The efficacy of cariprazine on function in patients with bipolar depression: a post hoc analysis of a randomized controlled trial

References

• Miller S, Dell'Osso B, Ketter TA. The prevalence and burden of bipolar depression. J Affect Disord. 2014;169 (Suppl 1):S3–S11.
   PubMed Web of Science ®Google Scholar
• MacQueen GM, Young LT, Joffe RT. A review of psychosocial outcome in patients with bipolar disorder. Acta Psychiatr Scand. 2001;103(3):163–170.
   PubMed Web of Science ®Google Scholar
• Tohen M, Hennen J, Zarate CM, Jr, et al. Two-year syndromal and functional recovery in 219 cases of first-episode major affective disorder with psychotic features. Am J Psychiatry. 2000;157(2):220–228.
   PubMed Web of Science ®Google Scholar
• Tohen M, Waternaux CM, Tsuang MT. Outcome in mania. A 4-year prospective follow-up of 75 patients utilizing survival analysis. Arch Gen Psychiatry. 1990;47(12):1106–1111.
   PubMed Web of Science ®Google Scholar
• Tohen M, Waternaux CM, Tsuang MT, et al. Four-year follow-up of twenty-four first-episode manic patients. J Affect Disord. 1990;19(2):79–86.
   PubMed Web of Science ®Google Scholar
• Zarate CA, Jr., Tohen M, Land M, et al. Cognition in bipolar disorder. Psychiatr Q. 2000;71(4):309–329.
   PubMed Web of Science ®Google Scholar
• Rosa AR, Sanchez-Moreno J, Martinez-Aran A, et al. Validity and reliability of the Functioning Assessment Short Test (FAST) in bipolar disorder. Clin Pract Epidemiol Ment Health. 2007;3(1):5.
   PubMedGoogle Scholar
• Rosa AR, Reinares M, Franco C, et al. Clinical predictors of functional outcome of bipolar patients in remission. Bipolar Disord. 2009;11(4):401–409.
   PubMed Web of Science ®Google Scholar
• Bonnin CM, Martinez-Aran A, Torrent C, et al. Clinical and neurocognitive predictors of functional outcome in bipolar euthymic patients: a long-term, follow-up study. J Affect Disord. 2010;121(1–2):156–160.
   PubMed Web of Science ®Google Scholar
• Calabrese JR, Hirschfeld RM, Frye MA, et al. Impact of depressive symptoms compared with manic symptoms in bipolar disorder: results of a U.S. community-based sample. J Clin Psychiatry. 2004;65(11):1499–1504.
   PubMed Web of Science ®Google Scholar
• Gitlin MJ, Mintz J, Sokolski K, et al. Subsyndromal depressive symptoms after symptomatic recovery from mania are associated with delayed functional recovery. J Clin Psychiatry. 2011;72(05):692–697.
   PubMed Web of Science ®Google Scholar
• Merikangas KR, Akiskal HS, Angst J, et al. Lifetime and 12-month prevalence of bipolar spectrum disorder in the National Comorbidity Survey replication. Arch Gen Psychiatry. 2007;64(5):543–552.
   PubMed Web of Science ®Google Scholar
• McIntyre RS. Understanding needs, interactions, treatment, and expectations among individuals affected by bipolar disorder or schizophrenia: the UNITE global survey. J Clin Psychiatry. 2009;70(Suppl 3):5–11.
   PubMed Web of Science ®Google Scholar
• Sanchez-Moreno J, Martinez-Aran A, Tabares-Seisdedos R, et al. Functioning and disability in bipolar disorder: an extensive review. Psychother Psychosom. 2009;78(5):285–297.
   PubMed Web of Science ®Google Scholar
• Gore FM, Bloem PJ, Patton GC, et al. Global burden of disease in young people aged 10–24 years: a systematic analysis. Lancet. 2011;377(9783):2093–2102.
   PubMed Web of Science ®Google Scholar
• Kapczinski NS, Narvaez JC, Magalhaes PV, et al. Cognition and functioning in bipolar depression. Rev Bras Psiquiatr. 2016;38(3):201–206.
   PubMed Web of Science ®Google Scholar
• Rosa AR, Reinares M, Michalak EE, et al. Functional impairment and disability across mood states in bipolar disorder. Value Health. 2010;13(8):984–988.
   PubMed Web of Science ®Google Scholar
• Samalin L, Boyer L, Murru A, et al. Residual depressive symptoms, sleep disturbance and perceived cognitive impairment as determinants of functioning in patients with bipolar disorder. J Affect Disord. 2017;210:280–286.
   PubMed Web of Science ®Google Scholar
• Simon GE, Bauer MS, Ludman EJ, et al. Mood symptoms, functional impairment, and disability in people with bipolar disorder: specific effects of mania and depression. J Clin Psychiatry. 2007;68(08):1237–1245.
