Table 1.
Review of aripiprazole evidence in children and adolescents
| Level of Evidence* | Report Type | Year/Lead Author/Journal | # of pts (n), % males | Pt age (mean and/or range) (years) | Indication(s) | Aripiprazole Daily Dose | Aripiprazole Monotherapy ? | Duration of treatment | Efficacy Rating Scales (Bold = 1ϒ Endpoint) | Efficacy Results | Adverse Effects | Metabolic effects |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1b |
Prospective Randomized Controlled Trial |
2009;
Corey-Lisle P; Kamen L; APA poster presentations NR2-061, NR2-063 (flexible-dose trial) |
n=98 (88% male) | Pl: 8.8 ± 2.6
A: 9.7 ± 3.2 |
Autistic Disorders | Flexible Dose (range: 2-15 mg)
vs placebo |
Yes (implied) | 8 weeks | ABC-I, CGSQ, PedsQL |
ABC-I: (treatment difference vs Pl, − score denotes improvement) −7.9 CGSQ: (treatment difference vs Pl, − score denotes improvement) −1.9 ± 0.8 PedsQL: (treatment difference vs Pl, + score denotes improvement) +11.4 ± 5.6 |
Pooled reporting of flexible and fixed-dose trials (% above Pl):
Sedation (17%), fatigue (15%), EPS (11%), tremor (10%), drooling (10%), vomiting (8%), increased appetite (7%), fever (7%), somnolence (6%), decreased appetite (5%), increased salivation (5%) |
Pooled reporting of flexible and fixed-dose trials:
Mean weight change: Pl: 0.4 kg; A: 1.6 kg Mean BMI change: Pl: 0.2; A: 0.7 Mean BMI z-score change: Pl: 0.01; A: 0.11 |
| 2008a;
Owen R; AACAP poster presentation 3.59 | ||||||||||||
| Negligible changes in glucose, lipids | ||||||||||||
| 1b |
Prospective Randomized Controlled Trial |
2009;
Corey-Lisle P; Kamen L; APA poster presentations NR2-061, NR2-063 (fixed-dose trial) |
n=218 (89% male) | Pl: 10.2 ± 3.1
A5: 9 ± 2.8 A10: 10 ± 3.2 A15: 9.5 ± 3.1 |
Autistic Disorders | 5, 10 or 15 mg
vs placebo (1:1:1:1 randomization) |
Yes (implied) | 8 weeks | ABC-I, CGSQ, PedsQL |
ABC-I: (treatment difference vs Pl, − score denotes improvement) A5: −4.5; A10: −5.8; A15: −6.5 CGSQ: (treatment difference vs Pl, − score denotes improvement) A5: −0.4 ± 0.8; A10: −0.2 ± 0.75; A15: −1.1 ± 0.8 PedsQL: (treatment difference vs Pl, + score denotes improvement) A5: 3.4 ± 6.6; A10: −0.2 ± 6.7; A15: 8.2 ± 6.8 |
Pooled reporting of flexible and fixed-dose trials (% above Pl):
Sedation (17%), fatigue (15%), EPS (11%), tremor (10%), drooling (10%), vomiting (8%), increased appetite (7%), fever (7%), somnolence (6%), decreased appetite (5%), increased salivation (5%) |
Pooled reporting of flexible and fixed-dose trials:
Mean weight change: Pl: 0.4 kg; A: 1.6 kg Mean BMI change: Pl: 0.2; A: 0.7 Mean BMI z-score change: Pl: 0.01; A: 0.11 |
| 2008b;
Owen R; AACAP poster presentation 3.60 |
Negligible changes in glucose, lipids | |||||||||||
| 1b |
Prospective Randomized Controlled Trial |
2008;
Werner C; CINP poster presentation |
N=296 (54% males) | 13.43 (range: 10–17) | Bipolar Disorder - type I | 10 or 30 mg vs placebo (1:1:1 ratio) | Yes (implied) | 4 weeks plus 26 week double-blind continuation | ARS-IV, CDRS-R, CGAS, CGI BP, GBI, YMRS | (shown as change from basline)
ARS-IV: Pl: −4.6; A10: −11.6; A30: −10.1 CGAS: Pl: −7; A10: −16; A30: −17 CGI-BP: Pl: −0.8; A10: −1.6; A30: −1.8 GBI (mania): Pl: −4.3; A10: −9; A30: −8.9 YMRS: Pl: −8.2; A10: −14.1; A30: −14.9 (p<0.001 for A10 and A30 vs placebo) Responders (≥ 50% reduction in YMRS): Pl: 27%; A10: 50%; A30: 56% |
relative to placebo:
