Phase 2
Completed N=157
An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia
Source: ClinicalTrials.gov NCT02970929 ↗Enrolled (actual)
157
Serious AEs
9.6%
Results posted
Feb 2022
Primary outcomePrimary: The Incidence of Overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation — 88; 15; 18; 18 Participants
Summary
An extension study of safety and tolerability of SEP-363856 in adult subjects with schizophrenia
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Incidence of Overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation |
88; 15; 18; 18 | — |
| SECONDARY Frequency of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS) |
3; 1; 3 | — |
| SECONDARY Severity of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS) |
2; 2; 0; 0; 0; 0 | — |
| SECONDARY 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; NA | — |
| SECONDARY 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; 11 | — |
| SECONDARY 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) |
101.5; 83.1; 59.3; -41.8; -22.6; 25.7 | — |
| SECONDARY 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 |
5.0; 4.0; 3.0; -2.0; -1.0 | — |
| SECONDARY 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 |
38.4; 33.0; 22.5; -16.8; -11.3 | — |
| SECONDARY 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 |
12.6; 9.2; 4.4; -8.1; -4.5 | — |
| SECONDARY 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; 49 | — |
Eligibility Criteria
Inclusion Criteria
Subject must give written informed consent and privacy authorization prior to participation in the study and able to comply with the protocol, in the opinion of the investigator.
- Subject has completed Study SEP361 201 through Week 4
- Subject has not taken any medication other than the study drug for the purpose of controlling schizophrenia symptoms during Study SEP361 201.
- Female subject must have a negative urine pregnancy test at Visit 7 of Study SEP361 201; females who are post-menopausal (defined as at least 12 months of spontaneous amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will be exempted from the pregnancy test.
- Male subjects with female partner(s) of childbearing potential must agree to avoid fathering a child and use acceptable methods of birth control from screening until at least 30 days after the last study drug administration
Exclusion Criteria
- Subject answers "yes" to "suicidal ideation" Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at Visit 7 of Study SEP361 201. Subjects who answer "yes" to this question must be referred to the Investigator for follow up evaluation.
- Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory test at Visit 7 of Study SEP361 201 that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study.
- Subject has a positive urine drug screen (UDS) or breath alcohol test at Visit 7 of Study SEP361 201.
- Subject is pregnant or lactating.
- Subject is at high risk of non-compliance in the Investigator's opinion.
- Subject is in the opinion of the Investigator, unsuitable in any other way to participate in this study.
Data sourced from ClinicalTrials.gov (NCT02970929). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.