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

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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

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.

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
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Lake Charles, Louisiana 70629
Phone: 337-564-6405
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811 Juniper St NE
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...
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Dallas, Texas 75243
Phone: 214-396-4844
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Gyongyos,
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Little Rock, Arkansas 72211
Phone: 501-222-9052
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Little Rock, AR
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Pico Rivera, California 90660
Phone: 562-928-8601
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Pico Rivera, CA
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