Bauer, M., Kasper, S., Dell'Osso, L., Pichot, W., Baune, B.T., Köhler, J., Jørgensen, L., Dencker-Vansvik, E., and Montgomery, S. (2010) Predictive factors of remission for treatment-resistant major depressive disorder (MDD) during treatment with extended-release quetiapine fumarate(quetiapine XR). International Journal of Psychiatry in Clinical Practice, 14 (S1). P 07. pp. 20-21.

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Abstract

Aim: To explore predictors of remission for patients with treatment-resistant MDD receiving quetiapine XR.

Methods: Post-hoc analysis of data from a 6-week, randomised, open-label, rater-blinded study (NCT00789854) in adults with treatment-resistant MDD (non-responders to 1 or 2 adequate trials of major classes of antidepressant [AD], MADRS total score ≥ 25). Treatment: add-on quetiapine XR (300 mg/day) to ongoing AD therapy, quetiapine XR monotherapy (300 mg/day) or add-on lithium (0.6–1.2 mmol/L). Primary efficacy evaluation: change in MADRS total score from randomisation to Week 6 (pre-specified non-inferiority limit 3 points). Remission definition: MADRS total score ≤ 10 points; a univariate logistic regression approach was used to determine variables predictive for remission.

Results: 688 patients randomised (add-on quetiapine XR [n = 231], quetiapine XR monotherapy [n = 228], add-on lithium [n = 229]). At Week 6, add-on quetiapine XR and quetiapine XR monotherapy were non-inferior to add-on lithium; least squares mean differences in MADRS total score changes: −2.32 (95% confidence interval [CI]: −4.6, −0.05), which is above the 2 points judged to be clinically relevant, and −0.97 (95% CI: −3.24, 1.31), respectively. MADRS remission rates: 31.9%, 23.6% and 27.1% for add-on quetiapine XR, quetiapine XR monotherapy and add-on lithium, respectively (no significant differences between groups). The post-hoc analysis identified 22/127 variables that had predictive value for remission including time since first known psychiatric disorder (p < 0.0001), time since first known depressed episode (p = 0.0001), time since first MDD diagnosis (p = 0.0016), time in present episode (p < 0.0001), state anxiety (p = 0.0438), trait anxiety (p = 0.0245) and low anxiety. Plasma lithium concentration (add-on lithium group) within the therapeutic window (0.6–1.2 mmol/L) at end-of-study was also predictive for remission (p = 0.0239), while the absolute lithium concentration was not. Sensitivity analyses showed response (> 50% improvement in MADRS total score) was predicted by the same variables as for remission.

Conclusions: Time and anxiety variables offered the greatest predictive value, with longer time or higher anxiety associated with a lower likelihood of attaining symptomatic remission or response.

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