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