Table 1. Studies of Patients With Rapid-Cycling Bipolar Disorder and Recent Substance Use Disorder.
| Study Information | Study 1 (N- 149)a | Study 2 (N = 96)b |
|---|---|---|
| Study design | Open-label stabilization with lithium + divalproex for up to 24 wk: protocol-defined responders receiving lithium + divalproex or lithium + placebo for 24 wk; a placebo-controlled discontinuation maintenance study | Open-label treatment with lithium + divalproex for up to 24 wk; protocol-defined nonresponders receiving lithium + divalproex + placebo or lithium + divalproex + lamotrigine for 6 wk; a placebo- controlled acute depression efficacy study |
| Mood state | Manic/hypomanic/mixed within 3 mo; any mood at screening/baseline | Major depressive episode at screening/baseline |
| Inclusion criteria | Bipolar I or II disorder, rapid cycling within last 12 mo, ≥ 16 y old; no contraindication to lithium or divalproex; substance abuse/dependence within last 6 mo | Bipolar I or II disorder, rapid cycling within last 12 mo. ≥ 16 y old; no contraindication to lithium, divalproex, or lamotrigine; substance abuse within 3 mo. dependence within 6 mo |
| Exclusion criteria | Contraindications to lithium levels of 0.8 mEq/L or divalproex levels of 50 μg/mL | Contraindications to lithium, divalproex, or lamotrigine |
| Data collection | November 1997 to September 2006; study was completed | July 2002 to February 2007; study was ongoing |
a
ClinicalTrials.gov identifier NCl00194I29.
b
ClinicalTrials.gov identifier NCT00221975.