Schizophrenia
Conditions
Keywords
Schizophrenia
Brief summary
This study evaluated how well SEP-363856 works and how safe it is in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication.
Detailed description
This was an 8-week, outpatient, multicenter, open-label, single-group, flexible-dose study. Following a screening period of up to 21 days, eligible participants took part in the study. In the 8-week treatment period, participants were treated with SEP-363856 while continuing to take the full dose of their pre-switch antipsychotic. After the end of the treatment period, participants were required to complete the follow-up visit, 7 days after the last dose of SEP-363856.
Interventions
DRUGSEP-363856
SEP-363856 flexibly dosed for 8 weeks.
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
This list is not all inclusive * Participants meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a diagnosis of schizophrenia. * Participants are judged to be clinically stable (ie, no evidence of an acute exacerbation of schizophrenia) by the Investigator for at least 8 weeks prior to Baseline. * Participants must be judged by the Investigator to be an appropriate candidate for switching current antipsychotic medication due to safety or tolerability concerns and/or insufficient efficacy. * Participants are taking an oral antipsychotic and the antipsychotic regimen has been stable for at least 6 weeks prior to Screening.
Exclusion criteria
This list is not all inclusive * Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a major psychiatric disorder, other than schizophrenia, that is the primary focus of treatment. * Participants are at significant risk of harming self or others based on investigator's judgment. * Participant has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the participant's ability to complete and/or participate in the study. * Female participant who is pregnant or lactating. * Participant tests positive for drugs of abuse at Screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Discontinued From the Study Due to Clinical Reasons | From the first dose of the study drug up to end of follow up (up to Week 9) | Discontinuation for clinical reasons was defined as reasons due to adverse event (AE) or lack of efficacy. AEs are defined as untoward medical occurrences that started at the same time of or after the first dose of study drug. The percentage of participants who discontinued for clinical reasons was calculated by a proportion consisting of the number of participants who experience a discontinuation event due to clinical reasons as the numerator divided by the number of participants in the safety population as the denominator multiplied by 100 along with a corresponding 95% confidence interval (CI). 95% CI was calculated using the normal approximation method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Discontinued From the Study Due to Any Reason | From first dose of the study drug up to end of follow-up period (up to Week 9) | The percentage of participants who discontinued from the study due to any reason was calculated by a proportion consisting of the number of participants who experience a discontinuation event due to any reason as the numerator divided by the number of participants in the safety population as the denominator multiplied by 100 along with a corresponding 95% CI. 95% CI was calculated using the normal approximation method. |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 26 clinical sites in the United States (US) from 19 December 2022 to 01 April 2024.
Pre-assignment details
A total of 243 participants were screened, of which 101 participants entered the study, and all 101 participants received at least one dose of SEP-363856 in the 8-week treatment period.
Participants by arm
| Arm | Count |
|---|---|
| SEP-363856 Participants received flexible doses of SEP-363856 50 to 100 mg/day, orally, QD up to Week 8. The dose was titrated up from 50 mg/day on Days 1 to 3, to 75 mg/day on Days 4 to 7. Beginning Day 8, the dose was adjusted within the range of 50 mg/day to 100 mg/day in 25 mg increments (i.e. 50, 75, or 100 mg/day) up to Week 8. | 101 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Non-Compliance With Study Drug | 4 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | SEP-363856 |
|---|---|
| Age, Continuous | 48.1 years STANDARD_DEVIATION 12.02 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 83 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 64 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 32 Participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 101 |
| other Total, other adverse events | 13 / 101 |
| serious Total, serious adverse events | 4 / 101 |
Outcome results
Primary
Percentage of Participants Who Discontinued From the Study Due to Clinical Reasons
Discontinuation for clinical reasons was defined as reasons due to adverse event (AE) or lack of efficacy. AEs are defined as untoward medical occurrences that started at the same time of or after the first dose of study drug. The percentage of participants who discontinued for clinical reasons was calculated by a proportion consisting of the number of participants who experience a discontinuation event due to clinical reasons as the numerator divided by the number of participants in the safety population as the denominator multiplied by 100 along with a corresponding 95% confidence interval (CI). 95% CI was calculated using the normal approximation method.
Time frame: From the first dose of the study drug up to end of follow up (up to Week 9)
Population: Safety population included all participants that were enrolled and received the study drug. Percentages are rounded off to the nearest decimal point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SEP-363856 | Percentage of Participants Who Discontinued From the Study Due to Clinical Reasons | 7.9 percentage of participants |
Secondary
Percentage of Participants Who Discontinued From the Study Due to Any Reason
The percentage of participants who discontinued from the study due to any reason was calculated by a proportion consisting of the number of participants who experience a discontinuation event due to any reason as the numerator divided by the number of participants in the safety population as the denominator multiplied by 100 along with a corresponding 95% CI. 95% CI was calculated using the normal approximation method.
Time frame: From first dose of the study drug up to end of follow-up period (up to Week 9)
Population: Safety population included all participants that were enrolled and received the study drug. Percentages are rounded off to the nearest decimal point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SEP-363856 | Percentage of Participants Who Discontinued From the Study Due to Any Reason | 17.8 percentage of participants |