Abstracts
3427196
(#30) ProACT: A Prospective Real-World Observational Study of Adjunctive Cariprazine Treatment for Major Depressive Disorder
Abstract: Background: Most patients with major depressive disorder (MDD) do not respond to initial antidepressant monotherapy and experience residual symptoms associated with worse clinical outcomes, impaired functioning, and reduced quality of life (QoL). Adjunctive treatment with atypical antipsychotics is a guideline-recommended option following inadequate response to antidepressant monotherapy, but there is a paucity of comprehensive research on real-world, long-term, patient-reported outcomes (PROs) following adjunctive atypical antipsychotic treatment. ProACT is an ongoing, real-world, prospective longitudinal study designed to address this gap by collecting key PROs from patients initiating adjunctive cariprazine treatment for MDD.
Methods: Survey data will be collected prospectively from commercially insured adults in the US with ≥1 antidepressant therapy and ≥1 cariprazine prescription for the treatment of MDD. Target enrollment is 450 patients (primarily recruited via AbbVie's VRAYPAY® savings program), with ~250 expected to complete the study. The primary objective is to examine PROs at baseline and at multiple timepoints up to 24 weeks after cariprazine initiation. PROs include depression severity (Patient Health Questionnaire-9), patient functioning (Functioning Assessment Short Test), QoL (12-Item Short Form Survey v2), anhedonia (Snaith-Hamilton Pleasure Scale), anxiety (General Anxiety Disorder-7), and motivation (Motivation and Energy Inventory).
Results: Final results with longitudinal changes in PROs are anticipated in December 2026, with an interim readout mid-year.
Conclusions: ProACT will provide valuable, real-world insights into patient perspectives related to functioning, QoL, and difficult-to-treat symptoms (eg, anhedonia, anxiety, motivation) during long-term adjunctive cariprazine treatment for MDD. Findings can inform clinical practice and treatment decisions.
Short Description: ProACT is an ongoing, real-world, prospective, observational study of adjunctive cariprazine treatment for major depressive disorder designed to provide valuable real-world insights into patient perspectives on key, clinically relevant outcomes. This 24-week study will survey patients before cariprazine initiation and at multiple timepoints following treatment. Target enrollment is 450 patients, with ~250 expected to complete the study. Outcomes include patient-reported measures of depression severity, functioning, quality of life, and difficult-to-treat symptoms (eg, anhedonia, anxiety, motivation).
Name of Sponsoring Organization(s): AbbVie
Methods: Survey data will be collected prospectively from commercially insured adults in the US with ≥1 antidepressant therapy and ≥1 cariprazine prescription for the treatment of MDD. Target enrollment is 450 patients (primarily recruited via AbbVie's VRAYPAY® savings program), with ~250 expected to complete the study. The primary objective is to examine PROs at baseline and at multiple timepoints up to 24 weeks after cariprazine initiation. PROs include depression severity (Patient Health Questionnaire-9), patient functioning (Functioning Assessment Short Test), QoL (12-Item Short Form Survey v2), anhedonia (Snaith-Hamilton Pleasure Scale), anxiety (General Anxiety Disorder-7), and motivation (Motivation and Energy Inventory).
Results: Final results with longitudinal changes in PROs are anticipated in December 2026, with an interim readout mid-year.
Conclusions: ProACT will provide valuable, real-world insights into patient perspectives related to functioning, QoL, and difficult-to-treat symptoms (eg, anhedonia, anxiety, motivation) during long-term adjunctive cariprazine treatment for MDD. Findings can inform clinical practice and treatment decisions.
Short Description: ProACT is an ongoing, real-world, prospective, observational study of adjunctive cariprazine treatment for major depressive disorder designed to provide valuable real-world insights into patient perspectives on key, clinically relevant outcomes. This 24-week study will survey patients before cariprazine initiation and at multiple timepoints following treatment. Target enrollment is 450 patients, with ~250 expected to complete the study. Outcomes include patient-reported measures of depression severity, functioning, quality of life, and difficult-to-treat symptoms (eg, anhedonia, anxiety, motivation).
Name of Sponsoring Organization(s): AbbVie
