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Efficacy and tolerability of extended release quetiapine fumarate monotherapy as maintenance treatment of major depressive disorder: a randomized, placebo-controlled trial.
Depress Anxiety. 2010 Oct; 27(10):964-76.DA

Abstract

PRIMARY OBJECTIVE

evaluate the efficacy (time to recurrence of depressive symptoms) of once daily extended release quetiapine fumarate (quetiapine XR) as maintenance monotherapy treatment to prevent relapse for major depressive disorder (MDD).

METHODS

Time-to-event (maximum 52 weeks), double-blind, multicenter, randomized withdrawal, placebo-controlled study of quetiapine XR (50-300 mg/day) comprising four treatment phases: enrollment (up to 28 days), open-label run-in (4-8 weeks), open-label stabilization (12-18 weeks), and randomization (up to 52 weeks). Seven hundred and seventy-six patients stabilized on quetiapine XR were eligible for randomization (Montgomery-Åsberg Depression Rating Scale [MADRS] score ≤12 and Clinical Global Impression-Severity of Illness [CGI-S] score ≤3); 391 received quetiapine XR and 385 received placebo (same dose as last open-label visit). Primary endpoint: time to recurrence of depressive event from randomization. Secondary outcomes included changes from randomization in MADRS total, CGI-S, Pittsburgh Sleep Quality Index (PSQI) global, and Hamilton Anxiety Rating Scale (HAM-A) total scores. Adverse events were recorded throughout.

RESULTS

Risk of recurrence of depressive event was significantly (P<.001) reduced by 66% (HR=.34; 95% CI: .25, .46) in patients randomized to continue with quetiapine XR versus patients randomized to switch to placebo. During the randomized phase, quetiapine XR maintained improvements in secondary outcomes (P<.001 for all): MADRS (0.15 versus 2.03), CGI-S (-0.03 versus 0.23); PSQI global (0.06 versus 1.35), and HAM-A total score (0.20 versus 1.58), respectively. The most common AEs (>10% any group) during the randomized period were headache and insomnia.

CONCLUSIONS

Quetiapine XR maintenance therapy significantly reduced the risk of a depressive event in patients with MDD stabilized on quetiapine XR, with a safety and tolerability profile consistent with the known profile of quetiapine.

Authors+Show Affiliations

Department of Psychiatry, Columbia University, New York, New York 10128, USA. mrl1945@aol.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20734365

Citation

Liebowitz, Michael, et al. "Efficacy and Tolerability of Extended Release Quetiapine Fumarate Monotherapy as Maintenance Treatment of Major Depressive Disorder: a Randomized, Placebo-controlled Trial." Depression and Anxiety, vol. 27, no. 10, 2010, pp. 964-76.
Liebowitz M, Lam RW, Lepola U, et al. Efficacy and tolerability of extended release quetiapine fumarate monotherapy as maintenance treatment of major depressive disorder: a randomized, placebo-controlled trial. Depress Anxiety. 2010;27(10):964-76.
Liebowitz, M., Lam, R. W., Lepola, U., Datto, C., Sweitzer, D., & Eriksson, H. (2010). Efficacy and tolerability of extended release quetiapine fumarate monotherapy as maintenance treatment of major depressive disorder: a randomized, placebo-controlled trial. Depression and Anxiety, 27(10), 964-76. https://doi.org/10.1002/da.20740
Liebowitz M, et al. Efficacy and Tolerability of Extended Release Quetiapine Fumarate Monotherapy as Maintenance Treatment of Major Depressive Disorder: a Randomized, Placebo-controlled Trial. Depress Anxiety. 2010;27(10):964-76. PubMed PMID: 20734365.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and tolerability of extended release quetiapine fumarate monotherapy as maintenance treatment of major depressive disorder: a randomized, placebo-controlled trial. AU - Liebowitz,Michael, AU - Lam,Raymond W, AU - Lepola,Ulla, AU - Datto,Catherine, AU - Sweitzer,Dennis, AU - Eriksson,Hans, PY - 2010/8/25/entrez PY - 2010/8/25/pubmed PY - 2011/2/1/medline SP - 964 EP - 76 JF - Depression and anxiety JO - Depress Anxiety VL - 27 IS - 10 N2 - PRIMARY OBJECTIVE: evaluate the efficacy (time to recurrence of depressive symptoms) of once daily extended release quetiapine fumarate (quetiapine XR) as maintenance monotherapy treatment to prevent relapse for major depressive disorder (MDD). METHODS: Time-to-event (maximum 52 weeks), double-blind, multicenter, randomized withdrawal, placebo-controlled study of quetiapine XR (50-300 mg/day) comprising four treatment phases: enrollment (up to 28 days), open-label run-in (4-8 weeks), open-label stabilization (12-18 weeks), and randomization (up to 52 weeks). Seven hundred and seventy-six patients stabilized on quetiapine XR were eligible for randomization (Montgomery-Åsberg Depression Rating Scale [MADRS] score ≤12 and Clinical Global Impression-Severity of Illness [CGI-S] score ≤3); 391 received quetiapine XR and 385 received placebo (same dose as last open-label visit). Primary endpoint: time to recurrence of depressive event from randomization. Secondary outcomes included changes from randomization in MADRS total, CGI-S, Pittsburgh Sleep Quality Index (PSQI) global, and Hamilton Anxiety Rating Scale (HAM-A) total scores. Adverse events were recorded throughout. RESULTS: Risk of recurrence of depressive event was significantly (P<.001) reduced by 66% (HR=.34; 95% CI: .25, .46) in patients randomized to continue with quetiapine XR versus patients randomized to switch to placebo. During the randomized phase, quetiapine XR maintained improvements in secondary outcomes (P<.001 for all): MADRS (0.15 versus 2.03), CGI-S (-0.03 versus 0.23); PSQI global (0.06 versus 1.35), and HAM-A total score (0.20 versus 1.58), respectively. The most common AEs (>10% any group) during the randomized period were headache and insomnia. CONCLUSIONS: Quetiapine XR maintenance therapy significantly reduced the risk of a depressive event in patients with MDD stabilized on quetiapine XR, with a safety and tolerability profile consistent with the known profile of quetiapine. SN - 1520-6394 UR - https://www.unboundmedicine.com/medline/citation/20734365/Efficacy_and_tolerability_of_extended_release_quetiapine_fumarate_monotherapy_as_maintenance_treatment_of_major_depressive_disorder:_a_randomized_placebo_controlled_trial_ L2 - https://doi.org/10.1002/da.20740 DB - PRIME DP - Unbound Medicine ER -