Attention Deficit Hyperactivity Disorder (ADHD)
Conditions
Brief summary
Children between the ages of 6-12 years who are diagnosed with impulsive aggression comorbid with ADHD and have participated in the 810P301 or 810P302 study were invited to participate in this study. This was a Phase 3 open-label extension (OLE) study to collect long-term safety data on the use of SPN-810 in treating impulsive aggression in pediatric subjects with ADHD when taken in conjunction with standard ADHD treatment. After confirmation of eligibility, all subjects were treated with SPN-810. Subjects were given a choice to extend participation in this study every 6 months for up to 36 months.
Detailed description
Study 810P304 is a multicenter, open-label, extension study aimed to assess safety of SPN-810 in the treatment of IA in patients aged 6-17 years with ADHD in conjunction with standard ADHD treatment. The study has three phases: Optimization, Maintenance, and Taper. All subjects who complete the randomized, double-blind portion of study 810P301, 810P302, 810P503 or 810P204 will have the option to participate in the OLE study in which all subjects will receive active Study Medication (SM) treatment. Subjects who choose to participate in the OLE will receive blinded conversion medication kits at Visit 6 of the previous SPN-810 double-blind randomization study (810P301, 810P302) or at Visit 4 for subjects completing the 810P204 study. Subjects, who have completed the 810P503 study and, chose to participate in this study, will receive the blinded conversion card at Visit 7.
Interventions
DRUGSPN-810
Sponsors
Supernus Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Healthy male or female subjects, who completed and converted from a satisfactory participation in the study 810P301, 810P302, 810P503 and 810P204 or discontinued early from the previous study during the maintenance phase and allowed to enroll only after consultation between the Investigator, the Medical Monitor and the Sponsor. 2. Medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs). 3. Existing diagnosis of ADHD, as described by DSM-5 and confirmed by the K-SADS PL 2013 from study 810P301 or 810P302 or by the MINI-KID from study 810P503 or 810P204. 4. Currently receiving monotherapy treatment with FDA-approved ADHD medication (stimulants and non-stimulants). 5. Weight of at least 20 kg. 6. Written Informed Consent obtained from the subject's parent or legally authorized representative (LAR), and written Informed Assent obtained from the subject if appropriate.
Exclusion criteria
1. Body Mass Index (BMI) in 99th percentile or above. 2. Clinically significant change in health status, safety concern or any other reason that, in the opinion of the Sponsor or the Investigator, would prevent the subject from participating in this study or successfully completing this study. 3. Pregnancy or refusal to practice contraception during the study (for female subjects of childbearing potential and sexually active males). 4. Current substance or alcohol use. 5. Suicidal thoughts or behaviors confirmed at Visit 7 for 810P301 or 810P302, Visit 8 for 810P503 or Visit 6 for 810P204 studies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | 17-time points: Months 3 (V5), 6 (V6), 9 (V7), 12 (V8), 15 (V9), 18 (V10), 21 (V11), 24 (V12), 27 (V13), 30 (V14), 33 (V15), 36 (V16), 39 (V17), 42 (V18), 45 (V19), 48 (V20) and month 60 (Visit 24). | R-MOAS scale gauges the severity of aggressive behavior: the frequency of the 16 behaviors is rated over the past week in 4 areas (VE, PH, PR, SE). For each open question in each area, the parent-rated the aggressive behaviors on a scale from 0 to 5 or more times. To each area corresponds a weighted category: Verbal Incidents (VE)=1, Incidents Toward Other (PH) =4, Incidents Involving Property (PR)=2 and Incidents Directed Toward Self (SE)=3. Therefore, the sum of each area yields a maximum weighted score of 20 (VE), 120 (PH), 60 (PR), and 90 (SE). The total score is the sum of the four area scores or 0-290; the higher the score, the more severe the aggressive behavior is. The data represent the total score change from baseline at each visit for the duration of the study, a total of 60 months. The baseline score represents the total score at the last visit of each double-blind study. |
| Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | 20-time points: Week 2 (V2), Week 4 (V3), Week 8 (V4), Months 3 (V5), 6 (V6), 9 (V7), 12 (V8), 15 (V9),18 (V10), 21 (V11), 24 (V12), 27 (V13), 30 (V14), 33 (V15), 36 (V16), 39 (V17), 42 (V18), 45 (V19), 48 (V20) and month 60 (Visit 24). | The Clinical Global Impression - Severity of Illness (CGI-S) is a single item clinician rating of clinician's assessment of the severity of IA behaviors. CGI-S was evaluated by the Investigator at each visit on a 7- point scale with 1=Normal, 2=Borderline ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Extremely ill. Data represent the change from baseline to each visit during the study. The baseline score represents the total score at the last visit of each double-blind study. |
| Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | 20-time points: Week 2 (V2), Week 4 (V3), Week 8 (V4), Months 3 (V5), 6 (V6), 9 (V7), 12 (V8), 15 (V9),18 (V10), 21 (V11), 24 (V12), 27 (V13), 30 (V14), 33 (V15), 36 (V16), 39 (V17), 42 (V18), 45 (V19), 48 (V20) and Month 60 (Visit 24). | The Clinical Global Impression - Improvement Scale (CGI-I) is a clinician's assessment of how much the IA behaviors have improved or worsened relative to a baseline state at the beginning of treatment. CGI-I was evaluated by the Investigator at each visit on a 7-point scale with 1=Very much improved, 2= Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Data represent the score at each visit during the study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| <18 mg SPN-810 Subjects treated with 6,12 or 15 mg/day SPN-810 | 38 |
| 18 mg to <24 mg SPN-810 Subjects treated with 18 mg/day or 21 mg/day SPN-810 | 159 |
| 24 mg to <36 mg SPN-810 Subjects treated with 24, 27 or 30 mg/day SPN-810 | 131 |
| 36 mg to ≤54 mg SPN-810 Subjects treated with 36, 42, 45, 48 or 54 mg/day SPN-810 | 163 |
| Total | 491 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 10 | 10 | 11 |
| Overall Study | Lack of Efficacy | 0 | 0 | 0 | 4 |
| Overall Study | Lost to Follow-up | 8 | 33 | 19 | 22 |
| Overall Study | Missing | 0 | 5 | 1 | 5 |
| Overall Study | Physician Decision | 3 | 7 | 14 | 8 |
| Overall Study | Protocol Violation | 2 | 6 | 6 | 8 |
| Overall Study | Sponsor terminated study, SM non-compliance, Site closure, Subjects relocated or hospitalized. | 9 | 43 | 40 | 58 |
| Overall Study | Withdrawal by Parent/Guardian | 9 | 47 | 33 | 38 |
| Overall Study | Withdrawal by Subject | 4 | 7 | 6 | 8 |
Baseline characteristics
| Characteristic | <18 mg SPN-810 | 18 mg to <24 mg SPN-810 | 24 mg to <36 mg SPN-810 | 36 mg to ≤54 mg SPN-810 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 8.6 years STANDARD_DEVIATION 1.78 | 9.3 years STANDARD_DEVIATION 1.92 | 9.2 years STANDARD_DEVIATION 1.91 | 9.9 years STANDARD_DEVIATION 2.14 | 9.4 years STANDARD_DEVIATION 2.02 |
| Age, Customized 12-17 | 0 participants | 5 participants | 3 participants | 16 participants | 24 participants |
| Age, Customized 6-12 | 38 participants | 154 participants | 128 participants | 147 participants | 467 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 26 Participants | 26 Participants | 29 Participants | 87 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 131 Participants | 104 Participants | 133 Participants | 400 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 3 Participants | 0 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 57 Participants | 26 Participants | 41 Participants | 135 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 10 Participants | 4 Participants | 9 Participants | 24 Participants |
| Race (NIH/OMB) White | 26 Participants | 88 Participants | 101 Participants | 110 Participants | 325 Participants |
| Sex: Female, Male Female | 9 Participants | 34 Participants | 29 Participants | 32 Participants | 104 Participants |
| Sex: Female, Male Male | 29 Participants | 125 Participants | 102 Participants | 131 Participants | 387 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 159 | 0 / 131 | 0 / 163 |
| other Total, other adverse events | 18 / 38 | 56 / 159 | 56 / 131 | 66 / 163 |
| serious Total, serious adverse events | 3 / 38 | 5 / 159 | 5 / 131 | 9 / 163 |
Outcome results
Primary
Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I)
The Clinical Global Impression - Improvement Scale (CGI-I) is a clinician's assessment of how much the IA behaviors have improved or worsened relative to a baseline state at the beginning of treatment. CGI-I was evaluated by the Investigator at each visit on a 7-point scale with 1=Very much improved, 2= Much improved, 3= Minimally improved, 4= No change, 5= Minimally worse, 6= Much worse, 7= Very much worse. Data represent the score at each visit during the study.
Time frame: 20-time points: Week 2 (V2), Week 4 (V3), Week 8 (V4), Months 3 (V5), 6 (V6), 9 (V7), 12 (V8), 15 (V9),18 (V10), 21 (V11), 24 (V12), 27 (V13), 30 (V14), 33 (V15), 36 (V16), 39 (V17), 42 (V18), 45 (V19), 48 (V20) and Month 60 (Visit 24).
