A placebo controlled study of quetiapine-XR in bipolar depression accompanied by generalized anxiety with and without a recent history of alcohol and cannabis use
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This study aims to compare treatment response in bipolar I or II depression and generalized anxiety disorder (GAD) with and without recent alcohol and/or cannabis use disorder (ALC/CAN) to quetiapine-XR (extended release) or placebo.
A randomized, double-blind, 8-week study of quetiapine-XR versus placebo in patients with bipolar I or II depression and GAD with or without a recent ALC/CAN was used to compare changes in Hamilton Depression Rating Scale-17, Hamilton Anxiety Rating Scale, the 16-item Quick Inventory of Depressive Symptomatology–Self-Report (QIDS-SR-16), Clinical Global Impression for Bipolar Disorder-Severity (CGI-BP-S), and Timeline Follow Back within and between groups.
In the quetiapine-XR group, patients with a recent ALC/CAN (n = 22) had significant decreases in QIDS-SR-16 (−9.6 ± 1.6 vs. −3.7 ± 1.7) and CGI-BP-S (−1.6 ± 0.4 vs. −0.8 ± 0.03) than those without a recent ALC/CAN (n = 24). In the placebo group, both patients with a recent ALC/CAN (n = 23) and those without (n = 21) had similar reductions in these measures. The reduction of QIDS-SR-16 scores in patients with a recent ALC/CAN was also significantly different from that of their counterparts in the placebo group. Patients who received quetiapine-XR had larger decreases in the number of drinking days/week (p = 0.17) and number of cannabis joints/week (p = 0.09) compared to those who received placebo.
Quetiapine-XR was superior to placebo in reducing QIDS-SR-16 total score in patients with a recent ALC/CAN. Patients taking quetiapine-XR used less alcohol and cannabis than patients on placebo, suggesting that quetiapine-XR may be of use in patients with bipolar disorder accompanied by GAD and other comorbidities.
KeywordsBipolar disorder Quetiapine Generalized anxiety disorder Substance use disorder Randomized Placebo-controlled trial
Compliance with ethical standards
Disclosure of conflict of interest
J.R.C. has received federal funding from the Department of Defense, Health Resources Services Administration and National Institute of Mental Health as well as grant support from Abbott Laboratories; AstraZeneca; Bristol-Myers Squibb Company; Cephalon, Inc. (now Teva Pharmaceutical Industries Ltd.); Dainippon Sumitomo Pharma Co., Ltd.; GlaxoSmithKline; Janssen Pharmaceuticals, Inc.; Eli Lilly and Company; Intra-Cellular Therapies, Inc.; Pfizer, Inc.; H. Lundbeck A/S; Sunovion Pharmaceuticals Inc.; and Takeda Pharmaceutical Company Limited. J.R.C. has served as a consultant/advisory board member/speaker for Abbott Laboratories; Allergan; AstraZeneca; Bristol-Myers Squibb Company; Cephalon, Inc. (now Teva Pharmaceutical Industries Ltd.); Dainippon Sumitomo Pharma Co., Ltd.; GlaxoSmithKline; Janssen Pharmaceuticals, Inc.; H. Lundbeck A/S; Merck & Co., Inc.; Otsuka Pharmaceutical Co., Ltd.; Pfizer, Inc.; Repligen Corporation; Servier; Sunovion Pharmaceuticals Inc.; Solvay Pharmaceuticals, Inc.; and Takeda Pharmaceutical Company Limited.
K.G. has been on a speakers bureau and an advisory board of Sunovion, and received grant support from AstraZeneca, Brain and Behavior Research Foundation, and Cleveland Foundation.
S.J.G. has received grant support from AstraZeneca and Eli Lilly and Company.
Other authors have no conflicts of interest to disclose.
This study was initiated with a Young Investigator Award from NARSAD (currently Brain and Behavior Research Foundation) and further supported by AstraZeneca Pharmaceutical Company via an Investigator Initiated Study.
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