A10: somnolence (24.5%), fatigue (18.4%), EPS (12.2%), blurred vision (10%), nausea (8%), akathisia (7%), increased appetite (5%), suicidal ideation (1%) |
Mean change in weight z-score:
Pl: 0; A10: 0.13; A30: 0.19 (z-score changes of < 0.5 considered not clinically significant) No significant changes in cholesterol, triglycerides, glucose Prolactin: Pl: −0.4 mcg/mL; A10: −4 mcg/mL; A30: −2.3 mcg/mL |
| A30: EPS (28.3%), somnolence (27.3%), fatigue (12.1%), akathisia (11%), nausea (8%), blurred vision (8%), increased appetite (5%), suicidal ideation (1%) | ||||||||||||
| 1b |
Prospective Randomized Controlled Trial (1b) |
2008a;
Findling RL; Am J Psychiatry |
n=302 (57% males) | 15.5 ± 1.3 (range: 13–17) | Schizophrenia | 10 or 30 mg vs
placebo (1:1:1 ratio) |
Yes (adjunctive benzodiazepines or benztropine permitted) | 6 weeks | CGAS, CGI-I, CGI-S, PANSS, PQLESQ | CGAS week 6 change: Pl: +9.8 ± 1.3;
A10: +14.7 ± 1.5; A30: + 14.8 ± 1.3; CGI-I week 6 scores: Pl: 3.1 ± 0.1; A10: 2.7 ± 0.1; A30: 2.5 ± 0.1 CGI-S week 6 changes: Pl: −0.9 ± 0.1; A10: −1.2 ± 0.1; A30: −1.3 ± 0.1 PANSS week 6 change: Pl: −21.2 ± 1.9; A10: −26.7 ± 1.9; (p=0.05 vs placebo) A30: −28.6 ± 0.9 (p=0.007 vs placebo) PQLESQ week 6 change: Pl: 4.5 ± 0.9; A10: 5.2 ± 0.9; A30: 5.9 ± 0.9 |
Side effects occurring at ≥ 5% incidence (relative to placebo) | Mean weight changes:
Pl: −0.8 ± 2.6 kg; A10mg: 0 ± 2.1 kg; A30mg: 0.2 ± 2.3 kg |
| A10: EPS (8%), headache (6%), somnolence (5%) | pts with weight gain ≥ 5%:
Pl: 2%; A10: 11%; A30: 9% |
|||||||||||
| A30: EPS (17%), somnolence (16%), tremor (10%), akathisia (7%) | No significant change in glucose, prolactin, cholesterol or triglyceride levels in either treatment group compared to placebo | |||||||||||
| 2b | Prospective Open label trial | 2009;
Bastiaens L; Community Mental Health J |
n=46 (78% males) | 11.9 ± 2.6 (range 6–17) | Aggression (largest group: Conduct
Disorder: 30%) |
Assigned to A or Z in non-randomized fashion
A:4.5 ± 2.3 mg Z: 42.9 ± 18 mg |
No (30% on stimulants; 22% on atomoxetine) | 2 months | CGI-I, GAF, HALFS, OAS, pYMRS |
OAS: 70% of A completers (58% by ITT) had ≥ 50% decrease in OAS (A mean change 6.8 ± 1.8 to 2.3 ± 2.9); 71% of Z completers (45% by ITT) had ≥ 50% decrease in OAS (Z mean change 7.4 ± 2.1 to 3.1 ± 2); CGI-I: mean rating at endpoint: A: 2 ± 1.2; Z: 2.3 ± 1.4; GAF: A: 50 ± 4.7 to 61 ± 7.7; Z: 46.4 ± 2.4 to 57.9 ± 7.6 HALFS: A: 9.7 ± 4 to 13.1 ± 4; Z: 8.1 ± 4.7 to 11.6 ± 3.6 pYMRS: A: 24.7 ± 9.3 to 9.8 ± 8.2; Z: 23.3 ± 7 to 8.7 ± 7 (all figures shown are for study completers only) |
Sedation (50% of completers), dizziness, EPS, headaches, nausea (each in 10% of completers)
4/24 pts discontinued study (17%) − 2 of these 4 due to sedation |
Not reported |
| 2b | Prospective Open label trial | 2009;
Stigler K; JCAP |
n=25 (76% males) | 8.6 (range: 5–17) | PDD-NOS, Asperger's Disorder | 7.8 mg (range: 2.5–15 mg) | Yes | 14 weeks | ABC, CGI-I, CY-BOCS-PDD, VABS |
ABC: 29 ± 7.3 to 8.1 ± 7.5 CGI-I: 88% rated as much improved or very much improved (CGI-I ≤ 2) and with ≥ 25% improvement on ABC CY-BOCS-PDD: 11.9 ± 2 to 6.8 ± 4.1 VABS: improvement on socialization domain noted |
tiredness (56%), cough (48%), increased appetite (44%), nausea/vomiting (40%), rhinitis (40%), constipation (36%), dry mouth (32%), dyspepsia (32%), sialorrhea (16%), tremor (12%) | Mean weight change: 2.7 kg (range: −3.3 to 8.1 kg).
