpiprazole n=49 Participants Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Mean Change From Baseline to Week 16 in Pittsburgh Sleep Quality Index (PSQI) Total Score	-1.8 Units on a scale Standard Error 0.7

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and at least one valid Post-Baseline efficacy assessment. The OC data set consisted of actual observations recorded at each visit during treatment phase and no missing data was imputed. MMRM was performed on the OC dataset.

The TSQM-14 was a participant-rated scale used to assess subjective satisfaction with medication. The TSQM-14 provided scores on 4 domains: effectiveness (questions 1 to 3) side effects (4 to 8), convenience (9 to 11), and global satisfaction (12 to 14). The effectiveness domain was rated on a 7-point scale from "extremely satisfied" to "extremely dissatisfied." The side effects domain provided an option to skip questions 5 to 8 if the subject provided a negative response to item number 4, ie, "As a result of taking this medication, do you currently experience any side effects at all?" Scores for each domain were transformed into a final score ranging from 0 to 100, with higher numbers indicating a higher level of satisfaction.

Outcome measures

Measure	Brexpiprazole n=47 Participants Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Mean Change From Baseline to Week 16 in Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score Effectiveness	20.00 Units on a scale Standard Error 4.09
Mean Change From Baseline to Week 16 in Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score Side effects	10.25 Units on a scale Standard Error 2.98
Mean Change From Baseline to Week 16 in Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score Convenience	11.83 Units on a scale Standard Error 2.92
Mean Change From Baseline to Week 16 in Treatment Satisfaction Questionnaire for Medication (TSQM) Total Score Global satisfaction	20.67 Units on a scale Standard Error 4.33

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.

Executive function and working memory were assessed using computer based neuropsychological instruments at Baseline and Week 16/Early Termination (ET). These instruments focused on measuring impulse inhibition. Proportions of inhibitory failures (p-inhibitory failures) is measured as the proportion of no-go targets in the go-cue condition in which a participant failed to inhibit a response.

Outcome measures

Measure	Brexpiprazole n=23 Participants Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Mean Change From Baseline to Week 16 in Go/No-Go Task (P-inhibition Failures) p-inhibition failures (go cues)	0.045 failures Standard Deviation 0.326
Mean Change From Baseline to Week 16 in Go/No-Go Task (P-inhibition Failures) p-inhibition failures (no-go cues)	0.066 failures Standard Deviation 0.352

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.

Executive function and working memory were assessed using computer based neuropsychological instruments at Baseline and Week 16/Early Termination (ET). These instruments focused on measuring impulse inhibition.

Outcome measures

Measure	Brexpiprazole n=22 Participants Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Mean Change From Baseline to Week 16 in Go/No-Go Task (Mean Reaction Time) Mean reaction time (go cues)	-2.05 milliseconds Standard Deviation 68.51
Mean Change From Baseline to Week 16 in Go/No-Go Task (Mean Reaction Time) Mean reaction time (no-go cues)	-18.77 milliseconds Standard Deviation 90.18

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.

Delay discounting was a participant-completed task is an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The propensity of participants to delay reward was assessed with an MCQ. Discounting rate is estimated using, k= (A/V)1/D, where k is the discounting rate parameter, V is the immediate reward, A is the higher delayed reward and D is the amount of days to the delayed reward. The MCQ consists of 27 choices between immediate and delayed rewards. The participant chooses repeatedly between 2 hypothetical sums of money: a smaller amount now or a larger amount in the future (for example, "would you prefer $27 today or $50 in 21 days?") The answers provide an estimate of the participant's discounting rate; higher discounting rates indicate greater impulsivity. A total score is not computed for all 27 questions.

Outcome measures

Measure	Brexpiprazole n=29 Participants Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Mean Change From Baseline to Week 16 in Delay Discounting Task - Monetary Choice Questionnaire (MCQ) Scores	0.008520 unitless Standard Deviation 0.056857

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.

Delay discounting measures the extent to which the value of a reward decreased as the delay to obtaining that reward increased. The propensity of participants to delay reward was assessed with an MCQ with completion of an Experiential Discounting task (EDT). The participant chose between different amounts of money available at different delays or with different chances (probability to get the money). At the end of the session, one of the choices was selected at random, and the participant received whatever they chose in response of that question (immediate, delayed, or probabilistic amount). Formula for h-value:value = A / (1 + hO) p is probability of reward and O is odds against.The value of h indicates how the value of a reward and the probability of its occurrence decreases. The data are computerized and reflect delay discounting and impulsivity (higher discounting and higher Probability discounting shows greater impulsivity). A total score is not computed for this task.