Population: Safety Population: Safety population is defined as all subjects who received at least 1 dose of study drug during the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 6 | 1.7 score on a scale | Standard Deviation 0.66 |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Week 4 | 2.1 score on a scale | Standard Deviation 1 |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 15 | 2.3 score on a scale | Standard Deviation 1.77 |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 12 | 2.5 score on a scale | Standard Deviation 1.33 |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 9 | 1.8 score on a scale | Standard Deviation 0.65 |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 39 | 1.0 score on a scale | — |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 33 | 1.0 score on a scale | Standard Deviation 0 |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 30 | 2.3 score on a scale | Standard Deviation 1.89 |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Week 8 | 1.9 score on a scale | Standard Deviation 0.8 |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Week 2 | 2.7 score on a scale | Standard Deviation 1.25 |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 27 | 2.4 score on a scale | Standard Deviation 1.52 |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 24 | 1.2 score on a scale | Standard Deviation 0.41 |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 3 | 1.9 score on a scale | Standard Deviation 0.98 |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 36 | 1.0 score on a scale | — |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 21 | 1.5 score on a scale | Standard Deviation 0.55 |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 18 | 2.6 score on a scale | Standard Deviation 2.07 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Week 8 | 1.9 score on a scale | Standard Deviation 1.05 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Week 2 | 2.1 score on a scale | Standard Deviation 0.96 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Week 4 | 1.9 score on a scale | Standard Deviation 0.94 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 3 | 1.8 score on a scale | Standard Deviation 0.84 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 6 | 1.7 score on a scale | Standard Deviation 0.78 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 9 | 1.7 score on a scale | Standard Deviation 0.69 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 12 | 1.8 score on a scale | Standard Deviation 1.1 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 15 | 1.8 score on a scale | Standard Deviation 1.11 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 18 | 1.9 score on a scale | Standard Deviation 1.11 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 21 | 1.7 score on a scale | Standard Deviation 0.67 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 24 | 1.7 score on a scale | Standard Deviation 0.6 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 27 | 1.6 score on a scale | Standard Deviation 0.49 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 30 | 1.5 score on a scale | Standard Deviation 0.51 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 33 | 1.5 score on a scale | Standard Deviation 0.64 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 36 | 1.5 score on a scale | Standard Deviation 0.52 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 39 | 1.3 score on a scale | Standard Deviation 0.49 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 42 | 1.5 score on a scale | Standard Deviation 0.71 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 45 | 1.0 score on a scale | — |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 18 | 1.9 score on a scale | Standard Deviation 0.71 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 3 | 2.4 score on a scale | Standard Deviation 1.11 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 21 | 2.0 score on a scale | Standard Deviation 0.77 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 60 | 3.0 score on a scale | — |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 24 | 2.0 score on a scale | Standard Deviation 0.72 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Week 8 | 2.4 score on a scale | Standard Deviation 0.97 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 42 | 2.0 score on a scale | Standard Deviation 0 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 27 | 1.7 score on a scale | Standard Deviation 0.69 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 30 | 1.8 score on a scale | Standard Deviation 0.75 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Week 4 | 2.6 score on a scale | Standard Deviation 1.18 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 33 | 1.8 score on a scale | Standard Deviation 0.96 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 36 | 2.3 score on a scale | Standard Deviation 0.58 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 9 | 2.0 score on a scale | Standard Deviation 0.8 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Week 2 | 2.9 score on a scale | Standard Deviation 1.19 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 12 | 1.9 score on a scale | Standard Deviation 0.8 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 6 | 2.2 score on a scale | Standard Deviation 1.13 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 15 | 2.0 score on a scale | Standard Deviation 0.76 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 39 | 2.5 score on a scale | Standard Deviation 0.71 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 48 | 1.0 score on a scale | — |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 60 | 1.0 score on a scale | — |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 3 | 2.3 score on a scale | Standard Deviation 1.06 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 18 | 1.9 score on a scale | Standard Deviation 0.64 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 33 | 1.9 score on a scale | Standard Deviation 0.66 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 39 | 1.5 score on a scale | Standard Deviation 0.52 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Week 2 | 2.9 score on a scale | Standard Deviation 0.98 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 21 | 1.9 score on a scale | Standard Deviation 0.76 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Week 8 | 2.5 score on a scale | Standard Deviation 1.05 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 45 | 1.5 score on a scale | Standard Deviation 0.71 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 12 | 2.1 score on a scale | Standard Deviation 0.92 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 24 | 1.8 score on a scale | Standard Deviation 0.98 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 36 | 1.9 score on a scale | Standard Deviation 0.73 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 15 | 2.1 score on a scale | Standard Deviation 0.8 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 9 | 2.1 score on a scale | Standard Deviation 0.91 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 27 | 1.9 score on a scale | Standard Deviation 1 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Week 4 | 2.7 score on a scale | Standard Deviation 1.02 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 42 | 1.7 score on a scale | Standard Deviation 1.11 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 6 | 2.2 score on a scale | Standard Deviation 1.02 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Improvement Scale (CGI-I) | Month 30 | 1.9 score on a scale | Standard Deviation 1.21 |
Primary
Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S)
The Clinical Global Impression - Severity of Illness (CGI-S) is a single item clinician rating of clinician's assessment of the severity of IA behaviors. CGI-S was evaluated by the Investigator at each visit on a 7- point scale with 1=Normal, 2=Borderline ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Extremely ill. Data represent the change from baseline to each visit during the study. The baseline score represents the total score at the last visit of each double-blind study.
Time frame: 20-time points: Week 2 (V2), Week 4 (V3), Week 8 (V4), Months 3 (V5), 6 (V6), 9 (V7), 12 (V8), 15 (V9),18 (V10), 21 (V11), 24 (V12), 27 (V13), 30 (V14), 33 (V15), 36 (V16), 39 (V17), 42 (V18), 45 (V19), 48 (V20) and month 60 (Visit 24).
