Intra-Cellular Therapies, Inc.
The purpose of this study is to assess how safe ITI-1284 is and how well it can be tolerated in long-term, when given alone or with other medicines, in participants with generalized anxiety disorder (GAD) who have not responded to treatment previously. GAD is a mental health condition defined by constant, uncontrollable worry about everyday things that lasts for six months or more.
Inclusion criteria for Roll-over participants: * Provide written informed consent before the initiation of any study specific procedures * Is currently an outpatient, and is anticipated to maintain outpatient status for the duration of the study * Male or female of childbearing potential and agrees to use a highly effective method of birth control from the time informed consent is provided until 30 days after the last dose of ITI-1284 for females and 90 days after the last dose of ITI-1284 for males * Ability to follow study instructions and likely to complete all required visits * In the opi…
ITI-1284 will be administered sublingually.
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