This work may not be copied, distributed, displayed, published, reproduced, transmitted, modified, posted, sold, licensed, or used for commercial purposes. By downloading this file, you are agreeing to the publisher’s Terms & Conditions.

Original Research

Efficacy and Safety of Quetiapine-XR as Monotherapy or Adjunctive Therapy to a Mood Stabilizer in Acute Bipolar Depression With Generalized Anxiety Disorder and Other Comorbidities: A Randomized, Placebo-Controlled Trial

Keming Gao, MD, PhD; Renrong Wu, MD, PhD; David E. Kemp, MD, MS; Jun Chen, MD, PhD; Elizabeth Karberg, MA; Carla Conroy, BA; Philip Chan, MS; Ming Ren, MD, PhD; Mary Beth Serrano, MA; Stephen J Ganocy, PhD; and Joseph R. Calabrese, MD

Published: June 24, 2014

Article Abstract

Objective: To study the efficacy and safety of quetiapine-XR as monotherapy or adjunctive therapy to a mood stabilizer in acute bipolar I or II depression with comorbid generalized anxiety disorder (GAD) and other comorbidities.

Method: The study was conducted from January 2007 to November 2011. The Mini-International Neuropsychiatric Interview was used to ascertain the diagnosis of DSM-IV bipolar disorder, GAD, and other Axis I disorders. Eligible patients were randomly assigned to quetiapine-XR or placebo for up to 8 weeks. The Hamilton Depression Rating Scale−17 items (HDRS-17) was used as a primary outcome to evaluate the difference between the 2 groups using the change from baseline to end of study. Last observation carried forward and mixed-effects modeling for repeated measures were used to analyze the primary and secondary outcome measures.

Results: Of the 120 patients screened, 100 patients were randomized to receive quetiapine-XR (n = 50) or placebo (n = 50). Twenty-six patients in the quetiapine-XR and 18 in the placebo group completed the study. The mean quetiapine-XR dose was 276 ± 50 mg/d (50-300 mg/d). There was no significant difference between the 2 groups in the change from baseline to end of study in HDRS-17 total score with an effect size of 0.19 favoring quetiapine-XR. There were also no significant differences between the 2 groups in secondary efficacy and safety outcome measures.

Conclusions: Quetiapine-XR was not significantly superior to placebo in bipolar I or II depression with GAD and other comorbidities, suggesting that data from relatively “pure” bipolar patients may not be generalizable to a highly comorbid population.

Trial Registration: identifier: NCT00671853

Volume: 75

Quick Links:

Continue Reading…

Subscribe to read the entire article


Buy this Article as a PDF