Comparative effectiveness and safety of cariprazine and lamotrigine in patients of bipolar depression: a prospective, randomized and open label study
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20253377Keywords:
Bipolar depression, Cariprazine, Lamotrigine, Severity dependence scaleAbstract
Background: Bipolar disorder is marked by significant shifts in mood, energy, and behaviour. Cariprazine, a D3/D2 (dopamine) partial agonist, was FDA-approved in 2019 for treating bipolar depression, though clinical trial results have been mixed. Given this variability, the present study compared the effectiveness and safety of cariprazine monotherapy with lamotrigine in patients with bipolar depression.
Methods: Study was conducted for a total duration of 90 days comprising of 70 patients form either sex (18-65 years), diagnosed with bipolar depression. Patients were randomized into group A and group B homogenously. Group A patients were given cariprazine monotherapy at 1.5 mg/day, which was increased to 3 mg/day on day 31st. Similarly, for group B, lamotrigine monotherapy was administered at 50 mg/day and the dose was increased to 100 mg/day on day 31st.
Results: Treatment significantly lowered MADRS in intra and intergroup comparison (p<0.001). However, the p values differed for different time points on assessment of CGI-I despite being statistically significant (p<0.05; p<0.001). The prevalence of substance abuse in was reported to be 25%. SDS-S results for substance use were non-significant (p>0.05). Group B reported more adverse events than group A.
Conclusions: Cariprazine led to faster and greater reduction in depressive symptoms than lamotrigine in bipolar I depression. Both were well tolerated with similar safety profiles. Substance use was low in both groups, with slightly better improvement in dependence scores seen with cariprazine.
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