A new study by Gary Sachs and team showed that adults with major depressive disorder and poor response to antidepressants alone were treated with adjunctive cariprazine at a dose of 1.5 mg/day, which showed effectiveness in lowering depressed symptoms. The findings of this study were published in The American journal of Psychiatry.
The goal of this study was to determine whether cariprazine, a partial agonist of the dopamine D3/D2 and serotonin 5-HT1A receptors that prefers dopamine D3, is effective as an adjunctive treatment for people with major depressive disorder who have not responded to at least one antidepressant monotherapy.
Adults with severe depressive illness with poor response to antidepressants alone were randomized in this double-blind, placebo-controlled research in a 1:1:1 ratio to placebo, cariprazine at 1.5 mg/day, or cariprazine at 3.0 mg/day. The Montgomery-Sberg Depression Rating Scale total score change from baseline to week six was the main result (MADRS). In the modified intent-to-treat (mITT) population, least-squares mean differences were calculated using a mixed-effects model for repeated measurements with multiple comparisons correction.
The key findings of this study were;
The mITT group comprised 751 individuals (placebo: N=249; cariprazine 1.5 mg/day: N=250; cariprazine 3.0 mg/day: N=252).
In week 6, cariprazine 1.5 mg/day substantially outperformed placebo in terms of mean decrease from baseline in MADRS total score (14.1 vs. 11.5), but not cariprazine 3.0 mg/day (13.1).
In weeks 2 and 4, there were significant differences between the cariprazine 1.5 mg/day and placebo groups.
Patients receiving cariprazine 1.5 mg/day were substantially more likely than placebo-treated individuals to meet the MADRS response criteria (44.0% vs. 34.9%); remission rates were not statistically different between groups.
Akathisia and nausea were frequent treatment-emergent side effects (5% in either cariprazine group and double the incidence of placebo).
In conclusion, Cariprazine had a safety profile that was consistent with earlier findings, and it was typically well tolerated.
Reference:
Sachs, G. S., Yeung, P. P., Rekeda, L., Khan, A., Adams, J. L., & Fava, M. (2023). Adjunctive Cariprazine for the Treatment of Patients With Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study. In American Journal of Psychiatry (Vol. 180, Issue 3, pp. 241–251). American Psychiatric Association Publishing. https://doi.org/10.1176/appi.ajp.20220504