The FDA requires that all antidepressant drugs display a black box warning describing the potential for increased suicidal thinking and behavior when prescribed to children and adolescents with MDD and other psychiatric disorders. In short-term clinical trials, the suicide risk occurred twice as frequently with antidepressant-treated children/adolescents compared to those receiving placebo (4% vs. 2%, respectively) in the first few months of treatment. Pediatric patients prescribed antidepressant drugs should be closely monitored for changes in behavior.

Maximum recommended doses for non-SSRI antidepressants approved for use as monotherapy in pediatric patients are summarized in Tables 8-10. An additional column reflecting literature-based dosing included in the Texas Health and Human Services Psychotropic Medication Utilization Parameters for Children and Youth in Texas Public Behavioral Health (6th Version) is included in Tables 8-11. Dosages exceeding these recommendations will be reviewed.

Table 8: Pediatric Maximum Recommended Antidepressant Drug Dosages (Monotherapy) - Tricyclic Antidepressants^{1-2, 3-4, 6-9, 12-18, 44}

Drug Name	Available Dosage Strengths	Treatment Indication	Literature Based Maximum Dosage	FDA Approved Maximum Recommended Dosage
amitriptyline (generics)	generics: 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg tablets	MDD	Reviewed but not included/ recommended	Greater than 12 years of age: 50 mg daily divided into three doses^
clomipramine (Anafranil®, generics)	25 mg, 50 mg 75 mg capsules	OCD	Age 10-17 years: 3 mg/kg/day or 200 mg/ day, whichever is less	Greater than or equal to 10 years of age: 3 mg/kg/day or 200 mg/day, whichever is less
desipramine (Norpramin®, generics)	generics: 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg tablets Norpramin®: 10 mg, 25 mg tablets	aa	Reviewed but not included/ recommended	adolescents:   150 mg/day
imipramine (Tofranil®, generics)	generics:10 mg, 25 mg, 50 mg tablets; Tofranil®: 10 mg, 25 mg, 50 mg tablets	MDD	Reviewed but not included/ recommended	adolescents: 100 mg/day
		nocturnal enuresis		6-11 years of age: 2.5 mg/kg/day up to 50 mg/day Greater than or equal to 12 years of age: 2.5 mg/kg/day up to 75 mg/day
nortriptyline (Pamelor®, generics)	10 mg, 25 mg, 50 mg, 75 mg capsules; 10 mg/5 mL oral solution (generic only)	MDD	Reviewed but not included/ recommended	adolescents: 50 mg/day
protriptyline	5 mg, 10 mg tablets	MDD	Reviewed but not included/ recommended	adolescents:   30 mg/day*
trimipramine (generics)	25 mg, 50 mg 100 mg capsules	MDD	Reviewed but not included/recommended	adolescents:   100 mg/day

Legend:

• MDD = major depressive disorder
• OCD = obsessive-compulsive disorder
• ^ In general, lower dosages are recommended for these patients. Ten milligrams 3 times daily with 20 mg at bedtime may be satisfactory in adolescent and elderly patients who do not tolerate higher dosages.
• # imipramine pamoate is not approved for pediatric use
• * Adolescents should usually be given lower than average protriptyline doses

Table 9: Pediatric Maximum Recommended Antidepressant Drug Dosages (Monotherapy)– Monoamine Oxidase Inhibitors^{1-2, 21, 24, 44}

Drug Name	Available Dosage Strengths	Treatment Indication	Literature Based Maximum Dosage	FDA Approved Maximum Recommended Dosage
isocarboxazid (Marplan®)	10 mg tablets	MDD	Not reviewed	Greater than or equal to 16 years of age:   60 mg/day
selegiline (EMSAM®) transdermal patch	6 mg/ 24 hours, 9 mg/ 24 hours, 12 mg/ 24 hours transdermal patch	MDD	Age ≥ 12 years: 12 mg per 24 hours	Not approved for pediatric use

Legend:

• MDD = major depressive disorder

Table 10: Pediatric Maximum Recommended Antidepressant Drug Dosages (Monotherapy) – Serotonin and Norepinephrine Reuptake Inhibitors^{1-2, 26-28, 44}

	Drug Name	Available Dosage Strengths	Treatment Indication	Literature Based Maximum Dosage	FDA Approved Maximum Recommended Dosage
	desvenlafaxine (Pristiq®, generics)	25 mg, 50 mg 100 mg 24-hour ER tablets	Major depressive disorder	Age 7-17 years: 50 mg/day	Not approved for pediatric use
	duloxetine (Cymbalta®, generics)	20 mg, 30 mg, 40 mg 60 mg delayed-release capsules	General anxiety disorder	Age 7-17 years: 120 mg/day	7-17 years of age:   120 mg/day
			Fibromyalgia		13 years of age: 60 mg/ day

Table 11: Pediatric Maximum Recommended Antidepressant Drug Dosages (Monotherapy) - Tetracyclic Antidepressants ^{1-2, 19-20, 44}

Drug Name	Available Dosage Strengths	Treatment Indication	Literature Based Maximum Dosage	FDA Approved Maximum Recommended Dosage
mirtazapine (Remeron®, generics)	7.5 mg, 15 mg, 30 mg, 45 mg tablets; 15 mg, 30 mg, 45 mg orally disintegrating tablets	Major depressive disorder	Age greater than or equal to 3 years: 45 mg/day	Not approved for pediatric use