Prospective open-label pilot trial of mirtazapine in children and adolescents with social phobia.
Mirtazapine is indicated for major depression and used for anxiety in adults; however, little is known about its application in pediatric populations. This is an 8-week open-label pilot study of mirtazapine in children with social phobia age 8-17 years. Primary outcomes were symptom improvement based on clinician rating and self-report, as well as tolerability based on rates of discontinuation due to adverse effects. Fifty-six percent (10/18) responded to treatment, 17% (3/18) achieved full remission. Social phobia symptoms improved significantly during the first 2 weeks of treatment, as did comorbid symptoms of depression and anxiety. Eleven patients (61%) did not complete all 8 weeks of treatment; four patients (22%) discontinued due to adverse effects including fatigue and irritability. The others discontinued due to study burden (28%), insufficient response (6%), or to pursue herbal treatment (6%). Significant weight gain was observed. Larger controlled trials are needed to further evaluate efficacy and safety.
Mrakotsky
Christine
C
Department of Psychiatry, Children's Hospital Boston, 300 Longwood Avenue, Fegan 8, Boston, MA 02115, United States.
Masek
Bruce
B
Biederman
Joseph
J
Raches
Darcy
D
Hsin
Olivia
O
Forbes
Peter
P
de Moor
Carl
C
DeMaso
David Ray
DR
Gonzalez-Heydrich
Joseph
J
D000293:Adolescent; D000367:Age Factors; D000929:Antidepressive Agents, Tricyclic / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D004305:Dose-Response Relationship, Drug; D006801:Humans; D008803:Mianserin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D000078785:Mirtazapine; D010698:Phobic Disorders / Q000188:drug therapy*; D010865:Pilot Projects
D000929:Antidepressive Agents, Tricyclic; D008803:Mianserin; D000078785:Mirtazapine