Population: Safety Population: Safety population is defined as all subjects who received at least 1 dose of study drug during the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 6 | -2.0 score on a scale | Standard Deviation 0.95 |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Week 4 | -1.6 score on a scale | Standard Deviation 1.26 |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 15 | -1.7 score on a scale | Standard Deviation 1.25 |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 12 | -1.5 score on a scale | Standard Deviation 1.13 |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 9 | -1.9 score on a scale | Standard Deviation 0.9 |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 39 | -4.0 score on a scale | — |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 33 | -3.5 score on a scale | Standard Deviation 0.71 |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 30 | -2.0 score on a scale | Standard Deviation 1.83 |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Week 8 | -2.0 score on a scale | Standard Deviation 1.2 |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Week 2 | -1.2 score on a scale | Standard Deviation 1.33 |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 27 | -1.8 score on a scale | Standard Deviation 1.48 |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 24 | -2.5 score on a scale | Standard Deviation 1.05 |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 3 | -1.9 score on a scale | Standard Deviation 1.37 |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 36 | -4.0 score on a scale | — |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 21 | -2.3 score on a scale | Standard Deviation 1.03 |
| <18 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 18 | -1.5 score on a scale | Standard Deviation 1.51 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Week 8 | -2.1 score on a scale | Standard Deviation 1.18 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Week 2 | -1.8 score on a scale | Standard Deviation 1.13 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Week 4 | -2.1 score on a scale | Standard Deviation 1.1 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 3 | -2.2 score on a scale | Standard Deviation 1.08 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 6 | -2.2 score on a scale | Standard Deviation 1.07 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 9 | -2.2 score on a scale | Standard Deviation 1.02 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 12 | -2.3 score on a scale | Standard Deviation 0.96 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 15 | -2.3 score on a scale | Standard Deviation 0.93 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 18 | -2.1 score on a scale | Standard Deviation 1.03 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 21 | -2.2 score on a scale | Standard Deviation 1.01 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 24 | -2.3 score on a scale | Standard Deviation 0.89 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 27 | -2.2 score on a scale | Standard Deviation 0.87 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 30 | -2.4 score on a scale | Standard Deviation 0.88 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 33 | -2.3 score on a scale | Standard Deviation 1.03 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 36 | -2.6 score on a scale | Standard Deviation 0.79 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 39 | -2.7 score on a scale | Standard Deviation 0.95 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 42 | -3.0 score on a scale | Standard Deviation 0 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 45 | -4.0 score on a scale | — |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 18 | -2.0 score on a scale | Standard Deviation 1.08 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 3 | -1.5 score on a scale | Standard Deviation 1.15 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 21 | -1.9 score on a scale | Standard Deviation 1.03 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 60 | -1.0 score on a scale | — |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 24 | -2.1 score on a scale | Standard Deviation 1.13 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Week 8 | -1.4 score on a scale | Standard Deviation 1.13 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 42 | -2.0 score on a scale | Standard Deviation 0 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 27 | -1.9 score on a scale | Standard Deviation 1.03 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 30 | -2.0 score on a scale | Standard Deviation 1.13 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Week 4 | -1.2 score on a scale | Standard Deviation 1.12 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 33 | -2.8 score on a scale | Standard Deviation 1.71 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 36 | -1.7 score on a scale | Standard Deviation 0.58 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 9 | -1.8 score on a scale | Standard Deviation 0.92 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Week 2 | -1.0 score on a scale | Standard Deviation 0.94 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 12 | -2.0 score on a scale | Standard Deviation 1.01 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 6 | -1.5 score on a scale | Standard Deviation 0.95 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 15 | -1.9 score on a scale | Standard Deviation 0.9 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 39 | -1.5 score on a scale | Standard Deviation 0.71 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 48 | -3.0 score on a scale | — |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 60 | -3.0 score on a scale | — |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 3 | -1.6 score on a scale | Standard Deviation 0.98 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 18 | -2.0 score on a scale | Standard Deviation 0.9 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 33 | -1.8 score on a scale | Standard Deviation 0.89 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 39 | -2.1 score on a scale | Standard Deviation 0.7 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Week 2 | -1.0 score on a scale | Standard Deviation 0.95 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 21 | -1.9 score on a scale | Standard Deviation 0.92 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Week 8 | -1.5 score on a scale | Standard Deviation 1.02 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 45 | -2.0 score on a scale | Standard Deviation 0 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 12 | -1.8 score on a scale | Standard Deviation 1.03 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 24 | -1.9 score on a scale | Standard Deviation 0.98 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 36 | -1.9 score on a scale | Standard Deviation 0.73 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 15 | -1.8 score on a scale | Standard Deviation 0.97 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 9 | -1.8 score on a scale | Standard Deviation 0.97 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 27 | -2.0 score on a scale | Standard Deviation 0.95 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Week 4 | -1.3 score on a scale | Standard Deviation 1.06 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 42 | -2.0 score on a scale | Standard Deviation 1.15 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 6 | -1.8 score on a scale | Standard Deviation 0.95 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Impulsive Aggression (IA) Measured by Clinical Global Impression - Severity Scale (CGI-S) | Month 30 | -2.2 score on a scale | Standard Deviation 0.99 |
Primary
Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score
R-MOAS scale gauges the severity of aggressive behavior: the frequency of the 16 behaviors is rated over the past week in 4 areas (VE, PH, PR, SE). For each open question in each area, the parent-rated the aggressive behaviors on a scale from 0 to 5 or more times. To each area corresponds a weighted category: Verbal Incidents (VE)=1, Incidents Toward Other (PH) =4, Incidents Involving Property (PR)=2 and Incidents Directed Toward Self (SE)=3. Therefore, the sum of each area yields a maximum weighted score of 20 (VE), 120 (PH), 60 (PR), and 90 (SE). The total score is the sum of the four area scores or 0-290; the higher the score, the more severe the aggressive behavior is. The data represent the total score change from baseline at each visit for the duration of the study, a total of 60 months. The baseline score represents the total score at the last visit of each double-blind study.
