Table 16Characteristics of studies examining bipolar disorder

Author, Year, Study Design, Duration, KQIntervention (N Enrolled), Dosage (mg/day) Mean±SDAge, Mean±SD (Range) / Males (%) / White (%) ComorbiditiesDiagnosis Breakdown (n) Quality Rating
SGAs vs. SGAs
Findling et al, 200967
RCT, 4 wk
KQ1, KQ3
G1: Aripiprazole (low) (98), range: 2–10 mg/day
G2: Aripiprazole (high) (99), range: 2–30 mg/day
G3: Placebo (99)
G1: 13.7±2.2 yr / Male: 53% / White: 66%
G2: 13.3±2.3 yr / Male: 52% / White: 69%
G3: 13.3±2.1 yr / Male: 57% / White: 61%
Comorbidities: ADHD (153), DBD (93), psychosis (14)
Bipolar I (all), mania (119), mixed (125), unknown (52)
High ROB
Biederman, 200464
RCT, 8 wk
KQ1, KQ3
G1: Olanzapine (19), 8.5±3.2 mg/day
G2: Quetiapine (19), 213.1±150.5 mg/day
G3: Risperidone (42), 1.36±0.7 mg/day
G4: Ziprasidone (21), 56.2±34.3
All groups: 10.2±2.7 yr / Male: 67% / White: NR
Comorbidities: NR
mania (all)
High ROB
Biederman et al, 200563
RCT, 8 wk
KQ1, KQ3
G1: Olanzapine (15), 6.3±2.3 mg/day
G2: Risperidone (16), 1.4±0.5 mg/day
G1: 5.0±0.8 yr / Male: 67% / White: 100%
G2: 5.3±0.8 yr / Male: 75% / White: 94%
Comorbidities: ADHD (19), CD (13), MDD (22)
Bipolar I (27), bipolar NOS (4), mania (all)
High ROB
NCT00090311, 2008 73
RCT, 3 wk
KQ1, KQ3
G1: Quetiapine, low dose (93), 400 mg/day
G2: Quetiapine, high dose (95), 600 mg/day
G3: Placebo (89)
G1: 13.1±2.2 yr / Male: 51% / White: 79%
G2: 13.2±2.2 yr / Male: 58% / White: 77%
G3: 13.3±2.1 yr / Male: 61% / White: 75%
Comorbidities: ADHD (124)
Manic (272), Mixed (5)
High ROB
Haas et al, 200968
RCT, 3 wk
KQ1, KQ3
G1: Risperidone (low) (50), range: 0.5–2.5 mg/day
G2: Risperidone (high) (61), range: 3–6 mg/day
G3: Placebo (58)
G1: NR / Male: 56% / White: 70%
G2: NR / Male: 43% / White: 82%
G3: NR / Male: 48% / White: 78%
Comorbidities: ADHD (85), DBD (101)
Bipolar I (all), manic episode (60), mixed episode (109)
High ROB
DelBello et al, 200842
RCT, 3 wk (24 wk extension)
KQ1, KQ3
G1: Ziprasidone (low) (15), target: 80 mg/day
G2: Ziprasidone (high) (31), target: 160 mg/day
G1: 13.2±2.1 yr / Male: 47% / White: NR
G2: 13.8±2.4 yr / Male: 77% / White: NR
Comorbidities: NR
Bipolar I (all)
High ROB
SGA vs. Placebo
Tramontina et al, 200972

RCT, 6 wk

KQ1, KQ3
G1: Aripiprazole (18), 13.6±5.4 mg/day
G2: Placebo (25)
G1: 11.7±2.7 yr / Male: 33% / White: 83%
G2: 12.2±2.8 yr / Male: 56% / White: 96%

Comorbidities: ADHD (all), anxiety disorders (21), DBD (35), psychosis (16)
Bipolar I (35), bipolar II (8)

High ROB
Tohen et al, 200771

RCT, 3 wk (6 mo extension)

KQ1, KQ3
G1: Olanzapine (107), 8.9 mg/day
G2: Placebo (54)
G1: 15.1±1.3 yr / Male: 57% / White: 66%
G2: 15.4±1.2 yr / Male: 44% / White: 76%

Comorbidities: ADHD (58), DBD (49)
Bipolar I (all), mixed (86), psychotic features (29), rapid cycling (30)

High ROB
DelBello et al, 200965

RCT, 8 wk

KQ1, KQ3
G1: Quetiapine (17), 403±133 mg/day
G2: Placebo (15)
G1: 16.0±2 yr / Male: 29% / White: 82%
G2: 15±2 yr / Male: 33% / White: 80%

Comorbidities: ADHD (4), anxiety disorder (8), DBD (8), psychosis (3)
Bipolar I with depressive episode (all)

High ROB
DelBello et al, 200266

RCT, 6 wk

KQ1, KQ3
G1: Quetiapine (15), 432 mg/day
G2: Placebo (15)
G1: 14.1±2 yr / Male: 53% / White: 80%
G2: 14.5±2 yr / Male: 53% / White: 87%

Comorbidities: ADHD (18), psychosis (14)
Bipolar I (all), mixed episode (23)

High ROB
NCT00257166, 200870

RCT, 4 wk

KQ1, KQ3
G1: Ziprasidone (149), target: 60–80 mg/day (<45 kg), 120–160 mg/day (>45 kg)
G2: Placebo (88)
G1: 13.6 yr / Male: NR / White: NR
G2: 13.7 yr / Male: NR / White: NR

Comorbidities: NR
Bipolar I (all)

High ROB

ADHD = attention deficit hyperactivity disorder; CD = conduct disorder; DBD = disruptive behavior disorder; G = group; KQ = key question; MDD = major depressive disorder; mg = milligrams; mo = month; N = number; NOS = not otherwise specified; NR = not reported; RCT = randomized controlled trial; ROB = risk of bias; SD = standard deviation; SGA = second-generation antipsychotic; wk = week; yr = year

From: Results

Cover of First- and Second-Generation Antipsychotics for Children and Young Adults
First- and Second-Generation Antipsychotics for Children and Young Adults [Internet].
Comparative Effectiveness Reviews, No. 39.
Seida JC, Schouten JR, Mousavi SS, et al.

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