An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia
Status: | Completed |
---|---|
Conditions: | Schizophrenia |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 40 |
Updated: | 2/7/2019 |
Start Date: | January 31, 2017 |
End Date: | January 29, 2019 |
A 26-Week Open-label Safety and Tolerability Extension Study of SEP-363856 in Adult Subjects With Schizophrenia
An extension study of safety and tolerability of SEP-363856 in adult subjects with
schizophrenia
schizophrenia
This is a 26 week, multiregional, open-label extension study designed to evaluate the
long-term safety and tolerability of SEP-363856 for the treatment of subjects with
schizophrenia who have completed the 4 week double-blind treatment phase of Study SEP361-201.
No statistical hypothesis tests will be performed.
long-term safety and tolerability of SEP-363856 for the treatment of subjects with
schizophrenia who have completed the 4 week double-blind treatment phase of Study SEP361-201.
No statistical hypothesis tests will be performed.
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.
We found this trial at
6
sites
Click here to add this to my saved trials
811 Juniper St NE
Atlanta, Georgia 30308
Atlanta, Georgia 30308
(404) 881-5800
Phone: 404-881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
Click here to add this to my saved trials
Gyongyos, Dózsa György
Phone: +3612108139
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials