Efficacy and Safety Study of Seroquel SR in the Treatment of Major Depressive Disorder

Summary

The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR) quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve depressive symptoms in elderly patients with major depressive disorder. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Timeline

Start

2006-09

Primary completion

2007-12

Completion

2007-12

Publications

• Weisler R, Montgomery SA, Earley WR, Szamosi J, Eriksson H. Extended release quetiapine fumarate in patients with major depressive disorder: suicidality data from acute and maintenance studies. J Clin Psychiatry. 2014 May;75(5):520-7. doi: 10.4088/JCP.13m08624.
• Weisler R, McIntyre RS. The role of extended-release quetiapine fumarate monotherapy in the treatment of patients with major depressive disorder. Expert Rev Neurother. 2013 Nov;13(11):1161-82. doi: 10.1586/14737175.2013.846520.
• Montgomery SA, Altamura AC, Katila H, Datto C, Szamosi J, Eriksson H. Efficacy of extended release quetiapine fumarate monotherapy in elderly patients with major depressive disorder: secondary analyses in subgroups of patients according to baseline anxiety, sleep disturbance, and pain levels. Int Clin Psychopharmacol. 2014 Mar;29(2):93-105. doi: 10.1097/YIC.0000000000000007.
• Locklear JC, Svedsater H, Datto C, Endicott J. Effects of once-daily extended release quetiapine fumarate (quetiapine XR) on quality of life and sleep in elderly patients with major depressive disorder. J Affect Disord. 2013 Jul;149(1-3):189-95. doi: 10.1016/j.jad.2013.01.021. Epub 2013 Apr 29.
• Katila H, Mezhebovsky I, Mulroy A, Berggren L, Eriksson H, Earley W, Datto C. Randomized, double-blind study of the efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in elderly patients with major depressive disorder. Am J Geriatr Psychiatry. 2013 Aug;21(8):769-84. doi: 10.1016/j.jagp.2013.01.010. Epub 2013 Feb 6.

Drugs

Indications