Bipolar depression: safety and efficacy of adjunctive modafinil/armodafinil therapy

  • Nunez N & al.
  • Bipolar Disord
  • 23 Oct 2019

  • curated by Sarfaroj Khan
  • UK Clinical Digest
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Takeaway

  • This meta-analysis supports the efficacy and safety of modafinil/armodafinil (MoArm) as an adjunctive treatment for bipolar depression.

Why this matters

  • Findings line with and add to the previous meta-analysis which highlighted the efficacy of modafinil and armodafinil as an augmentation strategy for both unipolar and bipolar depression.

Study design

  • 5 randomised controlled trials (n=795, MoArm; n=792, placebo) met eligibility criteria after a search across electronic databases.
  • Main outcomes: clinical response and remission rate.
  • Safety outcomes: all-cause discontinuation rate and the risk for mood switch, suicide attempts and adverse events (AEs).
  • Funding: The Marriot Grant Foundation.

Key results

  • Adjunctive MoArm vs placebo group showed a significantly greater clinical response (relative risk [RR], 1.18; 95% CI, 1.01-1.37; P=.03) and remission rate (RR, 1.38; 95% CI, 1.10-1.73; P=.005) in depressive symptoms.
  • MoArm vs placebo group did not differ in:
    • all-cause discontinuation rate (RR, 1.08; 95% CI, 0.89-1.30; P=.45);
    • the risk for mood switch (RR, 0.99; 95% CI, 0.39-2.5; P=.98); and
    • suicide attempts (RR, 1.02; 95% CI, 0.37-2.85; P=.97).
  • A statistically significant difference was observed between MoArm vs placebo group in gastrointestinal AEs such as:
    • dry mouth (RR, 2.18; 95% CI, 1.11-4.29; P=.02);
    • nausea (RR, 1.72; 95% CI, 1.09-2.73; P=.02); and
    • lower risk for weight gain (RR, 0.34; 95% CI, 0.15-0.76; P=.009).

Limitations

  • Small number of studies.
  • Subgroup analysis for modafinil vs armodafinil or differences between bipolar subtypes were not performed.