Outcome measures

Measure	Brexpiprazole n=19 Participants Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Mean Change From Baseline to Week 16 in Delay and Probability Discounting Task (DPDT) - Experiential Discounting Task Scores Probability Discounting Task h value	2.866008 unitless Standard Deviation 168.230663
Mean Change From Baseline to Week 16 in Delay and Probability Discounting Task (DPDT) - Experiential Discounting Task Scores Delay Discounting Task k value	-103.167142 unitless Standard Deviation 414.497480

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.

Delay discounting was a participant-completed task considered as an index of impulsive behavior. It measured the extent to which the value of a reward decreased as the delay to obtaining that reward increased. During a training session, a single button with letter A or B appeared on the screen. The participant had to wait until the letter began to flash, and press the button only once. An amount of money was added to a counter and another single button appeared. During the test session, both buttons with letters A and B appeared on the screen. The participant had to choose one of the letters that remained; the other disappeared. The participant had to wait until the letter began to flash and then press the button again. An amount of money was added to the counter, and both letters appeared again. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). A total score was not calculated for this task.

Outcome measures

Measure	Brexpiprazole n=17 Participants Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Change From Baseline to Week 16 in the Mean Number of Impulsive Choices in the Delayed Reward Task (DRT)	8.9 Number of Impulsive Choices Standard Deviation 26.4

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.

Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chooses between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for food is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the "X-axis" is "days", "Y-axis" is "Food value", the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 -x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting).

Outcome measures

Measure	Brexpiprazole n=18 Participants Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Mean Change From Baseline to Week 16 in Food Delay Discounting Task	0.037 unitless Standard Deviation 0.356

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.

Delay discounting was a participant-completed task considered as an index of impulsive behavior. The participant chose between a reward they could have today and another that they could get after a specified amount of time. The participant would not receive the rewards, but was asked to make decisions as though he or she were really going to receive them. AUC is defined as area under the concentration-time curve; AUC for money is presented below. The data are computerized and reflect delay discounting and impulsivity (higher discounting shows greater impulsivity). To calculate the AUC, the "X-axis" is "days", "Y-axis" is "Money value", the actual area underneath the curve was calculated by summing the results for each delay and present value pair: x2 -x1[(y1 + y2)/2], where x1 and x2 are successive delays and y1 and y2 are the present values associated with those delays. The AUC can range from 1 (no discounting) to 0 (maximum discounting).

Outcome measures

Measure	Brexpiprazole n=18 Participants Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Mean Change From Baseline to Week 16 in Money Delay Discounting Task	0.001 unitless Standard Deviation 0.285

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: All participants who took at least one dose of brexpiprazole and who had a valid Baseline assessment and Post-Baseline efficacy assessment. The LOCF dataset recorded at scheduled treatment phase visit or, if no observation was recorded at that visit, data carried forward from the previous scheduled treatment phase visit.

The BIS-11 was a participant-rated scale designed to assess impulsive personality traits. The BIS-11 consisted of 30 items scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). The scores provided information to assess 6 first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and 3 second-order factors (motor impulsiveness, non-planning impulsiveness, and attentional impulsiveness). The total score ranged from 30 to 120, with higher scores indicating impulsive personality traits. It took 10 to 15 minutes to complete the BIS-11. The BIS-11 was administered at the following visits: Baseline and Week 16/ET.

Outcome measures

Measure	Brexpiprazole n=29 Participants Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Mean Change From Baseline to Week 16 in Barratt Impulsiveness Scale (BIS) 11-Item	-4.8 Units on a scale Standard Deviation 11.3

Adverse Events

Brexpiprazole

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Brexpiprazole n=49 participants at risk Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
Gastrointestinal disorders Nausea	6.1% 3/49 • Adverse events were reported from the signing of the informed consent until the 30-day (+2) follow-up visit.
Investigations Weight increased	6.1% 3/49 • Adverse events were reported from the signing of the informed consent until the 30-day (+2) follow-up visit.
Nervous system disorders Sedation	6.1% 3/49 • Adverse events were reported from the signing of the informed consent until the 30-day (+2) follow-up visit.
Nervous system disorders Somnolence	8.2% 4/49 • Adverse events were reported from the signing of the informed consent until the 30-day (+2) follow-up visit.
Psychiatric disorders Insomnia	14.3% 7/49 • Adverse events were reported from the signing of the informed consent until the 30-day (+2) follow-up visit.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place