Time frame: 17-time points: Months 3 (V5), 6 (V6), 9 (V7), 12 (V8), 15 (V9), 18 (V10), 21 (V11), 24 (V12), 27 (V13), 30 (V14), 33 (V15), 36 (V16), 39 (V17), 42 (V18), 45 (V19), 48 (V20) and month 60 (Visit 24).
Population: Safety Population: Safety population is defined as all subjects who received at least 1 dose of study drug during the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 21 | -7.0 score on a scale | Standard Deviation 4.69 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 30 | -2.3 score on a scale | Standard Deviation 2.87 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 21 | -20.0 score on a scale | Standard Deviation 8 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 36 | -6.0 score on a scale | — |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 21 | -11.7 score on a scale | Standard Deviation 10.84 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 30 | -14.5 score on a scale | Standard Deviation 9.85 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 21 | -2.5 score on a scale | Standard Deviation 3.99 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 33 | -46.5 score on a scale | Standard Deviation 33.23 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 21 | -41.2 score on a scale | Standard Deviation 12.8 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 30 | -17.0 score on a scale | Standard Deviation 17.7 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 24 | -6.0 score on a scale | Standard Deviation 5.66 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 33 | 0.0 score on a scale | Standard Deviation 0 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 24 | -16.7 score on a scale | Standard Deviation 13.25 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 30 | -10.0 score on a scale | Standard Deviation 4.24 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 24 | -13.3 score on a scale | Standard Deviation 10.25 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 24 | 1.5 score on a scale | Standard Deviation 6.5 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 27 | -35.4 score on a scale | Standard Deviation 28.79 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 24 | -34.5 score on a scale | Standard Deviation 27.24 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 33 | -14.0 score on a scale | Standard Deviation 11.31 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 27 | -6.4 score on a scale | Standard Deviation 6.8 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 27 | 1.8 score on a scale | Standard Deviation 5.85 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 27 | -19.2 score on a scale | Standard Deviation 15.07 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 27 | -11.6 score on a scale | Standard Deviation 7.92 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 33 | -24.0 score on a scale | Standard Deviation 16.97 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 39 | 0.0 score on a scale | — |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 39 | 4.0 score on a scale | — |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 15 | -4.5 score on a scale | Standard Deviation 5.87 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 33 | -8.5 score on a scale | Standard Deviation 4.95 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 6 | -7.0 score on a scale | Standard Deviation 4.62 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 3 | -7.1 score on a scale | Standard Deviation 5.18 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 3 | -23.7 score on a scale | Standard Deviation 17.41 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 15 | -13.4 score on a scale | Standard Deviation 10.59 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 3 | -16.1 score on a scale | Standard Deviation 11.47 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 3 | -7.3 score on a scale | Standard Deviation 10.15 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 15 | -14.4 score on a scale | Standard Deviation 15.11 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 3 | -54.1 score on a scale | Standard Deviation 32.78 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 36 | -18.0 score on a scale | — |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 15 | -5.5 score on a scale | Standard Deviation 3.87 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 6 | -23.6 score on a scale | Standard Deviation 12.84 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 6 | -14.4 score on a scale | Standard Deviation 10.54 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 39 | -12.0 score on a scale | — |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 12 | -27.6 score on a scale | Standard Deviation 28.46 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 6 | -7.2 score on a scale | Standard Deviation 7.75 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 6 | -52.2 score on a scale | Standard Deviation 26.54 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 12 | -2.8 score on a scale | Standard Deviation 6.87 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 9 | -6.4 score on a scale | Standard Deviation 4.3 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 39 | -12.0 score on a scale | — |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 9 | -17.7 score on a scale | Standard Deviation 15.79 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 36 | 0.0 score on a scale | — |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 12 | -9.5 score on a scale | Standard Deviation 12.63 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 9 | -13.9 score on a scale | Standard Deviation 9.27 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 39 | -4.0 score on a scale | — |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 9 | -8.1 score on a scale | Standard Deviation 8.72 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 9 | -46.1 score on a scale | Standard Deviation 25.55 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 12 | -11.1 score on a scale | Standard Deviation 14.71 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 15 | -37.8 score on a scale | Standard Deviation 26.08 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 36 | -8.0 score on a scale | — |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 18 | -5.8 score on a scale | Standard Deviation 7.03 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 12 | -4.2 score on a scale | Standard Deviation 5.57 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 18 | -15.5 score on a scale | Standard Deviation 15.03 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 18 | -17.3 score on a scale | Standard Deviation 10.36 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 18 | -1.5 score on a scale | Standard Deviation 4.24 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 36 | -4.0 score on a scale | — |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 30 | -43.8 score on a scale | Standard Deviation 30.91 |
