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Awarded Trial: 02T-210
Secondary Drug Intervention
Duration of Study Period for Each Subject
6 weeks + 4 months open-label extension (optional)
IDS-C, CGI-BP, YMRS-C
Subjects with bipolar depression that was inadequately responsive to mood stabilizer +/- additional antidepressant therapy were randomized to adjunctive modafinil (MOD) vs. placebo (PLC) for 6 weeks. The primary outcome measure was baseline to endpoint change in the clinical rated Inventory for Depressive Symptoms (IDS). There was a significantly greater baseline to endpoint IDS change on modafinil (n=41, mean dose 177 mg/d) vs. placebo (n-44). Improvement in depression was significantly greater in the modafinil group by week 2 and maintained at week 4, 5, and 6. The response rate (>/=50% reduction in IDS) was 44% for modafinil vs. 22% for placebo treated subjects. During the 6 weeks, there was no difference between groups in treatment-emergent hypo/mania (MOD 6/41 or 14.6% / PLC 5/44 or 11.4%) or hospitalization for mania (1 MOD/ 1 PLC).
Frye MA, Grunze H, Suppes T, McElroy SL, Keck PE Jr, Walden J, Leverich GS, Altshuler LL, Nakelsky S, Hwang S, Mintz J, Post RM. A placebo-controlled evaluation of adjunctive modafinil in the treatment of bipolar depression. Am J Psychiatry. 2007 Aug;164(8):1242-9.
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