76% of pts gained weight (not adjusted for growth) |
| Mean BMI change: 20.3 ± 6.1 to 21.1 ± 5.7 | ||||||||||||
| Prolactin levels decreased significantly, no significant change in blood glucose or lipids noted | ||||||||||||
| 2b | Prospective Open label trial | 2008;
Seo W; JCAP |
n=15 (93% males) | 12.2 ± 3.7 (range: 7–19) | Tourette Disorder or Chronic Tic Disorder | 8.17 ± 4.06 mg (range: 2.5–15 mg) | Monotherapy in 60% | 12 weeks | YGTSS |
YGTSS: 24.53 ±11.12 to 10.87 ± 7.54 Changes noted starting at week 3 and continuing to study endpoint |
sedation (47%), nausea (33%) | Mean BMI change: 0.08 ± 0.63 |
| 2b | Prospective Open label trial (2b) | 2008c;
Findling R; J Clin Psychopharmacol |
n=21 (67% male) | 12.2 ± 2.1 (Range: 10–17) | Bipolar Disorder, Tourette
Syndrome, schizophrenia, ADHD, OCD, PDD |
Titrated to 20, 25 or 30 mg day (1:1:1 ratio) | Yes (67% on various concomitant non-psychotropic medications) | 2 weeks (at target dose) | CGI-I, CGI-S |
CGI-I: 85% of all pts much improved or very much improved (CGI-I ≤ 2) CGI-S: A20: 4 to 2.4; A25: 3.7 to 2.3; A30: 3.5 to 1.2 |
headache (29%), abdominal pain (24%), dizziness (19%), vomiting (14%), fatigue (10%), stiffness (10%), dystonia (10%), sedation (10%), somnolence (10%) | Mean weight changes:
A20: −0.2 ± 2.5 kg; A25: 0.9 ± 2.3 kg; A30: 0.4 ± 1.8 kg |
| No clinically relevant changes in glucose, prolactin, cholesterol or triglycerides | ||||||||||||
| 2b | Prospective Open label trial | 2008b;
Findling R; JCAP |
n=23 (61% males) | 10.2 ± 1.4 (range: 8–12) | ADHD (Combined subtype or Inattentive subtype) | 6.7 ± 2.4 mg | Yes (35% pre-treated with stimulants were stopped on enrollment) | 6 weeks | ARS-IV, CGAS, CGI-I, CGI-S |
ARS-IV: 36.8 ± 11.5 to 21.5 ± 11.1 CGAS: 62.8 ± 4.6 to 71 ± 8.6 CGI-I: 61% much improved or very much improved (CGI-I ≤ 2) CGI-S: 4 ± 0.3 to 3.2 ± 0.7 |
sedation (78%), headache (47%), nausea (30%), increased appetite (26%), musculoskeletal pain (26%), EPS (22%), stomach ache (22%), hiccups (17%), flu-like symptoms (17%), vomiting (13%), sore throat (13%) | Mean weight changes:
no prior stimulant Rx: + 1.7 kg prior stimulant Rx:+ 3.7 kg 9% discontinued due to weight gain Glucose: 4.5 ± 0.5 to 4.73 ± 0.46 mmol/L (NS) Prolactin: 4.45 ± 1.45 to 2.88 ± 2.61 (p<0.05) |
| 2b | Prospective Open label trial | 2007;
Yoo H; J Clin Psychiatry |
n=24 (79% male) | 11.8 ± 3.8 | Tic Disorders | 9.8 ± 4.8 mg | 8 weeks | CGI-I, CGI-S, YGTSS | CGI-I: 88% rated as much improved or very much improved (CGI-I ≤ 2) at endpoint
CGI-S: 5.5 ± 0.5 to 3 ± 1.4 YGTSS: 26.7 ± 5.5 to 12.6 ± 7.6 |
parkinsonism (46%), hypersomnia (38%), nausea (21%), headache (17%), EPS, akathisia, decreased volition (8% each) | Not reported | |
| 2b | Prospective Open label trial | 2007;
Woods S; Br J Psychiatry |
n=15 (53% male) | 17.1 ± 5.5 | Prodromal Schizophrenia | 15.7 ± 5.9 mg | Yes (benzodiazepines and anticholinergics permitted) | 8 weeks | BAI, CDSS, GAF, HCRF, SFS, SOPS, YMRS | (scores shown as change from baseline)
BAI: −13.1 ± 11.2 CDSS: −3.8 ± 4.2 GAF: +9.2 ± 5.3 HCRF: +3.2 ± 5.1 SFS: −2 ± 21 SOPS: −29.1 ± 12.3 (p<0.001) YMRS: −3.9 ± 3.6 |
