Adjunctive cariprazine reduces symptoms in adult patients with major depressive disorder

Written By :  Jacinthlyn Sylvia
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2023-04-09 14:30 GMT   |   Update On 2023-10-26 11:50 GMT
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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.

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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

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Article Source : The American Journal of Psychiatry

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