Table 1.

Pediatric Depression Studies Currently Recruiting.

No NCT # Abbreviated Study Title Age (y) # Pts/Centers
1 NCT03395353 Long-term S study of duloxetine hydrochloride in Japanese children and adolescents with depressive disorder 9–17 100/?
2 NCT03315793 DB S&E study of duloxetine hydrochloride versus placebo in Japanese children and adolescents with depressive disorder 9–17 148/?
3 NCT03665038 MC, DB, PC study on E, S, T, PK of brexanolone in adolescent female subjects with postpartum depression 15–17 80/13
4 NCT02709655 Interventional, R, DB, PC active reference (fluoxetine) fixed-dose study of vortioxetine in pts 7–11 y with MDD 7–11 600/133
5 NCT03569475 DB, PAC, S&E levomilnacipran ER study in pts 7–17 y with MDD 7–17 480/46
6 NCT02431806 DB, PAC, S&E levomilnacipran ER study in pts with MDD 12–17 660/91
7 NCT03185819 DB, R psychoactive PC, E&S study of 3 doses of IN esketamine plus comprehensive SoC for rapid symptom reduction of MDD, including suicidal ideation, in imminent risk for suicide 12–17 145/56

DB, double blind; E, efficacy; ER, extended release; IN, intranasal; MC, multicenter; MDD, major depressive disorder; NCT#, national clinical trial # in www.clinicaltrials.gov; PAC, placebo- and active controlled; PC, placebo-controlled; PK, pharmacokinetics; pts, patients; R, randomized; S, safety; S&E, safety and efficacy; SoC, standard of care; T, tolerability; y, year.

RMMJ Rambam Maimonides Medical Journal Rambam Health Care Campus 2019 October; 10(4): e0026. ISSN: 2076-9172
Published online 2019 October 29. doi: 10.5041/RMMJ.10374.