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Longitudinally Measured Changes in Somnolence Severity With a Visual Analog Scale in a Randomized Lithium Versus Quetiapine-IR Study in Bipolar Disorder

Gao, Keming, MD, PhD*; Su, Meilei, MD, MS; Ganocy, Stephen J., PhD*; Goto, Toyomi, MA*; Yuan, Chengmei, MD, PhD; Fang, Fang, MD, MS§; Conroy, Carla, MPH*; Brownrigg, Brittany, BS*; Serrano, Mary Beth, MA*; Calabrese, Joseph R., MD*

Journal of Clinical Psychopharmacology: May/June 2019 - Volume 39 - Issue 3 - p 249–253
doi: 10.1097/JCP.0000000000001031
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Objective The aim of this study was to use a visual analog scale (VAS) longitudinally measuring somnolence severity in patients with bipolar disorder.

Methods A data set of patients with bipolar spectrum disorders who were randomized to lithium or quetiapine-IR for 16 weeks was used. The somnolence severity was measured with a VAS from 0 to 100 (VAS based), and somnolence frequency was recorded according to incident report (incidence based) at each visit. The rates of VAS-based and incidence-based somnolence and changes in somnolence severity from baseline to the end of study were compared between the lithium and quetiapine groups. Longitudinal changes in somnolence severity were analyzed with linear regression analysis.

Results Of 42 patients randomized, only 3 scored 0 on the VAS at baseline. The rates of incidence-based and VAS-based somnolence were similar in the lithium and quetiapine-IR groups. The VAS change scores from baseline to each visit varied in both groups with significant decreases at weeks 6 and 12 in the quetiapine-IR group only. The decrease at week 6 in the quetiapine-IR group was significantly different from that in the lithium group. Patterns of changes in somnolence severity were inconsistent in both groups. A significant interaction between time course and the decrease in VAS scores was observed in the quetiapine-IR group, but not in the lithium group.

Conclusions Baseline somnolence was highly prevalent in patients with bipolar disorder. The change in somnolence severity was different between lithium-treated and quetiapine-treated patients. Quantifying somnolence longitudinally is important in clinical trials and practice.

From the *Mood and Anxiety Clinic in the Mood Disorder Program, Department of Psychiatry, University Hospitals Cleveland Medical Center/Case Western Reserve University School of Medicine, Cleveland, OH; and

Department of Psychiatry, Nanfang Hospital, Southern Medical University, Guangzhou; and

Division of Mood Disorders Program, Shanghai Mental Health Center, Shanghai Jiaotong University; and

§Department of Psychiatry, Hongkou District Mental Health Center of Shanghai, Shanghai, China.

Received October 30, 2018; accepted after revision February 28, 2019.

Reprints: Keming Gao, MD, PhD, 10524 Euclid Ave, 12 Floor, Cleveland, OH 44106 (e-mail: keming.gao@uhhospitals.org).

K.G. and M.S. contributed equally to this work.

This study was supported by a grant of the Young Investigator Award from Brain and Behavior Research Foundation and a grant from the Cleveland Foundation.

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