Effect of a Hypocretin/Orexin Antagonist on Neurocognitive Performance
Abstract
During Year 4, revisions were made to the protocol which allowed female participants to be dosed within either phase of the menstrual cycle so long as they do not meet criteria for Premenstrual Dysphoric Disorder and/or moderate to severe Premenstrual Syndrome. Likewise, modifications to recruitment materials and compensation schedules have increased enrollment and retention. Safety reports continue to be sent to Actelion on a monthly basis. Both blinded and unblinded monitoring visits of study procedures and facilities are ongoing. Throughout Year 4, many new study team members were hired and trained (Study Coordinator, Recruiter, and Research Assistant). The study team also expanded to include additional informed consent administrators, clinical interviewers, as well as sleep technicians and neuropsychological assessment administrators in order to reach the our quarterly enrollment goals. Enrollment is expected to increase due to the actions taken above.
Document Details
- Document Type
- Technical Report
- Publication Date
- Dec 18, 2013
- Accession Number
- ADA594480
Entities
People
- Thomas Neylan
Organizations
- Northern California Institute for Research and Education