akathisia (53%), irritability (33%), increased appetite (27%), sedation (20%), insomnia, nervousness, memory impaired, sensory perception impaired, increased salivation, decreased libido, excessive sweating (13% each) | Mean weight change: +1.2 ± 2 kg (not adjusted for growth) |
| 2b | Prospective Open label trial | 2007;
Tramontina S; CNS Spectr |
n=10 (50% male) | 9 ± 3.5 (range: 8–17) | Juvenille Bipolar Disorder with comorbid ADHD | 11.7 ± 5.7 mg | No | 6 weeks | CGI-S, SNAP-IV, YMRS |
CGI-S: 4 ± 1.15 to 3 ± 1.63 SNAP-IV: 1.83 ± 0.76 to 1.47 ± 0.75 YMRS: 35.5 ± 11.85 to 20.6 ± 11.68 70% of pts had ≥ 30% reduction in YMRS score, including 2 pts achieving remission. |
sialorrhea (70%), sedation/tiredness (70%), confusion (60%), depressive symptoms (60%), increased appetite (50%), decreased appetite (50%), sweating (50%), tremor (50%), nervousness/anxiety (50%), suicidal ideation (20%) | Actual values not reported, but “a small but significant increase in weight was observed during the trial.” All patients had been off other medications for > 10 weeks prior to enrollment. |
| 2b | Prospective Open label trial (2b) | 2007;
Biederman J; CNS Spectr |
n=19 (58% males) | 11.6 ± 3.6 (range: 6–17) | Bipolar Disorder (I and II) | 9.4 ± 4.2 mg | Monotherapy in 89% (11% receivingstimulants) | 8 weeks | BPRS, CDRS, CGI-I, YMRS |
YMRS: 79% had ≥ 50% reduction mean: 27.3 ± 4.9 to 9.4 ± 4.2; BPRS: 38.9 ± 7.6 to 28.8 ± 9.9; CDRS: 38.6 ± 11.2 to 32.6 ± 17.4; CGI-I: 95% much improved or very much improved (CGI-I ≤ 2) |
Sedation (57%), GI upset (42%), respiratory tract infection (32%), headache (32%), akathisia (15%), sleep problems (15%), depression, slurred speech, pain, anxiety, tremor, EPS (each 11%) | No significant changes in weight, prolactin or metabolic parameters at 8 weeks; mean weight change: +1.8 kg ± 0.6 kg |
| 2b | Prospective Open label trial | 2006;
Yoo H; JCAP |
n=14 (86% male) | 11.93 ± 3.41 (range: 7–17) | Tourette Disorder | 10.89 mg (range: 2.5–15 mg) | Yes | 8 weeks | YGTSS | YGTSS: 27.64 ± 5.96 to 16.57 ± 5.23 | Nausea/vomiting (14%), hypersomnia (7%), weight gain (7%) | Not systematically assessed. One pt reported weight gain of 3 kg |
| 2b | Prospective Open label trial | 2004;
Stigler K; JCAP |
n=5 (100% male) | 12.2 ± 5.07 (range: 5–18) | PDD-NOS | 12 ± 2.74 mg (range: 10–15 mg) | Monotherapy in 40% | mean 12 weeks (range: 8–16 weeks) | CGI-I | CGI-I: 100% rated as much improved or very much improved (CGI-I ≤2) | somnolence (40%), dizziness (20%) | Mean weight change: −3.7 kg (range: −13.6 to 0.45 kg). Some pts previously treated with other second generation antipsychotics |
| 2b | Prospective Open label trial | 2004;
Findling R; CINP poster presentation |
n=23 (% males not reported) | range: 6–17 | Conduct Disorder | Based on weight (range: 1–10 mg, amended from 2–15 mg after significant adverse effects following enrollment of first 4 pts) | Yes (implied) | 2 weeks | CGI-I | CGI-I: 64% of children (≤ 12) and 45% of adolescents (≥ 13) rated as much improved or very much improved (CGI-I ≤ 2) | vomiting (26%), somnolence (26%), dyspepsia (23%), lightheadedness (13%), pharyngitis (9%) | Not reported |
