TABLE 2.
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 |
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
Pediatric dosage range recommended by the Food and Drug Administration (FDA).