Trial Outcomes & Findings for An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia (NCT NCT02970929)
NCT ID: NCT02970929
Last Updated: 2024-07-05
Results Overview
Number of Participants with overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation
COMPLETED
PHASE2
157 participants
From first dose of study drug to last study visit (27 weeks)
2024-07-05
Participant Flow
Subjects received open-label SEP-363856 50 mg/day from Day 1 through Day 3, and then received flexible dosing of SEP-363856 (25, 50, or 75 mg/day) for the rest of the trial.
Participant milestones
| Measure |
SEP-363856
SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily
|
|---|---|
|
Overall Study
STARTED
|
157
|
|
Overall Study
Subjects Who Received Study Medication
|
156
|
|
Overall Study
COMPLETED
|
105
|
|
Overall Study
NOT COMPLETED
|
52
|
Reasons for withdrawal
| Measure |
SEP-363856
SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily
|
|---|---|
|
Overall Study
Adverse Event
|
18
|
|
Overall Study
Lack of Efficacy
|
8
|
|
Overall Study
NON-COMPLIANCE WITH STUDY DRUG
|
1
|
|
Overall Study
INVESTIGATOR CONSIDERS SUBJECT CLINICALLY UNSTABLE, NOT APPROPRIATE FOR DISCHARGE TO AN OUTPATIENT
|
1
|
|
Overall Study
SPONSOR REQUEST THAT SUBJECT BE WITHDRAWN DUE TO POSITIVE DRUG RESULTS AND FOR THE SUBJECT'S SAFETY
|
1
|
|
Overall Study
LOST TO FOLLOWUP
|
6
|
|
Overall Study
MOVED OUT OF STATE
|
1
|
|
Overall Study
Withdrawal by Subject
|
16
|
Baseline Characteristics
An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia
Baseline characteristics by cohort
| Measure |
SEP-363856
n=156 Participants
SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily
|
|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
154 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
30.2 Years
STANDARD_DEVIATION 6.03 • n=93 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
151 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
136 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Age, Customized
>=18 - <25 years
|
38 Participants
n=93 Participants
|
|
Age, Customized
>=25 - <=40 years
|
118 Participants
n=93 Participants
|
|
Country
Hungary
|
8 Participants
n=93 Participants
|
|
Country
Romania
|
6 Participants
n=93 Participants
|
|
Country
Russia
|
68 Participants
n=93 Participants
|
|
Country
Ukraine
|
54 Participants
n=93 Participants
|
|
Country
United States
|
20 Participants
n=93 Participants
|
|
Double-blind Baseline BMI (Body Mass Index) Group
<18.5 kg/m^2
|
2 Participants
n=93 Participants
|
|
Double-blind Baseline BMI (Body Mass Index) Group
>=18.5 - <25.0 kg/m^2
|
80 Participants
n=93 Participants
|
|
Double-blind Baseline BMI (Body Mass Index) Group
>=25.0 - <30.0 kg/m^2
|
55 Participants
n=93 Participants
|
|
Double-blind Baseline BMI (Body Mass Index) Group
>=30.0 kg/m^2
|
19 Participants
n=93 Participants
|
|
Open-label Baseline BMI (Body Mass Index) Group
<18.5 kg/m^2
|
3 Participants
n=93 Participants
|
|
Open-label Baseline BMI (Body Mass Index) Group
>=18.5 - <25.0 kg/m^2
|
82 Participants
n=93 Participants
|
|
Open-label Baseline BMI (Body Mass Index) Group
>=25.0 - <30.0 kg/m^2
|
53 Participants
n=93 Participants
|
|
Open-label Baseline BMI (Body Mass Index) Group
>=30.0 kg/m^2
|
18 Participants
n=93 Participants
|
|
Open-label Baseline Waist Circumference (cm)
|
85.20 cm
STANDARD_DEVIATION 13.467 • n=93 Participants
|
|
Open-label Baseline BMI (Body Mass Index) (kg/m^2)
|
25.05 kg/m^2
STANDARD_DEVIATION 3.890 • n=93 Participants
|
|
Open-label Baseline Weight (kg)
|
75.32 kg
STANDARD_DEVIATION 13.987 • n=93 Participants
|
|
Open-label Baseline Height (cm)
|
173.1 cm
STANDARD_DEVIATION 7.73 • n=93 Participants
|
|
Double-blind Baseline Waist Circumference (cm)
|
85.36 cm
STANDARD_DEVIATION 13.508 • n=93 Participants
|
|
Double-blind Baseline BMI (Body Mass Index) (kg/m^2)
|
25.07 kg/m^2
STANDARD_DEVIATION 3.863 • n=93 Participants
|
|
Double-blind Baseline Weight (kg)
|
75.38 kg
STANDARD_DEVIATION 13.873 • n=93 Participants
|
|
Double-blind Baseline Height (cm)
|
173.1 cm
STANDARD_DEVIATION 7.73 • n=93 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug to last study visit (27 weeks)Number of Participants with overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation
Outcome measures
| Measure |
SEP-363856
n=156 Participants
SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily
|
SEP-SEP
Subjects who received SEP-363856 in study SEP361-201 and SEP-363856 in study SEP361-202
