Table 1.
Baseline Demographic and Clinical Characteristics of SMD Youths Randomized to Lithium (n = 14, SMD-Lithium) versus Placebo (n = 11, SMD-Placebo)
| Characteristic | SMD-lithium (n = 14)* | SMD-placebo (n= 11) | Statistics | ||
|---|---|---|---|---|---|
| Age | 10.85 ± 1.99 | 12.18 ± 2.13 | t = ±1.60, df = 23, p = 0.12 | ||
| Full-scale IQ | 108.9 ± 15.7 | 100.0 ± 12.7 | t = 1.47, df = 22, p = 0.16 | ||
| Baseline II | |||||
| YMRS | 14.9 ± 4.0 | 14.3 ± 4.8 | t = 0.28, df = 21, p = 0.78 | ||
| CDRS | 29.9 ± 6.4 | 26.7 ± 5.0 | t = 1.33, df = 22, p = 0.20 | ||
| PANSS factor 4 | 17.6 ± 3.3 | 16.5 ± 2.0 | t = 0.92, df = 22, p = 0.37 | ||
| CGI-Severity | 4.8 ± 0.9 | 4.4 ± 0.7 | t = 1.03, df = 19, p = 0.32 | ||
| CGAS | 43.3 ± 8.4 | 45.3 ± 3.2 | t = ±0.72, df = 22, p = 0.48 | ||
| n | % | n | % | ||
| Sex | |||||
| Male | 13 | 93% | 6 | 55% | χ2 = 4.96, |
| Female | 1 | 7% | 5 | 45% | p = 0.03 |
| DSM-IV-TR diagnoses | |||||
| MDD | 3 | 21% | 2 | 18% | χ2 = 0.03, p = 0.84 |
| ADHD | 14 | 100% | 9 | 82% | χ2 = 2.77, p = 0.10 |
| ODD | 12 | 86% | 10 | 91% | χ2 = 0.16, p = 0.69 |
| CD | 0 | 0% | 0 | 0% | N/A |
| Any anxiety disorder | |||||
| GAD | 2 | 14% | 5 | 45% | χ2 = 2.97, p = 0.09 |
| Separation anxiety disorder | 2 | 14% | 1 | 9% | χ2 = 0.16, p = 0.69 |
| Specific phobia | 4 | 29% | 1 | 9% | χ2 = 1.46, p = 0.23 |
| Social phobia | 1 | 7% | 1 | 9% | χ2 = 0.03, p = 0.86 |
| Panic disorder | 0 | 0% | 0 | 0% | N/A |
| PTSD | 1 | 7% | 0 | 0% | χ2 = 0.82, p = 0.37 |
| Enuresis | 4 | 29% | 1 | 9% | χ2 = 1.22, p = 0.27 |
Lithium group includes 2 subjects who were withdrawn after week 3. FSIQ data not obtained in 1 placebo completer.
Abbreviations: SMD = Severe mood dysregulation; df = degrees of freedom; IQ = intelligence quotient; YMRS = Young Mania Rating Scale; CDRS = Children’s Depression Rating Scale; PANSS-4 = Positive and Negative Symptom Scale for Schizophrenia factor 4; CGI-S = Clinical Global Impressions–Severity; CGAS = Children’s Global Assessment Scale; DSM-IV-TR = Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision; MDD = major depressive disorder; ADHD = attention-deficity/hyperactivity disorder; ODD = oppositional defiant disorder; CD = conduct disorder; GAD = generalized anxiety disorder; N/A = not available; PTSD = posttraumatic stress disorder.