| 4 | Naturalistic
Retrospective Evaluation |
2008;
Budman C; JCAP |
n=37 (70% males) | 13.4 ± 2.8 (range: 8–18) | Tourette Disorder (84% also met criterion for ADHD and OCD, 78% met critieria for IED) | 11.7 ± 7.2 mg (range: 2.5–40 mg) | Monotherapy in 24% | 6–12 weeks | CGI-Rage, CGI-Tics |
CGI-Rage: (in completers) 4.96 ± 1.22 to 2.53 ± 1.13; CGI-Tics: (in completers) 4.38 ± 0.81 to 2.69 ± 0.88 |
akathisia (16%), agitation (8%), mood lability (8%), EPS (3%), extreme sedation (3%), headache, dizziness, nausea, sedation also noted (not quantified); 8/37 pts discontinued study (22%) | Weight data available in only 15 of 37 pts; 13/15 (87%) gained weight; mean change in weight gainers: 8.2 ± 5.6 kg |
| 4 | Naturalistic
Retrospective Evaluation |
2007;
Gibson A; Int Clin Psychopharmacol |
n=45 (29% males) | 15.1 ± 1.5 (range: 11-18) | Any Axis I diagnosis (Most common: Bipolar Disorder (40%), PTSD (31%), substance abuse (22%), depressive disorder, ODD/conduct disorder (20% each) | 16.9 ± 7.9 mg | No | 31.3 ± 19.6 days | CGI-I, CGI-S |
CGI-I: 51% rated as much improved or very much improved (CGI-I ≤ 2) CGI-S: 5.04 ± 0.95 to 3.33 ± 1.24) |
gastrointestinal distress (18%), nausea/vomiting 18%), sedation (11%), akathisia (9%), headache (7%), EPS (4%) | Mean weight change (22/45 pts):
83.22 ± 22.68 kg to 82.77 ± 21.23 kg Mean BMI change (22/45 pts): 30.4 ± 5.17 to 29.98 ± 4.87 |
| 4 | Naturalistic
Retrospective Evaluation |
2004;
Barzman DH; JCAP |
n=30 (60% males) | 13 ± 3 (range: 5–19) | Bipolar
disorder/schizoaffective disorder (bipolar type) |
9 ± 4 mg (range: 5–15 mg) | Monotherapy in 30% | 4.4 ± 2.7 months (range: 1–9 months) | CGI-I, CGI-S, CGAS |
CGI-I: 67% much improved or very much improved (CGI-I ≤ 2) at endpoint; CGAS: significant improvement (mean: 48 ± 11 to 65 ± 11); CGI-S: significant improvement (mean 4.2 ± 0.8 to 2.8 ± 1) |
Sedation (33%), akathisia (23%), GI
upset (7%), blurry vision, speech disturbance, dystonia, tremor (each 3%) |
Weight data available in only 14 of 30 pts;
Mean weight change: −3 ± 6 kg (range: −21 to +5 kg); 12/14 pts (86%) lost weight; (7 of 12 who lost weight were previously treated with another antipsychotic) |
| 4 | Case Series | 2008;
Bachmann CJ; Ther Drug Monit |
n=33 (55% males) | 18.7 ± 1.7 (range 13.5–21.6) | Schizophrenia Spectrum
Disorders |
12.9 mg ± 6.4 mg (range 5–30 mg) | No | range 14–489 days (naturalistic study) | None | Not reported (pharmacokinetic study) | Not reported | Not reported |
| 4 | Case Series | 2007;
Miranda M; Rev Med Chile |
n=10 (% males not specified) | (range: 10–35) | Tourette Syndrome (refractory) | mean: 10 mg (range:7.5–25 mg) | No | 1 month | YGTSS, CGI-S | 90% of patients showed significant response on
YGTSS and CGI-S measurements. |
Not reported | Not reported |
| 4 | Case Series | 2006;
Valicenti-McDermott M; JCAP |
n=32 (72% male) | 10.9 ± 4.3 (Range: 5–19) | Developmental Disability with various comorbid conditions (Mental Retardation, Autism Spectrum Disorders, ADHD, Mood Disorders most frequent) | 10.55 ± 6.9 mg | Monotherapy in 75% | 6.1 ± 4.5 months (range: 0.25–15 months) | Not well defined - Clinical global impression of improvement in target symptoms | Improvement in target symptoms found in 56% | drowsiness (19%), weight gain (13%), increased aggression (7%), stiffness, myalgias, facial dyskinesia, diarrhea (3% each) | Mean BMI change:
23.3 ± 7.2 to 24.1 ± 7 mean BMI z-score change: 1.4 to 1.62 BMI z-score increase more notable in younger children |
| 4 | Case Series | 2006;
Duane D; J Child Neurol |
n=15 (80% males) | 15 (range: 9–25) | Tourette Syndrome | range: 2.5–15 mg | Not specified | 8 weeks | None specified | Excellent tic control in 14/15 (93%) with variable benefits to attention behaviorally and cognitively | nausea (27%), akathisia (27%) | weight gain ≥ 5% in 4/15 (27%); weight loss of ≥
5% in 1/15 (7%) - this pt was previously treated with olanzapine |
| 4 | Case Series | 2006;
Davies L; Human Psychopharmacol Clin Exp |
n=11 (64% males) | 26.7 ± 15.5 (range: 7–50) | Tourette Syndrome | 14.5 ± 3.5 mg (range: 10–20 mg) | Monotherapy in 36% | 1–10 months | MOVES | 5/11 very much improved, 4/11 much improved | Sedation, 2/11 pts with chest pain (aged 7 and 50 respectively - no abnormalities found on cardiovascular workup) | Not reported |
| 4 | Case Series | 2005;
Rugino T; J Child Neurol |
n=17 (88% males) | 11.4 ± 3.9 (range: 5.1–17.9) | Bipolar Disorder, Autism, Psychosis NOS | 12.8 ± 4.5 mg (range: 5–20 mg) | No | 106.6 ± 75.5 days (range: 14–210 days) | CGI-I, CGI-S | CGI-S: 5.8 ± 0.9 at baseline 6/17 pts considered “repsonders” (much improved or very much improved (CGI-I ≤ 2) | Aggression (35%), nausea/vomiting (12%), staring episodes, listlessness, sedation, coarse tremor (6% each). | Mean weight gain (14/17 pts):
3.9 ± 1.6 kg Mean BMI change (14/17 pts): 1.7 ± 0.7 Weight gain appeared to be more with longer duration or higher doses. 9/14 gained more weight than expected for 90% of age/gender matched peers. |
| 4 | Case Series | 2005;
Murphy TK; Int J Neuropsychopharmacol |
n=6 (50% male) | 12.1 ± 4.05 (range: 8–19) | Tourette Syndrome, OCD | 11.7 mg (range: 5–20 mg) | No | 12 weeks | CY-BOCS, YGTSS |
CY-BOCS: 28.2 ± 4.1 to 8.2 ± 5.5 YGTSS: 31.2 ± 8.3 to 13.7 ± 4.4 |
somnolence, dry mouth, teeth chattering, hand tremor (1 report each) | Mean weight gain: 1.9 ± 1.1 kg (range: −5 to 3 kg)
5/6 pts gained weight during trial. Subject who lost weight was actively dieting at the time. BMI increased in 2/6 pts during trial. |
| 4 | Case Series | 2004;
Durkin J; JCAP |
n=24 (92% males) | 12 (range: 5–17) | Bipolar Disorder | 13.75 mg (range: 5–20 mg) | Monotherapy in 4% | Unclear - benefits noted by day 8 of treatment in responders | Patient subjective self-rating (poor, good or excellent) | 59% rated response as good or excellent | sedation (8%), irritability (8%), insomnia (4%), tremor (4%), fainting (4%), agitation (4%), aggression (4%), anxiety (4%), weakness (4%), psychomotor retardation (4%), facial movements (4%), stammering (4%) | Not reported |
| 4 | Case Report | 2008;
Storch E; Depression Anxiety |
n=1 (male) | 13 | OCD | up to 5 mg | No (also receiving sertraline) | ~1 year | CY-BOCS | CY-BOCS: 30 to 3 | None | No clinically significant change in weight or laboratory values reported |