|
|---|---|---|
|
The Incidence of Overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation
Overall Adverse Events (AEs)
|
88 Participants
|
—
|
|
The Incidence of Overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation
Serious Adverse Events (SAEs)
|
15 Participants
|
—
|
|
The Incidence of Overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation
Adverse Events leading to discontinuation from study
|
18 Participants
|
—
|
|
The Incidence of Overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation
Adverse Events leading to discontinuation of study drug
|
18 Participants
|
—
|
SECONDARY outcome
Timeframe: Overall post Open-label Baseline treatment period (26 weeks)Number of participants with suicidal ideation (SI) and suicidal behavior (SB) using the Columbia - Suicide Severity Rating Scale (C-SSRS). The C-SSRS is a tool designed to systematically assess and track suicidal behavior and suicidal ideation for life time, one month prior to the screening visit for suicidal ideation and 6 months prior to the screening visit for suicidal behavior, and throughout the study. The strength of this suicide classification system is in its ability to comprehensively identify suicidal events while limiting the over-identification of suicidal behavior.
Outcome measures
| Measure |
SEP-363856
n=156 Participants
SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily
|
SEP-SEP
Subjects who received SEP-363856 in study SEP361-201 and SEP-363856 in study SEP361-202
|
|---|---|---|
|
Frequency of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)
Any suicidal ideation
|
3 Participants
|
—
|
|
Frequency of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)
Any suicidal behavior
|
1 Participants
|
—
|
|
Frequency of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)
Any suicidality
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Overall post Open-label Baseline treatment period (26 weeks)The C-SSRS is a tool designed to systematically assess and track suicidal behavior and suicidal ideation for life time, one month prior to the screening visit for suicidal ideation and 6 months prior to the screening visit for suicidal behavior, and throughout the study. The strength of this suicide classification system is in its ability to comprehensively identify suicidal events while limiting the over-identification of suicidal behavior.
Outcome measures
| Measure |
SEP-363856
n=156 Participants
SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily
|
SEP-SEP
Subjects who received SEP-363856 in study SEP361-201 and SEP-363856 in study SEP361-202
|
|---|---|---|
|
Severity of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)
SI: Wish to be dead
|
2 Participants
|
—
|
|
Severity of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)
SI: Non-specific active suicidal thoughts
|
2 Participants
|
—
|
|
Severity of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)
SI: Any methods (not plan) without intent to act
|
0 Participants
|
—
|
|
Severity of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)
SI: Some intent to act, without specific plan
|
0 Participants
|
—
|
|
Severity of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)
SI: Specific plan and intent
|
0 Participants
|
—
|
|
Severity of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)
SB: Preparatory acts or behavior
|
0 Participants
|
—
|
|
Severity of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)
SB: Aborted attempt
|
1 Participants
|
—
|
|
Severity of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)
SB: Interrupted attempt
|
0 Participants
|
—
|
|
Severity of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)
SB: Actual attempt (non-fatal)
|
0 Participants
|
—
|
|
Severity of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)
SB: Completed suicide
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From the time of clinical response to relapse or censor (one day after the last study drug dose)Population: Relapse population, which includes subjects who received at least one dose of open-label treatment and demonstrated a clinical response to 4 weeks of treatment with SEP-363856. Clinical response is defined as meeting (1) a decrease in PANSS total score of ≥ 20% from double-blind Baseline, AND (2) a CGI-S score ≤ 4. For PBO-SEP subjects, clinical response was evaluated at Week 4 of study SEP361-201. For SEP-SEP subjects, clinical response was evaluated at Week 4 of study SEP361-202.
