Planned Duration of Study and Visit Windows Sample Clauses

Planned Duration of Study and Visit Windows. Subjects enrolled in this study will fall into two categories that will determine the duration of the study. These include the follow-up portion of the study, which encompasses 12 months after the final experimental session. • Full dose subjects completing Stage 1 only: 15 months • Comparator dose subjects who complete Stage 2: 18 months Screening may take up to two months, with the baseline CAPS being conducted no more than 8 weeks before the first experimental session, leaving room for appropriate medication washout of at least 5 half-lives of pre-study psychiatric medications and active metabolites, and one additional week for stabilization. For example, the maximum washout would be 7 weeks for subjects tapering off of fluoxetine plus one week for stabilization. Preparatory sessions should be scheduled approximately one week apart, with the first experimental session taking place 3-5 weeks after enrollment, and at most 8 weeks after the baseline CAPS. The maximum window from the start of screening to the first experimental session is 13 weeks. The optimal timing for Stage 2 is one month after the primary endpoint visit in Stage 1, with a maximum allowable window of five months. Any delay between visits would result in a corresponding extension of study duration.
Sample 1
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