| <18 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 18 | -40.0 score on a scale | Standard Deviation 30.85 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 21 | -6.9 score on a scale | Standard Deviation 6.84 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 3 | -13.6 score on a scale | Standard Deviation 13.48 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 36 | -47.5 score on a scale | Standard Deviation 12.53 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 15 | -20.7 score on a scale | Standard Deviation 19.65 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 9 | -7.1 score on a scale | Standard Deviation 10.94 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 3 | -6.3 score on a scale | Standard Deviation 10.19 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 42 | -18.0 score on a scale | — |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 36 | -17.2 score on a scale | Standard Deviation 6.41 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 12 | -19.1 score on a scale | Standard Deviation 19.43 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 3 | -45.2 score on a scale | Standard Deviation 40.5 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 39 | -15.4 score on a scale | Standard Deviation 5.97 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 36 | -7.3 score on a scale | Standard Deviation 3.65 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 15 | -7.2 score on a scale | Standard Deviation 6.26 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 18 | -17.5 score on a scale | Standard Deviation 13.01 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 21 | -22.7 score on a scale | Standard Deviation 21.11 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 9 | -52.2 score on a scale | Standard Deviation 39.56 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 30 | -17.7 score on a scale | Standard Deviation 10.32 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 45 | -8.0 score on a scale | — |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 21 | -18.7 score on a scale | Standard Deviation 13.19 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 33 | -39.4 score on a scale | Standard Deviation 34.32 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 6 | -19.2 score on a scale | Standard Deviation 24.44 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 42 | -3.0 score on a scale | — |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 21 | -10.0 score on a scale | Standard Deviation 13.05 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 12 | -47.0 score on a scale | Standard Deviation 40.33 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 30 | -19.6 score on a scale | Standard Deviation 20.55 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 45 | -18.0 score on a scale | — |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 21 | -58.3 score on a scale | Standard Deviation 45.11 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 33 | -5.4 score on a scale | Standard Deviation 8.58 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 6 | -12.5 score on a scale | Standard Deviation 13.35 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 30 | -54.5 score on a scale | Standard Deviation 39.26 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 24 | -7.5 score on a scale | Standard Deviation 5.18 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 15 | -50.7 score on a scale | Standard Deviation 43.31 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 30 | -8.3 score on a scale | Standard Deviation 5.79 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 18 | -56.0 score on a scale | Standard Deviation 42.08 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 24 | -24.3 score on a scale | Standard Deviation 19.04 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 39 | -41.6 score on a scale | Standard Deviation 13.18 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 6 | -6.8 score on a scale | Standard Deviation 10.29 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 36 | -8.8 score on a scale | Standard Deviation 9.78 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 24 | -19.2 score on a scale | Standard Deviation 9.87 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 33 | -15.7 score on a scale | Standard Deviation 12.46 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 27 | -59.6 score on a scale | Standard Deviation 37.18 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 12 | -7.0 score on a scale | Standard Deviation 11.8 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 24 | -8.9 score on a scale | Standard Deviation 12.01 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 39 | -13.1 score on a scale | Standard Deviation 7.9 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 12 | -6.6 score on a scale | Standard Deviation 5.91 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 6 | -44.0 score on a scale | Standard Deviation 41.31 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 24 | -59.9 score on a scale | Standard Deviation 34.3 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 42 | -40.0 score on a scale | — |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 27 | -10.3 score on a scale | Standard Deviation 13.75 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 18 | -7.8 score on a scale | Standard Deviation 12.94 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 27 | -7.6 score on a scale | Standard Deviation 5.69 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 39 | -5.3 score on a scale | Standard Deviation 4.39 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 18 | -6.7 score on a scale | Standard Deviation 6.49 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 9 | -6.8 score on a scale | Standard Deviation 5.03 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 27 | -23.5 score on a scale | Standard Deviation 19.26 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 33 | -11.5 score on a scale | Standard Deviation 23.07 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 27 | -18.2 score on a scale | Standard Deviation 10.48 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 45 | -14.0 score on a scale | — |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 42 | -7.0 score on a scale | — |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 12 | -14.4 score on a scale | Standard Deviation 13.11 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 45 | -47.0 score on a scale | — |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 15 | -6.3 score on a scale | Standard Deviation 12.96 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 9 | -22.6 score on a scale | Standard Deviation 21.97 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 30 | -8.9 score on a scale | Standard Deviation 13.7 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 18 | -24.0 score on a scale | Standard Deviation 20.5 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 36 | -14.3 score on a scale | Standard Deviation 9.26 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 6 | -5.4 score on a scale | Standard Deviation 6.05 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 9 | -15.6 score on a scale | Standard Deviation 11.85 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 3 | -6.8 score on a scale | Standard Deviation 5.57 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 42 | -12.0 score on a scale | — |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 15 | -16.5 score on a scale | Standard Deviation 12.78 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 45 | -7.0 score on a scale | — |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 3 | -18.5 score on a scale | Standard Deviation 21.57 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 39 | -7.7 score on a scale | Standard Deviation 5.71 |