Relapse is defined as the earliest occurrence of any of the following: - An increase in PANSS total score by ≥ 30% from the PANSS total score at clinical response and a CGI-S score ≥ 3; - Re-hospitalization for worsening of psychosis; - Emergence of suicidality, homicidality, and/or risk of harm to self or others.
Outcome measures
| Measure |
SEP-363856
n=59 Participants
SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily
|
SEP-SEP
n=51 Participants
Subjects who received SEP-363856 in study SEP361-201 and SEP-363856 in study SEP361-202
|
|---|---|---|
|
Time to Relapse During the 26-week Open-label Treatment Period for Subjects Who Demonstrated a Clinical Response to 4 Weeks of Treatment With SEP-363856
|
NA Days
insufficient number of participants with events
|
NA Days
insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From the time of clinical response to relapse or censor (one day after the last study drug dose)Population: Relapse population, which includes subjects who received at least one dose of open-label treatment and demonstrated a clinical response to 4 weeks of treatment with SEP-363856. Clinical response is defined as meeting (1) a decrease in PANSS total score of ≥ 20% from double-blind Baseline, AND (2) a CGI-S score ≤ 4. For PBO-SEP subjects, clinical response was evaluated at Week 4 of study SEP361-201. For SEP-SEP subjects, clinical response was evaluated at Week 4 of study SEP361-202.
Relapse is defined as the earliest occurrence of any of the following: - An increase in PANSS total score by ≥ 30% from the PANSS total score at clinical response and a CGI-S score ≥ 3; - Re-hospitalization for worsening of psychosis; - Emergence of suicidality, homicidality, and/or risk of harm to self or others.
Outcome measures
| Measure |
SEP-363856
n=59 Participants
SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily
|
SEP-SEP
n=51 Participants
Subjects who received SEP-363856 in study SEP361-201 and SEP-363856 in study SEP361-202
|
|---|---|---|
|
Rate of Relapse During the 26-week Open-label Treatment Period for Subjects Who Demonstrated a Clinical Response to 4 Weeks of Treatment With SEP-363856
|
12 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Double-blind Baseline (DB BLN), Open-label Baseline (OL BLN), Week 26 (Wk 26)Population: Subjects with PANSS data missing at a particular time point did not contribute to the summary for that time point.
PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210.
Outcome measures
| Measure |
SEP-363856
n=156 Participants
SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily
|
SEP-SEP
Subjects who received SEP-363856 in study SEP361-201 and SEP-363856 in study SEP361-202
|
|---|---|---|
|
Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology)
Total Score: DB BLN Observed
|
101.5 Units on a scale
Standard Deviation 7.99
|
—
|
|
Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology)
Total Score: OL BLN Observed
|
83.1 Units on a scale
Standard Deviation 15.03
|
—
|
|
Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology)
Total Score: Wk 26 Observed
|
59.3 Units on a scale
Standard Deviation 12.45
|
—
|
|
Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology)
Total Score: Chg from DB BLN at Wk 26
|
-41.8 Units on a scale
Standard Deviation 13.98
|
—
|
|
Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology)
Total Score: Chg from OL BLN at Wk 26
|
-22.6 Units on a scale
Standard Deviation 15.48
|
—
|
|
Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology)
Positive SS: DB BLN Observed
|
25.7 Units on a scale
Standard Deviation 3.22
|
—
|
|
Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology)
Positive SS: OL BLN Observed
|
19.8 Units on a scale
Standard Deviation 4.96
|
—
|
|
Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology)
Positive SS: Wk 26 Observed
|
12.2 Units on a scale
Standard Deviation 3.72
|
—
|
|
Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology)
Positive SS: Chg from DB BLN at Wk 26
|
-13.5 Units on a scale
Standard Deviation 4.75
|
—
|
|
Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology)
Positive SS: Chg from OL BLN at Wk 26
|
-7.3 Units on a scale
Standard Deviation 5.37
|
—
|
|
Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology)
Negative SS: DB BLN Observed
|
25.4 Units on a scale
Standard Deviation 4.03
|
—
|
|
Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology)
Negative SS: OL BLN Observed
|
22.3 Units on a scale
Standard Deviation 4.38
|
—
|
|
Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology)
Negative SS: Wk 26 Observed
|
17.2 Units on a scale
Standard Deviation 4.10
|
—
|
|
Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology)
Negative SS: Chg from DB BLN at Wk 26
|
-8.4 Units on a scale
