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      Cariprazine Use in Combination With a Mood Stabilizer in First Episode Mania

      brief-report

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          Abstract

          Background

          Cariprazine's efficacy and safety have been previously tested in adult patients with acute mania associated with bipolar I disorder, but there is no available data in FEM. The objective of this study is to assess the efficacy and safety of cariprazine in combination with a mood stabilizer in treating FEM as well as to evaluate patients' adherence to the treatment.

          Methods

          FEM patients were recruited from the acute inpatient unit at Lleida University Hospital Santa Maria, between January and June 2021. Their symptoms were evaluated using the Young Mania Rating Scale (YMRS) and the Clinical Global Impressions–Severity (CGI-S) scale at admission and at discharge. Akathisia was assessed using the Barnes Akathisia Rating Scale. Patient adherence to medication treatment was assessed 30 days after discharge using the Morisky, Green and Levine Medication Adherence Scale. Socio-demographic and clinical information were further collected.

          Results

          Eleven patients with FEM were involved, seven women and four men. Their mean age was 26.00+/-6.37 years. Mean hospitalization was 17.36+/−4.7 days. Cariprazine was combined with a mood stabilizer: lithium in seven patients and divalproex in four. Mean YMRS change from baseline was −24.55+/−7.5 and the mean CGI-S change from baseline was −2.55+/−0.82. Regarding adverse events, two (18.2%) patients presented with akathisia. At the 30-day treatment-adherence assessment, six (54.5%) patients were adherent and four (36.4%) had moderate adherence.

          Conclusion

          In this sample, cariprazine in combination with mood stabilizers proved to be safe and effective in the treatment of FEM with more than half the patients being adherent to treatment. Therefore, cariprazine add-on is a good choice for promoting the long-term adherence of patients, thus minimizing the risk of relapse and improving prognosis.

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          Most cited references41

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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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            Concurrent and predictive validity of a self-reported measure of medication adherence.

            Adherence to the medical regimen continues to rank as a major clinical problem in the management of patients with essential hypertension, as in other conditions treated with drugs and life-style modification. This article reviews the psychometric properties and tests the concurrent and predictive validity of a structured four-item self-reported adherence measure (alpha reliability = 0.61), which can be easily integrated into the medical visit. Items in the scale address barriers to medication-taking and permit the health care provider to reinforce positive adherence behaviors. Data on patient adherence to the medical regimen were collected at the end of a formalized 18-month educational program. Blood pressure measurements were recorded throughout a 3-year follow-up period. Results showed the scale to demonstrate both concurrent and predictive validity with regard to blood pressure control at 2 years and 5 years, respectively. Seventy-five percent of the patients who scored high on the four-item scale at year 2 had their blood pressure under adequate control at year 5, compared with 47% under control at year 5 for those patients scoring low (P less than 0.01).
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              Real-World Evidence - What Is It and What Can It Tell Us?

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                Author and article information

                Contributors
                Journal
                Front Psychiatry
                Front Psychiatry
                Front. Psychiatry
                Frontiers in Psychiatry
                Frontiers Media S.A.
                1664-0640
                11 May 2022
                2022
                : 13
                : 828088
                Affiliations
                [1] 1Department of Psychiatry, Mental Health, and Addiction, GSS–Hospital Santa Maria , Lleida, Spain
                [2] 2Department of Psychiatry, Hospital Universitari Vall d'Hebron , Barcelona, Spain
                [3] 3Psychiatry Genetics Unit, Group of Psychiatry, Mental Health and Addictions, Vall d'Hebron Research Institute (VHIR), Universitat Autònoma de Barcelona , Barcelona, Spain
                [4] 4Biomedical Network Research Center on Mental Health (CIBERSAM) , Madrid, Spain
                [5] 5Department of Psychiatry and Forensic Medicine, Universitat Autònoma de Barcelona , Barcelona, Spain
                Author notes

                Edited by: Peter Falkai, LMU Munich University Hospital, Germany

                Reviewed by: Georgios Demetrios Kotzalidis, Sapienza University of Rome, Italy; Francesco Monaco, Azienda Sanitaria Locale Salerno, Italy

                *Correspondence: Roberto Palacios-Garrán palacios.garran@ 123456gmail.com

                This article was submitted to Psychopharmacology, a section of the journal Frontiers in Psychiatry

                †These authors have contributed equally to this work and share first authorship

                Article
                10.3389/fpsyt.2022.828088
                9130589
                c090a0a0-aad5-46e3-8e4b-4d17d6798b6f
                Copyright © 2022 Palacios-Garrán, Llorca-Bofí, Arteaga-Henriquez and del Agua.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 02 December 2021
                : 15 April 2022
                Page count
                Figures: 2, Tables: 2, Equations: 0, References: 44, Pages: 7, Words: 5365
                Funding
                Funded by: Gedeon Richter, doi 10.13039/501100003358;
                Categories
                Psychiatry
                Brief Research Report

                Clinical Psychology & Psychiatry
                first episode mania,cariprazine,bipolar disoder,acute mania,presicion medicine,treatment adherence

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