Effects of asenapine on depressive symptoms in patients with bipolar I disorder experiencing acute manic or mixed episodes: a post hoc analysis of two 3-week clinical trials
2011

Asenapine's Effects on Depression in Bipolar I Disorder

Sample size: 977 publication Evidence: moderate

Author Information

Author(s): Szegedi Armin, Zhao Jun, van Willigenburg Arjen, Nations Kari R, Mackle Mary, Panagides John

Primary Institution: Merck Research Laboratories

Hypothesis

Asenapine will reduce depressive symptoms in patients with bipolar I disorder experiencing acute manic or mixed episodes.

Conclusion

Asenapine significantly reduced depressive symptoms in bipolar I disorder patients with acute manic or mixed episodes, while olanzapine's effects were less consistent.

Supporting Evidence

  • Asenapine showed greater reductions in MADRS total scores compared to placebo at days 7 and 21.
  • Remission rates for MADRS total scores ≤12 were significantly higher with asenapine than placebo.
  • Changes in CGI-BP-D scores were significantly greater with asenapine compared to placebo.

Takeaway

Asenapine helps people with bipolar disorder feel less sad when they are having a tough time with their mood.

Methodology

The study analyzed data from two 3-week trials where patients were given asenapine, placebo, or olanzapine and assessed for changes in depressive symptoms.

Potential Biases

Potential bias due to the exploratory nature of the post hoc analysis.

Limitations

The analysis was post hoc and based on a subset of patients, which may not represent the broader population.

Participant Demographics

Patients were adults with bipolar I disorder experiencing manic or mixed episodes, with a mean age around 39 years.

Statistical Information

P-Value

0.002

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/1471-244X-11-101

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