Standard Deviation 4.48
|
—
|
|
Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology)
Negative SS: Chg from OL BLN at Wk 26
|
-5.2 Units on a scale
Standard Deviation 4.20
|
—
|
|
Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology)
Gen-Psychopathology SS: DB BLN Observed
|
50.4 Units on a scale
Standard Deviation 5.01
|
—
|
|
Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology)
Gen-Psychopathology SS: OL BLN Observed
|
41.1 Units on a scale
Standard Deviation 7.93
|
—
|
|
Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology)
Gen-Psychopathology SS: Wk 26 Observed
|
30.0 Units on a scale
Standard Deviation 6.77
|
—
|
|
Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology)
Gen-Psychopathology SS: Chg from DB BLN at Wk 26
|
-19.9 Units on a scale
Standard Deviation 7.86
|
—
|
|
Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology)
Gen-Psychopathology SS: Chg from OL BLN at Wk 26
|
-10.2 Units on a scale
Standard Deviation 8.31
|
—
|
SECONDARY outcome
Timeframe: Double-blind (DB) Baseline, Open-label (OL) Baseline, Week 26Population: Subjects with CGI-S score data missing at a particular time point did not contribute to the summary for that time point.
The CGI-S is a single-item clinician-rated assessment of the subject's current illness state on a 7-point scale (score range: 1-7), where a higher score is associated with greater illness severity.
Outcome measures
| Measure |
SEP-363856
n=156 Participants
SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily
|
SEP-SEP
Subjects who received SEP-363856 in study SEP361-201 and SEP-363856 in study SEP361-202
|
|---|---|---|
|
Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Clinical Global Impression - Severity (CGI-S) Score
CGI-S Score: DB Baseline Observed
|
5.0 Units on a scale
Standard Deviation 0.42
|
—
|
|
Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Clinical Global Impression - Severity (CGI-S) Score
CGI-S Score: OL Baseline Observed
|
4.0 Units on a scale
Standard Deviation 0.84
|
—
|
|
Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Clinical Global Impression - Severity (CGI-S) Score
CGI-S Score: Week 26 Observed
|
3.0 Units on a scale
Standard Deviation 0.74
|
—
|
|
Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Clinical Global Impression - Severity (CGI-S) Score
CGI-S Score: Change from DB Baseline at Week 26
|
-2.0 Units on a scale
Standard Deviation 0.82
|
—
|
|
Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Clinical Global Impression - Severity (CGI-S) Score
CGI-S Score: Change from OL Baseline at Week 26
|
-1.0 Units on a scale
Standard Deviation 0.91
|
—
|
SECONDARY outcome
Timeframe: Double-blind (DB) Baseline, Open-label (OL) Baseline, Week 26Population: Subjects with BNSS total score data missing at a particular time point did not contribute to the summary for that time point.
The BNSS is a rating scale to measure the current level of severity of negative symptoms in schizophrenia and schizoaffective disorder. The measure is comprised of 13 individual items organized in 6 subscales. The 13 individual items provide a composite total score (ranging from 0 to 78). Each of the items are scored on a Likert-type 7-point scale from 0 - 6, where values of 0 indicates symptom is absent and a value of 6 means the symptom is a severe form.
Outcome measures
| Measure |
SEP-363856
n=156 Participants
SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily
|
SEP-SEP
Subjects who received SEP-363856 in study SEP361-201 and SEP-363856 in study SEP361-202
|
|---|---|---|
|
Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Brief Negative Symptom Scale (BNSS) Total Score
Total Score: DB Baseline Observed
|
38.4 Units on a scale
Standard Deviation 11.94
|
—
|
|
Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Brief Negative Symptom Scale (BNSS) Total Score
Total Score: OL Baseline Observed
|
33.0 Units on a scale
Standard Deviation 11.41
|
—
|
|
Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Brief Negative Symptom Scale (BNSS) Total Score
Total Score: Week 26 Observed
|
22.5 Units on a scale
Standard Deviation 11.83
|
—
|
|
Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Brief Negative Symptom Scale (BNSS) Total Score
Total Score: Change from DB Baseline at Week 26
|
-16.8 Units on a scale
Standard Deviation 12.42
|
—
|
|
Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Brief Negative Symptom Scale (BNSS) Total Score
Total Score: Change from OL Baseline at Week 26
|
-11.3 Units on a scale
Standard Deviation 9.69
|
—
|
SECONDARY outcome
Timeframe: Double-blind (DB) Baseline, Open-label (OL) Baseline, Week 26Population: Subjects with MADRS total score data missing at a particular time point did not contribute to the summary for that time point.
