Dumpster Fire, page-43

I think it's pretty simple. Look for the PAS vs placebo and the Clinical Global Impression Scale vs placebo in the results. 40 patients isn't powered enough to prove anything, but if the drug works you should still see a significant affect in the percentages.

BNC210: AGITATION IN THE ELDERLY (PHASE 2) - ONGOING
The trial, designed for short treatment and rapid recruitment, will evaluate the effect of BNC210 on the resolution of agitation in hospitalised elderly patients and assess the safety and tolerability of BNC210 in this patient population. It will recruit approximately 40 elderly patients in specialist geriatric hospital wards across Australia, and is a randomised, double-blind, placebo-controlled design with a 5-day treatment period.

Objectives:
Primary
- To assess safety and tolerability of BNC210 in hospitalised elderly patients with agitation
- To compare the effect of BNC210 and placebo on agitation in hospitalised elderly patients as measured by the Pittsburgh Agitation Scale (PAS)
Secondary
- To compare the effect of BNC210 and placebo on global function in hospitalised elderly patients as assessed by the Clinical Global Impression Scale
Exploratory
- To obtain preliminary estimates of pharmacokinetics of BNC210 in elderly patients

The Pittsburgh Agitation Scale (PAS)
• Measures 4 dimensions of agitated behavior
• Each dimension is rated from 0-4
– 0 represents normal or absent behavior, 4 represents extreme example of agitated behavior
Score is added for a total of 16 possible points
• Aberrant Vocalization
– Crying, shouting, inappropriate communication
• Motor Agitation
– Pacing, rate of movement, exit seeking
• Aggression
– Threats, physical violence
• Resistance to Care
– Procrastination, refusal, striking out during care

The Clinical Global Impression – Efficacy Index is a 4×4 rating scale that assesses the therapeutic effect of treatment with psychiatric medication and associated side effects.

Therapeutic effect
- Marked — Vast improvement. Complete or nearly complete remission of all symptoms
- Moderate — Decided improvement. Partial remission of symptoms
- Minimal — Slight improvement which doesn't alter status of care of patient
- Unchanged or worse

Side effects
- None
- Do not significantly interfere with patient's functioning
- Significantly interfere with patient's functioning
- Outweigh therapeutic effect