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      Quality of life in children and adolescents with bipolar I depression treated with olanzapine/fluoxetine combination

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          Abstract

          Background

          We examined the efficacy of olanzapine/fluoxetine combination (OFC) in improving health-related quality of life (QoL) in the treatment of bipolar depression in children and adolescents.

          Methods

          Patients aged 10–17 years with bipolar I disorder, depressed episode, baseline children’s depression rating scale-revised (CDRS-R) total score ≥40, Young Mania Rating Scale (YMRS) total score ≤15, and YMRS-item 1 ≤ 2 were randomized to OFC (6/25–12/50 mg/day olanzapine/fluoxetine; n = 170) or placebo (n = 85) for up to 8 weeks of double-blind treatment. Patients and parents completed the revised KINDL questionnaire for measuring health-related QoL in children and adolescents (KINDL-R) at baseline and endpoint. The mean change in CDRS-R total and item scores were used to compare improvement in symptomatology in patients taking OFC and placebo. Tests were 2-sided using a Type I error cutoff of 0.05, and no adjustments for multiple comparisons were made.

          Results

          Baseline QoL as measured by the KINDL-R was substantially impaired relative to published norms for a healthy school-based sample. OFC-treated patients demonstrated an improvement over placebo at endpoint with respect to mean change from baseline in the patient-rated KINDL-R Self-esteem subscale score ( p = 0.028), and in the parent KINDL-R ratings of emotional well-being ( p = 0.020), Self-esteem ( p = 0.030), and Family ( p = 0.006). At endpoint, OFC-treated patients still had a lower QoL compared to the normative population. OFC showed significant improvement ( p ≤ 0.05) versus placebo on the CDRS-R total score and on 7 of the 17 CDRS-R items.

          Conclusions

          Patients aged 10–17 years with an acute episode of bipolar depression and their parents reported greater improvements (parents noticed improvements in more areas than did their offspring) on some aspects of QoL when treated with OFC compared with placebo. However, after 8 weeks of treatment, KINDL-R endpoint scores remained lower than those of the, presumably healthy, control population.

          Clinical trial registration information A Study for Assessing Treatment of Patients Ages 10–17 with Bipolar Depression; http://www.clinicaltrials.gov; NCT00844857

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          Most cited references41

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          Can parents rate their child's health-related quality of life? Results of a systematic review.

          A systematic review was conducted to determine the relationship between ratings of children's health-related quality of life (HRQoL) made by parents and children. This was investigated in relation to four questions: is agreement greater for some domains (e.g. physical HRQoL) than others?; do parents perceive illness to have a greater impact than their child?; how is agreement affected by child age, gender and illness status?; and is the relationship between proxy ratings affected by the method of data collection? Fourteen studies were identified. Consistent with previous research, there was greater agreement for observable functioning (e.g. physical HRQoL), and less for non-observable functioning (e.g. emotional or social HRQoL). Three studies assessed whether parents perceive the illness to have a greater impact than their child, but no clear conclusions could be drawn given differences in measures used. Agreement is better between parents and chronically sick children compared with parents and their healthy children, but no effects were found for age or gender. All of these results may be dependent on the specific measure of HRQoL employed. There remain strong arguments for obtaining information from both parents and children whenever possible.
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            A double-blind, randomized, placebo-controlled trial of fluoxetine in children and adolescents with depression.

            Depression is a major cause of morbidity and mortality in children and adolescents. To date, randomized, controlled, double-blind trials of antidepressants (largely tricyclic agents) have yet to reveal that any antidepressant is more effective than placebo. This article is of a randomized, double-blind, placebo-controlled trial of fluoxetine in children and adolescents with depression. Ninety-six child and adolescent outpatients (aged 7-17 years) with nonpsychotic major depressive disorder were randomized (stratified for age and sex) to 20 mg of fluoxetine or placebo and seen weekly for 8 consecutive weeks. Randomization was preceded by 3 evaluation visits that included structured diagnostic interviews during 2 weeks, followed 1 week later by a 1-week, single-blind placebo run-in. Primary outcome measurements were the global improvement of the Clinical Global Impressions scale and the Children's Depression Rating Scale--Revised, a measure of the severity depressive symptoms. Of the 96 patients, 48 were randomized to fluoxetine treatment and 48 to placebo. Using the intent to treat sample, 27 (56%) of those receiving fluoxetine and 16 (33%) receiving placebo were rated "much" or "very much" improved on the Clinical Global Impressions scale at study exit (chi 2 = 5.1, df = 1, P = .02). Significant differences were also noted in weekly ratings of the Children's Depression Rating Scale--Revised after 5 weeks of treatment (using last observation carried forward). Equivalent response rates were found for patients aged 12 years and younger (n = 48) and those aged 13 years and older (n = 48). However, complete symptom remission (Children's Depression Rating Scale--Revised < or = 28) occurred in only 31% of the fluoxetine-treated patients and 23% of the placebo patients. Fluoxetine was superior to placebo in the acute phase treatment of major depressive disorder in child and adolescent outpatients with severe, persistent depression. Complete remission of symptoms was rare.
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              National trends in the outpatient diagnosis and treatment of bipolar disorder in youth.

              Although bipolar disorder may have its onset during childhood, little is known about national trends in the diagnosis and management of bipolar disorder in young people. To present national trends in outpatient visits with a diagnosis of bipolar disorder and to compare the treatment provided to youth and adults during those visits. We compare rates of growth between 1994-1995 and 2002-2003 in visits with a bipolar disorder diagnosis by individuals aged 0 to 19 years vs those aged 20 years or older. For the period of 1999 to 2003, we also compare demographic, clinical, and treatment characteristics of youth and adult bipolar disorder visits. Outpatient visits to physicians in office-based practice. Patient visits from the National Ambulatory Medical Care Survey (1999-2003) with a bipolar disorder diagnosis (n = 962). Visits with a diagnosis of bipolar disorder by youth (aged 0-19 years) and by adults (aged > or = 20 years). The estimated annual number of youth office-based visits with a diagnosis of bipolar disorder increased from 25 (1994-1995) to 1003 (2002-2003) visits per 100,000 population, and adult visits with a diagnosis of bipolar disorder increased from 905 to 1679 visits per 100,000 population during this period. In 1999 to 2003, most youth bipolar disorder visits were by males (66.5%), whereas most adult bipolar disorder visits were by females (67.6%); youth were more likely than adults to receive a comorbid diagnosis of attention-deficit/hyperactivity disorder (32.2% vs 3.0%, respectively; P < .001); and most youth (90.6%) and adults (86.4%) received a psychotropic medication during bipolar disorder visits, with comparable rates of mood stabilizers, antipsychotics, and antidepressants prescribed for both age groups. There has been a recent rapid increase in the diagnosis of youth bipolar disorder in office-based medical settings. This increase highlights a need for clinical epidemiological reliability studies to determine the accuracy of clinical diagnoses of child and adolescent bipolar disorder in community practice.
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                Author and article information

                Contributors
                317-433-6757 , Walker_Daniel_J@lilly.com
                MELDELMP@UCMAIL.UC.EDU
                landry_john@lilly.com
                deborah.dsouza@inventivhealth.com
                detke_holland_c@lilly.com
                Journal
                Child Adolesc Psychiatry Ment Health
                Child Adolesc Psychiatry Ment Health
                Child and Adolescent Psychiatry and Mental Health
                BioMed Central (London )
                1753-2000
                12 July 2017
                12 July 2017
                2017
                : 11
                : 34
                Affiliations
                [1 ]ISNI 0000 0000 2220 2544, GRID grid.417540.3, , Eli Lilly and Company, Lilly Research Laboratories, Lilly Corporate Center, ; Indianapolis, IN 46285 USA
                [2 ]ISNI 0000 0001 2179 9593, GRID grid.24827.3b, Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, , University of Cincinnati College of Medicine, ; Cincinnati, OH USA
                [3 ]ISNI 0000 0004 0533 8801, GRID grid.418787.5, , Eli Lilly Canada Inc., ; Toronto, Canada
                [4 ]inVentiv Health Company, LLC, Indianapolis, IN USA
                Article
                170
                10.1186/s13034-017-0170-7
                5506697
                28706563
                c55b81b2-176f-451f-91dc-bf27da5dbc52
                © The Author(s) 2017

                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
                : 10 May 2016
                : 18 June 2017
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100004312, Eli Lilly and Company;
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2017

                Clinical Psychology & Psychiatry
                olanzapine fluoxetine combination,bipolar,depression,quality of life,children,adolescents

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