Summary

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• Exxua (gepirone) is indicated for the treatment of major depressive disorder (MDD) in adults.
• This summary is based on the review of one systematic review(s)/meta-analysis(es). 3. 5-HT1A agonists, including gepirone, were significantly more effective than placebo in treating major depressive disorder (MDD) with a risk ratio (RR) of 0.74 (95% CI 0.65-0.83, p < 0.00001); the Number Needed to Treat (NNT) was 6. They also showed superiority over placebo in reducing discontinuation due to inefficacy (RR 0.49, p = 0.02). ^[1]
• No statistically significant effect was found for 5-HT1A agonist augmentation therapies on response rate (RR 0.98, p = 0.85). 5. 5-HT1A agonists led to a higher rate of discontinuation due to side-effects compared to placebo (RR 1.88, p < 0.0001), with a Number Needed to Harm (NNH) of 17. Common side-effects included gastrointestinal symptoms, dizziness, insomnia, palpitations, paresthesia, and sweating (p < 0.00001 to p = 0.03). There was no significant difference in all-cause discontinuation between 5-HT1A agonists and placebo (RR 0.99, p = 0.85).
• There is no population type or subgroup information available in the reviewed studies.