| 18 mg to < 24 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 33 | -6.8 score on a scale | Standard Deviation 3.12 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 12 | -18.2 score on a scale | Standard Deviation 16.54 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 39 | -7.0 score on a scale | Standard Deviation 15.56 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 39 | 4.5 score on a scale | Standard Deviation 6.36 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 39 | -9.0 score on a scale | Standard Deviation 31.11 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 42 | -9.0 score on a scale | Standard Deviation 7.07 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 42 | -14.0 score on a scale | Standard Deviation 19.8 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 42 | -7.0 score on a scale | Standard Deviation 7.07 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 42 | -3.0 score on a scale | Standard Deviation 4.24 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 42 | -33.0 score on a scale | Standard Deviation 15.56 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 60 | -10.0 score on a scale | — |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 60 | 12.0 score on a scale | — |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 60 | -12.0 score on a scale | — |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 60 | 3.0 score on a scale | — |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 60 | -7.0 score on a scale | — |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 30 | -55.3 score on a scale | Standard Deviation 29.39 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 3 | -5.5 score on a scale | Standard Deviation 5.41 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 3 | -13.5 score on a scale | Standard Deviation 17.28 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 3 | -9.9 score on a scale | Standard Deviation 10.26 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 3 | -6.4 score on a scale | Standard Deviation 9.42 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 3 | -35.2 score on a scale | Standard Deviation 30.97 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 6 | -6.2 score on a scale | Standard Deviation 4.93 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 6 | -16.1 score on a scale | Standard Deviation 15.55 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 6 | -11.6 score on a scale | Standard Deviation 11.27 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 6 | -7.5 score on a scale | Standard Deviation 8.4 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 6 | -41.4 score on a scale | Standard Deviation 28.5 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 9 | -6.5 score on a scale | Standard Deviation 6.33 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 9 | -15.7 score on a scale | Standard Deviation 16.05 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 9 | -11.7 score on a scale | Standard Deviation 12 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 9 | -9.2 score on a scale | Standard Deviation 8.92 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 9 | -43.2 score on a scale | Standard Deviation 30.59 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 15 | -47.6 score on a scale | Standard Deviation 26.68 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 18 | -7.0 score on a scale | Standard Deviation 4.77 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 18 | -16.9 score on a scale | Standard Deviation 15.12 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 18 | -13.9 score on a scale | Standard Deviation 10.45 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 18 | -9.8 score on a scale | Standard Deviation 8.74 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 18 | -47.6 score on a scale | Standard Deviation 25.64 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 21 | -7.9 score on a scale | Standard Deviation 5.71 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 21 | -18.3 score on a scale | Standard Deviation 14.44 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 21 | -15.2 score on a scale | Standard Deviation 11.67 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 21 | -9.9 score on a scale | Standard Deviation 9.95 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 21 | -51.4 score on a scale | Standard Deviation 27.49 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 24 | -8.3 score on a scale | Standard Deviation 5.5 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 24 | -19.6 score on a scale | Standard Deviation 15.95 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 24 | -14.2 score on a scale | Standard Deviation 11.82 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 24 | -8.9 score on a scale | Standard Deviation 8.1 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 24 | -51.0 score on a scale | Standard Deviation 27.96 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 27 | -8.8 score on a scale | Standard Deviation 5.51 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 27 | -17.4 score on a scale | Standard Deviation 18.65 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 27 | -16.5 score on a scale | Standard Deviation 11.91 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 27 | -9.0 score on a scale | Standard Deviation 7.65 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 27 | -51.6 score on a scale | Standard Deviation 32.26 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 30 | -8.8 score on a scale | Standard Deviation 5.34 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 30 | -23.0 score on a scale | Standard Deviation 16.81 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 30 | -16.7 score on a scale | Standard Deviation 14.51 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 30 | -6.8 score on a scale | Standard Deviation 9.15 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 12 | -6.8 score on a scale | Standard Deviation 4.81 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 12 | -11.6 score on a scale | Standard Deviation 10.5 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 12 | -8.5 score on a scale | Standard Deviation 8.85 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 12 | -45.2 score on a scale | Standard Deviation 28.69 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 15 | -7.2 score on a scale | Standard Deviation 4.91 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 15 | -17.3 score on a scale | Standard Deviation 14.86 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 15 | -13.2 score on a scale | Standard Deviation 11.45 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 15 | -9.9 score on a scale | Standard Deviation 8.84 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 33 | -11.0 score on a scale | Standard Deviation 4.32 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 33 | -42.0 score on a scale | Standard Deviation 13.66 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 33 | -18.0 score on a scale | Standard Deviation 17.05 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 33 | -8.3 score on a scale | Standard Deviation 7.5 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 33 | -79.3 score on a scale | Standard Deviation 37.29 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 36 | -7.7 score on a scale | Standard Deviation 5.03 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 36 | -30.7 score on a scale | Standard Deviation 6.11 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 36 | -12.0 score on a scale | Standard Deviation 6 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 36 | -4.0 score on a scale | Standard Deviation 6.24 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 36 | -54.3 score on a scale | Standard Deviation 15.04 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 39 | -0.5 score on a scale | Standard Deviation 10.61 |
