Table 1.
Supporting Evidence in High-Risk Populations (Top) and Pediatric Bipolar Depression (Lower)
| Study | Diagnosis | N | Ages | Design | Length | Medication | 1° Outcome | Results |
|---|---|---|---|---|---|---|---|---|
| High-risk studies (all subjects with positive family history of bipolar disorder) | ||||||||
| Geller et al. (1998) | MDD | 30 | 6–12 | DB, PCB-C | 6 weeks | LIT vs. PCB | CGAS, 9-item K-SADS | No difference between active and PCB groups |
| Chang et al. (2003) | MDD, DYS, CYCL, ADHD | 24 | 6–18 | Open-label | 12 weeks | DVX | CGI-I | 18 of 23 (78%) responders |
| DelBello et al. (2007) | BD NOS, DYS, BD II, CYCL, MDD | 20 | 12–18 | Single-blind | 12 weeks | QUE | CGI-I | 15 of 20 (75%) responders |
| Findling et al. (2007) | BD NOS, CYCL | 56 | 5–17 | DB, PCB-C | 5 years | DVX vs. PCB | Time to study discontinuation | No difference between groups |
| Findling et al. (2008) | MDD | 9 | 7–16 | Open-label, randomized | up to 24 months | PAR vs. DVX | YMRS, CDRS, CGAS, CGI-S, CGI-I | Over 50% of subjects had manic/hypomanic symptoms or suicidality; study discontinued after nine subjects enrolled |
| Pediatric bipolar depression studiesa | ||||||||
| Chang et al. (2006) | BD I, II, NOS | 20 | 12–17 | Open-label | 8 weeks | LTG | CGI-I | 16 of 19 responders (84%) |
| Patel et al. (2006) | BD I | 27 | 12–18 | Open-label | 6 weeks | LIT | CDRS-R, CGI-BP | 13 of 27 (48%) response, 8 of 27 (30%) remission |
| DelBello et al. (2009) | BD I | 32 | 12–18 | DB, PCB-C | 8 weeks | QUE vs. PCB | CDRS-R | No difference between treatment and PCB group |
Olanzapine/fluoxetine was approved for treatment of pediatric bipolar disorder after the study and, therefore, was not included in the algorithm.
ADHD, attention-deficit/hyperactivity disorder; BD NOS, bipolar disorder not otherwise specified; BD I, bipolar I disorder; BD II, bipolar II disorder; CGAS, Children's Global Assessment Scale; CDRS-R, Child Depression Rating Scale, Revised; CYCL, cyclothymia; DYS, dysthymia; MDD, major depressive disorder; DVX, divalproex; FLU, fluoxetine; LIT, lithium; LTG, lamotrigine; OLZ, olanzapine; PAR, paroxetine; PCB, placebo; QUE, quetiapine; WASH-U-KSADS, Washington University Kiddie Schedule for Affective Disorders and Schizophrenia; YMRS, Young Mania Rating Scale.