The MADRS is a clinician-rated assessment of the subject's level of depression. The measure contains 10 items that measure apparent and reported sadness, inner tension, reduced sleep and appetite, difficulty concentrating, lassitude, inability to feel, and pessimistic and suicidal thoughts. Each item is scored in a range of 0 to 6 points, with higher scores indicating increased depressive symptoms. Total score will be equal to the sum of the 10 items (range between 0 and 60).
Outcome measures
| Measure |
SEP-363856
n=156 Participants
SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily
|
SEP-SEP
Subjects who received SEP-363856 in study SEP361-201 and SEP-363856 in study SEP361-202
|
|---|---|---|
|
Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Total Score: DB Baseline Observed
|
12.6 Units on a scale
Standard Deviation 7.25
|
—
|
|
Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Total Score: OL Baseline Observed
|
9.2 Units on a scale
Standard Deviation 6.33
|
—
|
|
Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Total Score: Week 26 Observed
|
4.4 Units on a scale
Standard Deviation 4.72
|
—
|
|
Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Total Score: Change from DB Baseline at Week 26
|
-8.1 Units on a scale
Standard Deviation 6.44
|
—
|
|
Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Total Score: Change from OL Baseline at Week 26
|
-4.5 Units on a scale
Standard Deviation 5.28
|
—
|
SECONDARY outcome
Timeframe: Week 26Population: Subjects who received at least one dose of open-label treatment and had PANSS total score data available at Double-blind Baseline and Week 26 are included in analysis.
PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210.
Outcome measures
| Measure |
SEP-363856
n=53 Participants
SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily
|
SEP-SEP
n=51 Participants
Subjects who received SEP-363856 in study SEP361-201 and SEP-363856 in study SEP361-202
|
|---|---|---|
|
Proportion of Subjects Who Achieved a Response, Defined as a 20% or Greater Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score From Double-blind Baseline of Study SEP361-201
|
52 Participants
|
49 Participants
|
Adverse Events
SEP-363856
Serious adverse events
| Measure |
SEP-363856
n=156 participants at risk
SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily
|
|---|---|
|
Psychiatric disorders
Acute psychosis
|
0.64%
1/156 • Number of events 1 • From first dose of study drug to last study visit (27 weeks)
|
|
Psychiatric disorders
Depression
|
0.64%
1/156 • Number of events 1 • From first dose of study drug to last study visit (27 weeks)
|
|
Psychiatric disorders
Psychotic disorder
|
0.64%
1/156 • Number of events 1 • From first dose of study drug to last study visit (27 weeks)
|
|
Psychiatric disorders
Schizophrenia
|
7.1%
11/156 • Number of events 11 • From first dose of study drug to last study visit (27 weeks)
|
|
Psychiatric disorders
Suicidal ideation
|
0.64%
1/156 • Number of events 1 • From first dose of study drug to last study visit (27 weeks)
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.64%
1/156 • Number of events 1 • From first dose of study drug to last study visit (27 weeks)
|
Other adverse events
| Measure |
SEP-363856
n=156 participants at risk
SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily
|
|---|---|
|
Nervous system disorders
Headache
|
11.5%
18/156 • Number of events 36 • From first dose of study drug to last study visit (27 weeks)
|
|
Psychiatric disorders
Anxiety
|
5.1%
8/156 • Number of events 36 • From first dose of study drug to last study visit (27 weeks)
|
|
Psychiatric disorders
Insomnia
|
8.3%
13/156 • Number of events 24 • From first dose of study drug to last study visit (27 weeks)
|
|
Psychiatric disorders
Schizophrenia
|
6.4%
10/156 • Number of events 12 • From first dose of study drug to last study visit (27 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER