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      Bipolar II compared with bipolar I disorder: baseline characteristics and treatment response to quetiapine in a pooled analysis of five placebo-controlled clinical trials of acute bipolar depression

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          Abstract

          Background

          Bipolar I and II represent the most common and severe subtypes of bipolar disorder. Although bipolar I disorder is relatively well studied, the clinical characteristics and response to treatment of patients with bipolar II disorder are less well understood.

          Methods

          To compare the severity and burden of illness of patients with bipolar II versus bipolar I disorder, baseline demographic, clinical, and quality of life data were examined in 1900 patients with bipolar I and 973 patients with bipolar II depression, who were enrolled in five similarly designed clinical placebo-controlled trials of quetiapine immediate-release and quetiapine extended-release. Acute (8 weeks) response to treatment was also compared by assessing rating scale scores, including Montgomery–Åsberg depression rating scale, Hamilton rating scale for anxiety, Young mania rating scale, and clinical global impression-severity scores, in the bipolar I and II populations in the same pooled database.

          Results

          Patients with bipolar I and bipolar II depression were similar in demographics, baseline rating scale scores (depression, anxiety, mania, and quality of life), and mood episode histories. Symptom improvements in response to quetiapine were greater versus comparators (lithium, paroxetine, and placebo) at 4 and 8 weeks in both bipolar I and II patients. Patients with the bipolar II subtype initially showed slower responses to all treatments, but, by 8 weeks, attained similar symptom improvement as patients with bipolar I depression.

          Conclusions

          Pooled analysis of five clinical trials of quetiapine demonstrated that patients with bipolar II depression have a similar burden of illness and quality of life to patients with bipolar I. Bipolar II patients consistently showed a slower response to treatments than bipolar I patients, but, after 8 weeks of treatment with quetiapine, symptom improvements were similar between bipolar I and II disorder subtypes.

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          Most cited references25

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          Diagnostic and statistical manual of mental disorders.

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            A rating scale for mania: reliability, validity and sensitivity.

            An eleven item clinician-administered Mania Rating Scale (MRS) is introduced, and its reliability, validity and sensitivity are examined. There was a high correlation between the scores of two independent clinicians on both the total score (0.93) and the individual item scores (0.66 to 0.92). The MRS score correlated highly with an independent global rating, and with scores of two other mania rating scales administered concurrently. The score also correlated with the number of days of subsequent stay in hospital. It was able to differentiate statistically patients before and after two weeks of treatment and to distinguish levels of severity based on the global rating.
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              Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure.

              The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-report measure designed to enable investigators to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. The summary scores were found to be reliable and valid measures of these dimensions in a group of depressed outpatients. The Q-LES-Q measures were related to, but not redundant with, measures of overall severity of illness or severity of depression within this sample. These findings suggest that the Q-LES-Q measures may be sensitive to important differences among depressed patients that are not detected by the measures usually employed.
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                Author and article information

                Contributors
                302 885-1948 , Catherine.Datto@astrazeneca.com
                William.Pottorf@astrazeneca.com
                louisafeeley@gmail.com
                etropal@verizon.net
                Charlie.Liss@astrazeneca.com
                Journal
                Ann Gen Psychiatry
                Ann Gen Psychiatry
                Annals of General Psychiatry
                BioMed Central (London )
                1744-859X
                11 March 2016
                11 March 2016
                2016
                : 15
                : 9
                Affiliations
                AstraZeneca, US Medical Affairs, 1800 Concord Pike, C2C-522, Wilmington, DE 19850 USA
                Article
                96
                10.1186/s12991-016-0096-0
                4788818
                26973704
                d8a62e0d-8307-4432-9592-68600bfc693e
                © Datto et al. 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 22 October 2015
                : 25 February 2016
                Funding
                Funded by: AstraZeneca Pharmaceuticals
                Categories
                Primary Research
                Custom metadata
                © The Author(s) 2016

                Clinical Psychology & Psychiatry
                bipolar ii disorder,quetiapine,clinical trials
                Clinical Psychology & Psychiatry
                bipolar ii disorder, quetiapine, clinical trials

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