A prospective open-label treatment trial of ziprasidone monotherapy in children and adolescents with bipolar disorder.
OBJECTIVE
To assess the effectiveness and tolerability of ziprasidone for treating pediatric mania.


METHODS
This was an eight-week, open-label, prospective study of ziprasidone monotherapy (57.3 +/- 33.9 mg/day) in 21 bipolar youth [manic, mixed, or bipolar not otherwise specified (NOS); 6-17 years old]. Assessments included the Young Mania Rating Scale (YMRS), Clinical Global Impressions-Improvement scale (CGI-I), and Brief Psychiatric Rating Scale (BPRS). Adverse events were assessed through spontaneous self-reports, vital signs, weight monitoring, and laboratory analysis.


RESULTS
Fourteen of the 21 youth (67%) completed the study. Ziprasidone treatment was associated with clinically and statistically significant improvement in mean YMRS scores (-10.8 +/- 8.4, p < 0.0001) and 57% had a CGI-I <or=2 at endpoint. Ziprasidone was well tolerated with no statistically significant increase in body weight (0.6 +/- 0.4 kg, p = 0.2) or QTc interval (-3.7 +/- 4.7, p = 0.5).


CONCLUSIONS
Open-label ziprasidone treatment was associated with a significant short-term improvement of symptoms of pediatric bipolar disorder. Future placebo-controlled, double-blind studies are warranted.
Biederman
Joseph
J
Massachusetts General Hospital, Pediatric Psychopharmacology Research Department, 32 Fruit Street, Yawkey Center for Outpatient Care-Yaw-6A, Boston, MA 02114, USA. jbiederman@partners.org
Mick
Eric
E
Spencer
Thomas
T
Dougherty
Meghan
M
Aleardi
Megan
M
Wozniak
Janet
J
D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy*; D001835:Body Weight / Q000187:drug effects; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D008297:Male; D010372:Pediatrics; D010879:Piperazines / Q000627:therapeutic use*; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D012720:Severity of Illness Index; D013844:Thiazoles / Q000627:therapeutic use*
D014150:Antipsychotic Agents; D010879:Piperazines; D013844:Thiazoles; C092292:ziprasidone