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
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