| 4 | Case Report | 2008;
Haffejee S; Dev Med Child Neurol |
n=1 (female) | 14 | Alternating Hemiplegia of Childhood | 1.25 mg | No | 1 year | None | Significant reduction of frequency, duration, severity of episodes of hemiplegia, reduced behavioural outbursts | Not reported | Not reported |
| 4 | Case Report | 2008;
Dhamija R; Diabetes Care |
n=1 (male) | 12 | Mood Disorder NOS | not specified | Yes | 6 months | None | Not reported | Diabetic Ketoacidosis (weight gain, hyperglycemia, polyuria, polydipsia) - resolved with insulin therapy and rehydration | weight gain, hyperglycemia, polyuria, polydipsia |
| 4 | Case Report | 2008;
Groff K; JCAP |
n=1 (male) | 17 | Psychosis NOS | 15 mg | Yes | 10 days | None | Reduced auditory hallucinations at 1 week | Developed catatonic symptoms (echopraxia, waxy flexibility, confusion, disorientation) without rigidity, elevated temperature or elevated CPK - Resolved after 48 hours of lorazepam treatment | Not reported |
| 4 | Case Report | 2007;
Bachmann CJ; J Clin Psychophamacol |
n=1 (Male) | 17 | Schizophrenia | 10 mg | No (also receiving clozapine) | 40 days | None | Not reported | CPK=4572 IU/L
Normalized within 8 days with continued therapy |
None reported |
| 4 | Case Report | 2007;
Strawn JR; JCAP |
n=1 (female) | 15 | PDD-NOS, psychosis,
catatonia |
15 mg/day | No | ≥ 5 days | None | Response noted 8hr following initial dose, and catatonic symptoms resolved after 5 days of aripiprazole therapy | Not reported | Not reported |
| 4 | Case Report | 2007;
Singh M; JAACAP |
n=1 (male) | 10 | Bipolar Disorder | 10 mg | No | 3 days | None | Not reported | Neck pain, stiffness, unusual sensations in jaw. Resolved within 30 minutes following benztropine administration | Not reported |
| 4 | Case Report | 2007;
Palakurthi H; Clin Neuropharmacol |
n=1 (male) | 12 | PDD-NOS | 10 mg | No | 2 days | None | None | Tremor, acute confusional state, muscle rigidity, fever, fluctuating consciousness, increased WBC, respiratory distress, CPK 401 U/L. Resolved after 6 days following treatment in ICU with dantrolene and bromocriptine. | Not reported |
| 4 | Case Report | 2007;
Logue D; Am J Psychiatry |
n=1 (male) | 7 | ADHD (Combined subtype), Aggression | 2.5 mg | Yes | 4 weeks | None | Not reported | Hyperglycemia (36.25 mmol/L), ketonuria, polydipsia, polyphagia, polyuria, hyponatremia (Na=127), HbA1c=10%. Blood glucose normalized after stopping aripiprazole and 4 weeks of insulin therapy | Patient had positive family history of type 2 diabetes. Seven months after initial presentation, the patient developed insulin-dependent diabetes [sic]. |
| 4 | Case Report | 2007;
Curtis AR; Ann Clin Psychiatry |
n=1 (female) | 18 | OCD, psychogenic excoriation | 5 mg | No (fluoxetine 80 mg) | 4 weeks | None | Complete resolution of psychogenic excoriation and 30–40% subjective decrease in OCD symptoms | Not reported | Not reported |
| 4 | Case Report | 2006;
Hammerman S; JAACAP |
n=1 (female) | 14 | Depression with Psychotic Features | 5 mg | Yes | 2 days | None | Not reported | tremors, drooling, cogwheel rigidity, unsteady gait, incontinence, agitation.
