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. 2017 Apr 6;15(2):144–156. doi: 10.1176/appi.focus.20160047

TABLE 2.

Randomized Controlled Trials of Selective Serotonin Reuptake Inhibitors and Serotonin-Norepinephrine Reuptake Inhibitors for Child and Adolescent Anxiety Disordersa

Dose (mg/day)
Treatment studied Diagnosis Duration (weeks) N Range Average FDA indication (age 12–17) Adverse events
Walkup et al., 2008 (74) GAD, SoP, SAD 12 25–200 133.7±59.8 OCD (50–200 mg/day)b No suicide attempts, no significantly greater rate of adverse events in sertraline vs. placebo group
 Sertraline 133
 CBT 139
 Combination 140
 Placebo 76
Strawn et al., 2015 (101) GAD 10 30–120 53.6 GAD (30–60 mg/day)b 7 SAEs among 5 participants in acute/extension treatment phase, 1 SAE in taper phase
 Duloxetine 135
 Placebo 137
Rynn et al., 2001 (102) GAD 9 50 Fixed dose OCD Among treatment group, more adverse events of dry mouth, drowsiness, leg spasms, restlessness
 Sertraline 11
 Placebo 11
Beidel et al., 2007 (95) SoP 12 ≤40 Average not reported Major depressive disorder (10–20 mg/day),b OCD (20–60 mg/day)b No reported suicidal ideation/parasuicidal behavior
 Fluoxetine 33
 SET 57
 Placebo 32
Wagner et al., 2004 (103) SoP 16 ≤50 24.8 4 in treatment group had suicidal ideation or threatened suicide (1 self-harm in addition); 3 occurred during treatment, 1 during follow up; 1 additional self-harm for attention
 Paroxetine 163
 Placebo 156
March et al., 2007 (104) SoP 16 37.5–225 141.5±47.5 (for >0 days of exposure), 155±39.0 (for >112 days of exposure) 3 cases of suicidal ideation (treatment group), no suicides or attempts
 Venlafaxine ER 137
 Placebo 148
RUPP, 2001 (105) GAD, SoP, SAD 8 300 2.9±1.3 mg/kg OCD (50–200 mg/day)b In treatment group, abdominal discomfort higher, trend toward increased motor activity; 5 cases of study withdrawal due to adverse events: sedation, somatic discomfort, or hyperactivity
RUPP, 2001 (105) (continued)
 Fluvoxamine 61
 Placebo 63
BMS (2010) GAD 8 15–60 Average not reported
 Buspirone
 Placebo
Rynn et al., 2007 (106) GAD 8 37.5–225 Average not reported 4 participants had serious adverse events (2 treatment group, 2 placebo)
 Venlafaxine ER 157
 Placebo 163
a

GAD, generalized anxiety disorder; SAD, separation anxiety disorder; CBT, cognitive-behavioral therapy; OCD, obsessive-compulsive disorder; ER, extended release; SoP, social phobia; OCD, obsessive-compulsive disorder; SET, social effectiveness therapy; SAE, significant adverse events; RUPP, Research Unit on Pediatric Psychopharmacology Anxiety Study Group; BMS, Bristol-Myers Squibb

b

Pediatric dosage range recommended by the Food and Drug Administration (FDA).