| 24 mg to < 36 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 39 | -6.0 score on a scale | Standard Deviation 42.43 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 18 | -6.1 score on a scale | Standard Deviation 9.38 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 18 | -15.0 score on a scale | Standard Deviation 10.45 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 18 | -19.9 score on a scale | Standard Deviation 19.78 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 9 | -36.5 score on a scale | Standard Deviation 33.44 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 18 | -6.9 score on a scale | Standard Deviation 5.79 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 15 | -42.9 score on a scale | Standard Deviation 33.47 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 45 | -24.0 score on a scale | Standard Deviation 16 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 12 | -5.9 score on a scale | Standard Deviation 6.35 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 15 | -6.7 score on a scale | Standard Deviation 8.15 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 9 | -6.6 score on a scale | Standard Deviation 8.88 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 9 | -11.2 score on a scale | Standard Deviation 12.98 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 12 | -16.1 score on a scale | Standard Deviation 18.18 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 9 | -13.7 score on a scale | Standard Deviation 16.3 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 9 | -5.0 score on a scale | Standard Deviation 5.97 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 45 | -8.3 score on a scale | Standard Deviation 2.08 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 12 | -11.8 score on a scale | Standard Deviation 13.08 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 6 | -39.2 score on a scale | Standard Deviation 34.04 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 6 | -5.6 score on a scale | Standard Deviation 8.78 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 39 | -7.5 score on a scale | Standard Deviation 3.5 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 12 | -6.7 score on a scale | Standard Deviation 8.4 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 6 | -11.8 score on a scale | Standard Deviation 13.21 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 6 | -15.9 score on a scale | Standard Deviation 17.62 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 36 | -17.1 score on a scale | Standard Deviation 9.3 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 12 | -40.4 score on a scale | Standard Deviation 34.34 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 6 | -5.9 score on a scale | Standard Deviation 5.67 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 3 | -41.3 score on a scale | Standard Deviation 34.02 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 42 | -57.0 score on a scale | Standard Deviation 32.17 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 15 | -6.2 score on a scale | Standard Deviation 6.05 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 3 | -5.3 score on a scale | Standard Deviation 8.8 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 3 | -12.6 score on a scale | Standard Deviation 11.9 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 42 | -5.6 score on a scale | Standard Deviation 8.2 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 15 | -16.5 score on a scale | Standard Deviation 18.43 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 3 | -16.9 score on a scale | Standard Deviation 17.78 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 3 | -6.4 score on a scale | Standard Deviation 5.84 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 39 | -3.9 score on a scale | Standard Deviation 9.06 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 15 | -13.5 score on a scale | Standard Deviation 12.34 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 30 | -47.7 score on a scale | Standard Deviation 31.41 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 60 | -42.0 score on a scale | — |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 36 | -5.5 score on a scale | Standard Deviation 6.91 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 42 | -15.1 score on a scale | Standard Deviation 13.85 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 33 | -5.7 score on a scale | Standard Deviation 5.99 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 60 | -6.0 score on a scale | — |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 60 | -12.0 score on a scale | — |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 42 | -27.4 score on a scale | Standard Deviation 13.55 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 33 | -15.7 score on a scale | Standard Deviation 14.33 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 60 | -12.0 score on a scale | — |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 60 | -12.0 score on a scale | — |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 39 | -16.6 score on a scale | Standard Deviation 10.02 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 33 | -12.0 score on a scale | Standard Deviation 8.41 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 48 | -55.0 score on a scale | — |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 48 | -12.0 score on a scale | — |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 36 | -57.0 score on a scale | Standard Deviation 29.94 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 33 | -3.0 score on a scale | Standard Deviation 11.16 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 48 | -6.0 score on a scale | — |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 48 | -28.0 score on a scale | — |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 42 | -8.9 score on a scale | Standard Deviation 5.37 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 33 | -36.4 score on a scale | Standard Deviation 33.14 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 48 | -9.0 score on a scale | — |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 27 | -24.7 score on a scale | Standard Deviation 19.17 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 45 | -49.0 score on a scale | Standard Deviation 22.07 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 27 | -14.5 score on a scale | Standard Deviation 11.25 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 27 | -6.7 score on a scale | Standard Deviation 3.79 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 24 | -42.6 score on a scale | Standard Deviation 33.62 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 39 | -51.6 score on a scale | Standard Deviation 27.62 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 27 | -5.9 score on a scale | Standard Deviation 7.86 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 24 | -6.0 score on a scale | Standard Deviation 8.68 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 24 | -13.3 score on a scale | Standard Deviation 9.24 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 36 | -7.9 score on a scale | Standard Deviation 7.06 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 27 | -51.8 score on a scale | Standard Deviation 29.04 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 24 | -17.7 score on a scale | Standard Deviation 18.19 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 24 | -5.5 score on a scale | Standard Deviation 5.55 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 45 | -2.0 score on a scale | Standard Deviation 9.17 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 30 | -6.8 score on a scale | Standard Deviation 4.97 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 21 | -47.1 score on a scale | Standard Deviation 34.49 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 21 | -7.2 score on a scale | Standard Deviation 8.03 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 45 | -14.7 score on a scale | Standard Deviation 7.57 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 30 | -22.2 score on a scale | Standard Deviation 16.34 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 21 | -13.4 score on a scale | Standard Deviation 12.71 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 21 | -19.9 score on a scale | Standard Deviation 18.08 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 39 | -22.5 score on a scale | Standard Deviation 14.78 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PR Score Month 30 | -13.5 score on a scale | Standard Deviation 13.45 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | VE Score Month 21 | -6.7 score on a scale | Standard Deviation 5.66 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | Total Score Month 18 | -47.8 score on a scale | Standard Deviation 36.62 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | PH Score Month 36 | -26.5 score on a scale | Standard Deviation 16.13 |
| 36 mg to ≤54 mg SPN-810 | Effect of SPN810 on Retrospective-Modified Overt Aggression Scale (R-MOAS) Total Score | SE Score Month 30 | -4.9 score on a scale | Standard Deviation 9.6 |