CPK 23,340 IU. (afebrile, WBC 9.3). Resolved with lorazepam 2mg po q4h plus sodium bicarbonate treatment. |
Not reported |
| 4 | Case Report | 2006;
Fountoulakis K; Ann Pharmacother |
n=1 (male) | 18 | Tourette Disorder | 10 mg | Yes | 3 days | None | Improvement reported on Day 2 | Dystonia, facial muscle spasm, oculogyric crisis, torticollis on day 3.
Symptoms resolved after 5 mg biperiden IM injection. |
Not reported |
| 4 | Case Report | 2005;
Wahl R; Am J Psychiatry |
n=1 (female) | 17 | Schizophrenia | 15 mg | No (continued on risperidone long-acting injection) | 12 days | None | Symptomatic prolactinemia (breast pain, swelling and galactorrhea), resolved during continued risperidone therapy following addition of aripiprazole. | None reported | serum prolactin = 119 mcg/mL during symptomatic phase. Repeat prolactin following aripiprazole addition = 18 mcg/mL |
| 4 | Case Report | 2005;
Negin B; JAACAP |
n=1 (male) | 16 | Bipolar Disorder NOS, PDD-NOS | 5 mg | No | Approximately 1 month. Pt also receiving lithium and oxcarbazepine | None | Not reported | 2 episodes of priapism. Spontaneously resolved. Oxcarbazepine discontinued, aripiprazole and lithium discontinued and priapism did not recur. | Not reported |
| 4 | Case Report | 2005;
Kantafaris V; JAACAP |
n=1 (male) | 17 | Bipolar Disorder (Type I) | 12.5 mg | No | 6 months (then tapered off over 2 week period) | None | Not reported | Abnormal movements of jaw, tongue and hands, facial twitches - Diagnosed as withdrawal dyskinesias. Resolved after 3 weeks, following treatment with branched chain amino acids. | Not reported |
| 4 | Case Report | 2004;
Myers W; JAACAP |
n=1 (female) | 17 | Delusional Disorder, Erotomanic type | 10 mg | Yes | 5 months | None | Lessening of delusional beliefs beginning at week 2 and maximal at week 8. | None | Not reported |
*
Level of Evidence - as per Centre for Evidence Based Medicine document (2009)
Abbreviations
A=aripiprazole BMI=Body Mass Index CPK=Creatine Phosphokinase EPS=extrapyramidal symtpoms HbA1c=glycosylated Hemoglobin A1c ITT = intention-to-treat analysis Na=sodium NOS=not otherwise specified Pl=placebo pt(s)=patient(s) WBC=White Blood Cells Z=ziprasidone
Abbreviations of Rating Scales used
- ABC-I
- Aberrant Behavior Checklist Irritability subscale
- ARS-IV
- ADHD Rating Scale-IV
- BAI
- Beck Anxiety Inventory
- BPRS
- Brief Psychiatric Rating Scale
- CDRS(-R)
- Children's Depression Rating Scale (- Revised)
- CDSS
- Calgary Depression Scale for Schizophrenia
- CGAS
- Children's Global Assessment Scale
- CGI-I
- Clinical Global Impresssion - Improvement
- CGI-Rage
- Clinical Global Impression - Rage
- CGI-Tics
- Clincal Global Impression - Tics
- CGI-S
- Clinical Global Impression - Severity
- CGSQ
- Caregiver Strain Questionnaire
- CY-BOCS
- Children's Yale-Brown Obsessive Compulsive Scale
- CY-BOCS-PDD
- Children's Yale-Brown Obsessive Compulsive Scale (modified for PDD)
- GAF
- Global Assessment of Functioning
- GBI
- General Behavior Inventory
- HALFS
- Health and Life Functioning Scale
- HCRF
- Heinrichs-Carpenter Quality of Life role functioning subscale
- MOVES
- Motor and Vocal tic Evaluation Scale
- OAS
- Overt Aggression Scale
- PANSS
- Positive and Negative Symptom Scale
- PedsQL
- Pediatric Quality of Life Inventory
- PQLESQ
- Patient Quality of Life Enjoyment and Satisfaction Questionnaire
- pYMRS
- Parent's Young Mania Rating Scale
- SFS
- Social Functioning Scale
- SNAP-IV
- Swanson, Nolan & Pelham ADHD rating scale-IV
- SOPS
- Scale of Prodromal Symptoms
- VABS
- Vineland Adaptive Behavior Scales
- YGTSS
- Yale Global Tic Severity Scale
- YMRS
- Young Mania Rating Scale