• Mood Disorders
• Psychopharmacology
• Psychiatry Clinical Trials

• Mood Disorders
• Psychopharmacology
• Psychiatry
• Psychiatry Clinical Trials

Armodafinil 150 mg daily for 8 weeks as an adjuvant with mood stabilizers and/or antipsychotic drugs improved depressive symptoms associated with bipolar I disorder. The benefits, however, were not statistically significant compared with placebo. The findings of a multi-institutional, international, Phase 3, randomized, double-blind, placebo-controlled trial were presented by Caleb Adler, MD, University of Cincinnati, Cincinnati, Ohio, USA [APA 2014 (poster NR6–038); NCT01305408].

The study focused on depressive episodes of bipolar I disorder, which occur more frequently than the manic episodes [Kupka RW et al. Bipolar Disord 2007] and exact a toll on personal and work relationships [Calabrese JR et al. J Clin Psychiatry 2004]. The ability of armodafinil to bind to the dopamine transporter and inhibit dopamine reuptake [NUVIGIL (package insert). Frazer, PA: Cephalon, Inc; 2013] may be useful in treatment of bipolar I depression [Calabrese JR et al. J Clin Psychiatry 2010; Frye MA et al. Am J Psychiatry 2007].

Researchers screened 656 patients for the trial. All were aged 18 to 65 years, were diagnosed with bipolar I disorder, and were currently depressed for ≥2 weeks but ≤12 months despite a regimen of mood stabilizers for at least 4 weeks. Exclusion criteria included other Axis I or II disorders, psychotic symptoms or psychosis within 4 weeks of screening, suicidal ideation or a history of suicidal behavior, a Hamilton Anxiety Scale score ≥17 at baseline, and a documented drug or hypersensitivity reaction.

The 399 enrolled patients were randomly assigned to receive placebo (n=199) or armodafinil 150 mg/day (n=200). At baseline, 308 (77%) of patients were taking one mood stabilizer or antipsychotic. Patients in the two groups were similar in baseline demographic and bipolar illness characteristics (Table 1).

The primary efficacy assessment was the mean change from baseline to 8 weeks in the 30-item, clinician-rated Inventory of Depressive Symptomatology (IDS-C₃₀) score. Safety assessments included adverse events, serious adverse events, vital signs, and laboratory data.

The baseline mean IDS-C₃₀ scores were 42.4 and 43.5 in the armodafinil and placebo groups, respectively. The respective reduction in the score at 8 weeks was −20.8 and −19.4; the difference was not statistically significant (p=0.272). At 8 weeks, there were no clinically significant differences compared with baseline in serum chemistries, lipid profiles, and urinalysis parameters. Mean weight at 8 weeks was reduced in the armodafinil group by 0.5 kg and was increased in the placebo group by 0.3 kg.

Armodafinil was well tolerated. Adverse events were similar in the two groups; most were mild or moderate, and no deaths occurred.

The finding of a benefit of armodafinil that was not statistically significant from placebo calls for more research to conclusively determine the clinical value of the drug for treatment of bipolar I depression.

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