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.
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.
Intranasal ketamine hydrochloride, four administrations at three-day intervals; weight‑based dosing with titration.
Intranasal. 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. Titration based on side effects and response (up to 80% improvement criteria).
Intranasal placebo (flat tonic water), four administrations at three-day intervals; weight‑based volumes.
Flat tonic water (e.g., Canada Dry); intranasal volumes weight-based (0.1–0.4 ml or 0.2–1.2 ml by weight group).