Primary outcome [1] - Change in Clinical Global Impression Scale...

Primary outcome [1] - Change in Clinical Global Impression Scale -Improvement (CGI-I)This is a 7-point scale measuring symptom change from baseline

Primary outcome 2 - Change in Vineland Adaptive Behaviour Scales, Third Edition (Vineland-3) Parent/Caregiver Form.Used to measure adaptive functioning across three core domains (Communication, Daily Living Skills, and Socialization), and two optional domains (Motor Skills and Maladaptive Behaviour); items are rated on a 3-point scale (0=never; 1=sometimes; 2=usually or often). The core domains sum to a total Adaptive Behaviour Composite.

There are Many secondary outcomes / measures. Very comprehensive so gives (me) an understanding of why it takes so long to compile the results and understand drivers for any outliers. There will be a cornucopia of other data collected against the above measures for other trials to compare to. Also blood as youve mentioned, liver and renal tests for safety.

All the detail here: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=381885&isReview=true although updating the CTR site isnt one of NTI or Fenix's strong points.

GLAH