Louisa G Sylvia1, Weilynn C Chang2, Masoud Kamali3, Mauricio Tohen4, Gustavo Kinrys3, Thilo Deckersbach3, Joseph R Calabrese5, Michael E Thase6, Noreen Reilly-Harrington3, William V Bobo7, James H Kocsis8, Melvin G McInnis9, Charles L Bowden10, Terence A Ketter11, Edward S Friedman12, Richard C Shelton13, Susan L McElroy14, Keming Gao5, Dustin J Rabideau15, Andrew A Nierenberg3. 1. Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: lsylvia2@partners.org. 2. Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA. 3. Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. 4. Department of Psychiatry & Behavioral Sciences, University of New Mexico, Health Sciences Center, Albuquerque, NM, USA. 5. Mood Disorders Program University Hospital's Case Medical Center,Center, Case Western Reserve University, Cleveland, OH, USA. 6. Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA, USA. 7. Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN, USA. 8. Department of Psychiatry, Weill Cornell Medical College, Ithaca, NY, USA. 9. Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA. 10. Department of Psychiatry, University of Texas Health Science Center, San Antonio, TX, USA. 11. Department of Psychiatry & Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA. 12. University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. 13. Mood Disorders Program, University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA. 14. Lindner Center of HOPE, Mason, OH, USA; Department of Psychiatry, University of Cincinnati College of Medicine, Cincinnati, OH, USA. 15. Biostatistics Center, Massachusetts General Hospital, Boston, MA, USA.
Abstract
BACKGROUND:Bipolar patients experience sleep disturbances during and between mood episodes. Yet the impact of sleep on treatment with different medications has not been fully explored. The purpose of this paper is to explore the potential impact of poor sleep at baseline on outcomes in a randomized effectiveness trial of quetiapine and lithium. METHODS: The Bipolar CHOICE study was a 6-month, parallel group, multisite randomized controlled trial. Participants with bipolar disorder (N = 482; 59% female and age 18-70 years) received quetiapine or lithium. Patients were allowed to also receive adjunctive personalized treatments, which were guideline-informed, empirically-based medications added to treatment as needed. Medication changes were recorded as necessary clinical adjustments (NCA). Fisher's exact tests, mixed-regression models, and Mann-Whitney U tests were used to assess demographic and clinical characteristics as well as whether sleep disturbance would predict outcomes. RESULTS: 63% of patients had baseline sleep disturbance. Individuals with sleep disturbance had worse bipolar illness severity, greater severity of depression, mania, anxiety, irritability, and psychosis, were less likely to have sustained response (17% vs. 29%; adjusted RR: 0.55, 95% CI: 0.38-0.78, p = 0.0006) and had more NCAs (median 0.71 vs. 0.59, p = 0.03). LIMITATIONS: Our findings were limited by how we defined sleep disturbance, and by how severity of sleep disturbance was assessed with one item with a non-sleep specific measure. CONCLUSIONS:Baseline sleep disturbance was associated with more severe bipolar symptoms and worse 6-month outcomes. Further research is warranted on improving sleep in bipolar disorder, especially the role of psychosocial interventions.
RCT Entities:
BACKGROUND: Bipolar patients experience sleep disturbances during and between mood episodes. Yet the impact of sleep on treatment with different medications has not been fully explored. The purpose of this paper is to explore the potential impact of poor sleep at baseline on outcomes in a randomized effectiveness trial of quetiapine and lithium. METHODS: The Bipolar CHOICE study was a 6-month, parallel group, multisite randomized controlled trial. Participants with bipolar disorder (N = 482; 59% female and age 18-70 years) received quetiapine or lithium. Patients were allowed to also receive adjunctive personalized treatments, which were guideline-informed, empirically-based medications added to treatment as needed. Medication changes were recorded as necessary clinical adjustments (NCA). Fisher's exact tests, mixed-regression models, and Mann-Whitney U tests were used to assess demographic and clinical characteristics as well as whether sleep disturbance would predict outcomes. RESULTS: 63% of patients had baseline sleep disturbance. Individuals with sleep disturbance had worse bipolar illness severity, greater severity of depression, mania, anxiety, irritability, and psychosis, were less likely to have sustained response (17% vs. 29%; adjusted RR: 0.55, 95% CI: 0.38-0.78, p = 0.0006) and had more NCAs (median 0.71 vs. 0.59, p = 0.03). LIMITATIONS: Our findings were limited by how we defined sleep disturbance, and by how severity of sleep disturbance was assessed with one item with a non-sleep specific measure. CONCLUSIONS: Baseline sleep disturbance was associated with more severe bipolar symptoms and worse 6-month outcomes. Further research is warranted on improving sleep in bipolar disorder, especially the role of psychosocial interventions.
Authors: Christopher N Kaufmann; Marina Z Nakhla; Ellen E Lee; Ho-Kyoung Yoon; David Wing; Colin A Depp; Lisa T Eyler Journal: J Affect Disord Date: 2019-03-05 Impact factor: 4.839
Authors: Benjamin I Goldstein; Bernhard T Baune; David J Bond; Pao-Huan Chen; Lisa Eyler; Andrea Fagiolini; Fabiano Gomes; Tomas Hajek; Jessica Hatch; Susan L McElroy; Roger S McIntyre; Miguel Prieto; Louisa G Sylvia; Shang-Ying Tsai; Andrew Kcomt; Jess G Fiedorowicz Journal: Bipolar Disord Date: 2020-06-08 Impact factor: 6.744
Authors: Christopher N Kaufmann; Ellen E Lee; David Wing; Ashley N Sutherland; Celestine Christensen; Sonia Ancoli-Israel; Colin A Depp; Ho-Kyoung Yoon; Benchawanna Soontornniyomkij; Lisa T Eyler Journal: J Psychiatr Res Date: 2021-06-21 Impact factor: 5.250