Last updated on February 2019

An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Schizophrenia
  • Age: Between 18 - 40 Years
  • Gender: Male or Female

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.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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