Skip to main content

Table 1 Schedule of Events

From: Evaluation of the efficacy and safety of olanzapine as an adjunctive treatment for anorexia nervosa in adolescent females: a randomized, double-blind, placebo-controlled trial

Timelines + 3 days Day -7 Day 0 Day 7 Day 14 Day 21 Day 28 Day 35 Day 42 Day 49 Day 56 Day 63 Day 70 Day 77 Day 84 Day 91 Day 98 Day 105 Day 280+ 7
VISIT Screen Week 0 Rand Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 11 Week 12 Week 13 Week 14 Week 15 or Term Week 40 F/UP
Informed Consent x                  
Medical History x                  
Demographics x                  
Inclusion/Exclusion x x                 
Height x              x     x
Weight & BMI score x x x x x x x x x x x x x x x x x x
Physical Exam x                 x  
Randomization   x                 
Vital Signs x x x x x x x x x x x x x x x x x x
Hematology & Chemistry* x    x   x     x     x    x  
HBA1C     x              x  
Multistick Urinalysis x x x x x x x x x x x x x x x x x  
Urine for Pregnancy x x x x x x x x x x x x x x x x x  
Electrocardiogram (EKG) x    x   x            x  
Adverse Events    x x x x x x x x x x x x x x x x
Concomittant Meds (mg) x 1.25 → 2.5 5 7.5 7.5 7.5 7.5 7.5 7.5 7.5 7.5 7.5 7.5 5.0 2.5 0 0 0
Dispense Study Med   x x x x x x x x x x x x x x    
AIMS    x x x x x x x x x x x x x x x  
Psychological Measures                   
EAT-26   x       x       x    x x
CDI **   x       x       x    x x
MASC **   x       x       x    x x
CAPI   x       x       x    x x
CBCL**   x       x       x    x x
EDS3   x       x       x    x x
  1. *namely CBC and diff, electrolytes, Mg, Ca, P04, BUN, Cr, fasting glucose, Albumin, Ferritin, vit.B12, RBC folate, FSH, LH, estradiol, prolactin, βHCG, TSH, INR, cholesterol and triglycerides, ALT, AST and Alk. Phos. If more than 2 weeks have elapsed between Screen labs and Baseline (week 0), repeat Screen labs work prior to or at Baseline Visit (with the exception of bone mineral density)
  2. ** If CDI, MASC and CBCL have been completed at Screen Visit and it is < 2 weeks, these measures may not be repeated at week zero.
\