Poster
53
(#53) Long-Term Efficacy of Adjunctive Cariprazine in Patients with MDD: Results From an Open-Label 26-Week Safety Study
Psych Congress 2025
Abstract: Background:This phase 3, multicenter, open-label, long-term (26-week), flexible-dose (1.5-4.5 mg/day) study assessed long-term safety and tolerability of cariprazine used adjunctively with antidepressant therapy(ADT) in adult patients with major depressive disorder(MDD) who completed a lead-in study(n=311) or newly recruited(n=131).Patients from the lead-in study completed treatment with placebo or cariprazine plus ADT.Long-term efficacy was evaluated.
Methods:Efficacy was measured by change from baseline in MADRS total and CGI-S score.MADRS response (≥50% reduction from baseline in MADRS total score) and remission (MADRS total score ≤10) rates were evaluated.The baseline efficacy was the lead-in baseline for rollover patients and the last available efficacy assessment before first dose of open-label cariprazine for new patients.Efficacy parameters were summarized using descriptive statistics for the intent-to-treat population (ITT: patients from safety population with ≥1 efficacy assessment after visit 2); no inferential statistical analyses were conducted.
Results:442 patients enrolled, 345 received open-label drug, 336 were ITT population.Baseline mean(SD) MADRS and CGI-S scores were 22.8(9.0) and 3.8(1.0), respectively.Using a last observation carried forward (LOCF) method, the mean(SD) changes from baseline to wk26 in the MADRS and the CGI-S score were −8.9(10.5) and −1.1(1.3), respectively.MADRS response rates from baseline to wk4, wk12, wk18, and wk26 were 34.8%(n=117), 43.8%(n=147), 44.0%(n=148), 47.6%(n=160), respectively.Remission rates from baseline at wk4, wk12, wk18, and wk26 were 11%(n=37), 34.8%(n=117), 42.6%(n=143), 46.4%(n=156), 45.8%(n=154), respectively.
Cconclusions:Cariprazine was generally safe and well tolerated. MADRS and CGI-S scores continually decrease during 6-month treatment, with an increasing proportion achieving MADRS response and remission.Long-term treatment was associated with a durable antidepressant effect in MDD.
Short Description: This study evaluates the long-term efficacy and safety of adjunctive cariprazine in patients with Major Depressive Disorder (MDD) over a 26-week period and demonstrated decrease in MADRS total score and CGI-S scores. Response and remission rates improved consistently over time, suggesting a durable antidepressant effect of cariprazine as a long-term adjunctive therapy in MDD. These results highlight cariprazine's potential as an effective and well-tolerated option for enhancing treatment outcomes in patients with MDD.
Name of Sponsoring Organization(s): AbbVie Inc.
Methods:Efficacy was measured by change from baseline in MADRS total and CGI-S score.MADRS response (≥50% reduction from baseline in MADRS total score) and remission (MADRS total score ≤10) rates were evaluated.The baseline efficacy was the lead-in baseline for rollover patients and the last available efficacy assessment before first dose of open-label cariprazine for new patients.Efficacy parameters were summarized using descriptive statistics for the intent-to-treat population (ITT: patients from safety population with ≥1 efficacy assessment after visit 2); no inferential statistical analyses were conducted.
Results:442 patients enrolled, 345 received open-label drug, 336 were ITT population.Baseline mean(SD) MADRS and CGI-S scores were 22.8(9.0) and 3.8(1.0), respectively.Using a last observation carried forward (LOCF) method, the mean(SD) changes from baseline to wk26 in the MADRS and the CGI-S score were −8.9(10.5) and −1.1(1.3), respectively.MADRS response rates from baseline to wk4, wk12, wk18, and wk26 were 34.8%(n=117), 43.8%(n=147), 44.0%(n=148), 47.6%(n=160), respectively.Remission rates from baseline at wk4, wk12, wk18, and wk26 were 11%(n=37), 34.8%(n=117), 42.6%(n=143), 46.4%(n=156), 45.8%(n=154), respectively.
Cconclusions:Cariprazine was generally safe and well tolerated. MADRS and CGI-S scores continually decrease during 6-month treatment, with an increasing proportion achieving MADRS response and remission.Long-term treatment was associated with a durable antidepressant effect in MDD.
Short Description: This study evaluates the long-term efficacy and safety of adjunctive cariprazine in patients with Major Depressive Disorder (MDD) over a 26-week period and demonstrated decrease in MADRS total score and CGI-S scores. Response and remission rates improved consistently over time, suggesting a durable antidepressant effect of cariprazine as a long-term adjunctive therapy in MDD. These results highlight cariprazine's potential as an effective and well-tolerated option for enhancing treatment outcomes in patients with MDD.
Name of Sponsoring Organization(s): AbbVie Inc.
