Intranasal Ketamine In the Treatment of Pediatric Bipolar Disorder
Randomized, parallel Phase II/III study (n=5) of intranasal ketamine (Ketalar) vs placebo in children aged 6–12 with treatment‑resistant pediatric bipolar disorder (Fear of Harm phenotype); four intranasal administrations at three‑day intervals.
Details
Randomized, triple‑blind, parallel trial comparing intranasal ketamine hydrochloride (Ketalar) with intranasal placebo in children aged 6–12 with DSM‑IV bipolar presentations including the Fear of Harm phenotype; four administrations given every three days.
Dosing is weight‑based with titration: Group A (20–40 kg) initial 10 mg (≈0.25–0.5 mg/kg), max 40 mg; Group B (40.01–100 kg) initial 20 mg (≈0.20–0.5 mg/kg), max 120 mg. Outcomes include safety, tolerability, and efficacy measures (YMRS, YBOCS); titration depends on side effects and improvement from baseline.