Open-label, 8-week trial of olanzapine and risperidone for the treatment of bipolar disorder in preschool-age children.
BACKGROUND
To evaluate short-term safety and efficacy of atypical antipsychotics in a single-site, prospective, open-label, 8-week study of risperidone and olanzapine monotherapy in preschoolers with bipolar disorder (BPD).


METHODS
Risperidone was initiated at an open-label dose of .25 mg/day, increased weekly according to response and tolerability to a maximum does of 2.0 mg/day. Olanzapine was initiated at 1.25 mg/day and increased to no more than 10 mg/day.


RESULTS
Thirty-one children aged 4-6 years were treated with olanzapine (n = 15, 6.3 +/- 2.3 mg/day) or risperidone (n = 16, 1.4 +/- .5 mg/day). At study end point (week 8 or last observation carried forward), there was a 18.3 +/- 11.9 point (t = -5.6, p < .001) reduction in risperidone-treated subjects and a 12.1 +/- 10.4 point (t = -4.4, p < .001) reduction in Young Mania Rating Scale (YMRS) scores in olanzapine-treated subjects that did not differ between groups (t = 1.4, p = .2). Response criteria (Clinical Global Impression improvement of "Much" or "Very Much" improved or a YMRS change of >or= 30% or more) indicated no difference in rate of response with risperidone and olanzapine (69% vs. 53%, chi(2)((1)) = .8, p = .4).


CONCLUSIONS
This prospective open study suggests that treatment with risperidone or olanzapine may result in a rapid reduction of symptoms of mania in preschool children with BPD. Because of substantial residual symptomatology and adverse effects, however, a pressing need exists to identify additional safe and effective treatments for the management of BPD in this high-risk population.
Biederman
Joseph
J
Pediatric Psychopharmacology Research Department, Massachusetts General Hospital, Boston, Massachusetts 02114, USA. jbiederman@partners.org
Mick
Eric
E
Hammerness
Paul
P
Harpold
Theresa
T
Aleardi
Megan
M
Dougherty
Meghan
M
Wozniak
Janet
J
D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001569:Benzodiazepines / Q000009:adverse effects / Q000627:therapeutic use; D001714:Bipolar Disorder / Q000097:blood / Q000188:drug therapy* / Q000523:psychology; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D008297:Male; D000077152:Olanzapine; D010865:Pilot Projects; D011388:Prolactin / Q000097:blood; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D018967:Risperidone / Q000009:adverse effects / Q000627:therapeutic use*; D012959:Socioeconomic Factors
D014150:Antipsychotic Agents; D001569:Benzodiazepines; D011388:Prolactin; D018967:Risperidone; D000077152:Olanzapine