TABLE 1.
Double-blind Randomized Placebo-controlled Clinical Trials Measuring the Efficacy of Psychostimulants in Treating Emotional Dysregulation in ADHD
| Study (Year) | Participants: (N) | Design (Duration) | Medication (dose)a | Outcome Measure | Treatment Response |
|---|---|---|---|---|---|
| Adults | |||||
| Reimherr et al. (2007) | (47) Adults w/ primary ADHD |
Crossover, placebo- controlled trial (Each arm: 4 weeks) | OROS Methylphenidate (0.75 mg/kg) | Wender- Reimherr Adult ADHD Scale, emotional dysregulation items | OROS Methylphenidate reduced emotional dysregulation (effect size: 0.7) |
| Rösler et al. (2010) | (363) Adults w/ primary ADHD |
Multi-center, parallel group, placebo- controlled trial (24 weeks) | Methylphenidate-ER (0.55 mg/kg) | Wender- Reimherr Adult ADHD Scale, emotional dysregulation items | Methylphenidate – ER reduced emotional lability (effect size: 0.28– 0.4) |
| Marchant et al. (2011) | (90) ADHD alone: N=21; ADHD + EDb: N=28; ADHD + ODDc: N=9; ADHD + ED + ODD: N=32 |
Cross-over, placebo- controlled trial of transdermal MPH (each arm: 4 weeks) | Transdermal Methylphenidate Patch (23.8 mg ± 6.6 mg) | Wender- Reimherr Adult ADHD Scale, emotional dysregulation items | All groups showed benefit on psychostimulants; trend for those with ED to demonstrate greatest improvement |
| Children | |||||
| Childress et al. (2011) | (283) 6–12 years with primary ADHD; 179 with prominent emotional lability at baseline |
Multi-center, parallel group, placebo- controlled trial (4 weeks total) | Lisdexamfetamine (LDX) (30, 50, or 70 mg/day) | Conners Parent Rating Scale of emotional lability (angry, loss of temper, and irritability) | Lisdexamfetamine significantly reduced emotional dysregulation in participants with prominent emotional lability but not in those with low emotional lability |
| Coghill et al. (2007) | (75) 7–15 boys with ADHD (76% with comorbid diagnoses; 41% with ODD & 28% with Conduct Disorder |
Cross-over, placebo- controlled trial (12 weeks total) | Methylphenidate 0.3 vs. 0.6 mg/kg/dose BID vs. placebo | Conners Parent and Teacher Rating Scales of emotional lability | Low and high doses of Methylphenidate significantly reduced emotional lability in parent and teacher reports. Low dose (effect-size parent: 0.46; teacher: 0.45). High dose (effect size parent: 0.42; teacher: 0.79) |
a
Mean Dosage
b
ED: Emotional dysregulation
c
ODD: Oppositional Defiant Disorder