   PubMed Web of Science ®Google Scholar
• Simon GE, Ludman EJ, Unutzer J, et al. Severity of mood symptoms and work productivity in people treated for bipolar disorder. Bipolar Disord. 2008;10(6):718–725.
   PubMed Web of Science ®Google Scholar
• Goldberg JF, Harrow M. Subjective life satisfaction and objective functional outcome in bipolar and unipolar mood disorders: a longitudinal analysis. J Affect Disord. 2005;89(1–3):79–89.
   PubMed Web of Science ®Google Scholar
• Judd LL, Schettler PJ, Solomon DA, et al. Psychosocial disability and work role function compared across the long-term course of bipolar I, bipolar II and unipolar major depressive disorders. J Affect Disord. 2008;108(1–2):49–58.
   PubMed Web of Science ®Google Scholar
• Shippee ND, Shah ND, Williams MD, et al. Differences in demographic composition and in work, social, and functional limitations among the populations with unipolar depression and bipolar disorder: results from a nationally representative sample. Health Qual Life Outcomes. 2011;9:90.
   PubMed Web of Science ®Google Scholar
• van der Voort TY, Seldenrijk A, van Meijel B, et al. Functional versus syndromal recovery in patients with major depressive disorder and bipolar disorder. J Clin Psychiatry. 2015;76(6):e809-14.
   PubMed Web of Science ®Google Scholar
• Martinez-Aran A, Vieta E, Colom F, et al. Cognitive impairment in euthymic bipolar patients: implications for clinical and functional outcome. Bipolar Disord. 2004;6(3):224–232.
   PubMed Web of Science ®Google Scholar
• Martinez-Aran A, Vieta E, Torrent C, et al. Functional outcome in bipolar disorder: the role of clinical and cognitive factors. Bipolar Disord. 2007;9(1–2):103–113.
   PubMed Web of Science ®Google Scholar
• Serafini G, Canepa G, Adavastro G, et al. The relationship between childhood maltreatment and non-suicidal self-injury: a systematic review. Front Psychiatry. 2017;8:149.
   PubMed Web of Science ®Google Scholar
• Wingo AP, Baldessarini RJ, Holtzheimer PE, et al. Factors associated with functional recovery in bipolar disorder patients. Bipolar Disord. 2010;12(3):319–326.
   PubMed Web of Science ®Google Scholar
• Chen M, Fitzgerald HM, Madera JJ, et al. Functional outcome assessment in bipolar disorder: a systematic literature review. Bipolar Disord. 2019;21(3):194–214.
   PubMed Web of Science ®Google Scholar
• Durgam S, Earley W, Lipschitz A, et al. An 8-week randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of cariprazine in patients with bipolar I depression. Am J Psychiatry. 2016;173(3):271–281.
   PubMed Web of Science ®Google Scholar
• Earley W, Burgess MV, Rekeda L, et al. Cariprazine treatment of bipolar depression: a randomized double-blind placebo-controlled phase 3 study. Am J Psychiatry. 2019;176(6):439–448.
   PubMed Web of Science ®Google Scholar
• Earley WR, Burgess MV, Khan B, et al. Efficacy and safety of cariprazine in bipolar I depression: a double-blind, placebo-controlled phase 3 study. Bipolar Disord. 2020;22(4):372–384.
   PubMed Web of Science ®Google Scholar
• Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979;134:382–389.
   PubMed Web of Science ®Google Scholar
• American Psychiatric Association (APA). 2000. Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision. Washington DC: American Psychiatric Association.
   Google Scholar
• Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960;23:56–62.
   PubMed Web of Science ®Google Scholar
• Guy W. The Clinical Global Impression Severity and Improvement Scales. ECDEU assessment manual for psychopharmacology. Rockville (MD): National Institute of Mental Health, US Department of Health, Education and Welfare publication (ADM); 1976. p. 218–222.
   Google Scholar
• Young RC, Biggs JT, Ziegler VE, et al. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry. 1978;133:429–435.
   PubMed Web of Science ®Google Scholar
• Althouse AD. Adjust for multiple comparisons? It's not that simple. Ann Thorac Surg. 2016;101(5):1644–1645.
   PubMed Web of Science ®Google Scholar
• Bonnin CM, Martinez-Aran A, Reinares M, et al. Thresholds for severity, remission and recovery using the functioning assessment short test (FAST) in bipolar disorder. J Affect Disord. 2018;240:57–62.
   PubMed Web of Science ®Google Scholar
• Beyer JL. An evidence-based medicine strategy for achieving remission in bipolar disorder. J Clin Psychiatry. 2008;69(Suppl 3):31–37.
   PubMed Web of Science ®Google Scholar
• Muller MJ, Szegedi A, Wetzel H, et al. Moderate and severe depression. Gradations for the Montgomery-Asberg Depression Rating Scale. J Affect Disord. 2000;60(2):137–140.
   PubMed Web of Science ®Google Scholar
• Sanchez-Moreno J, Martinez-Aran A, Vieta E. Treatment of functional impairment in patients with bipolar disorder. Curr Psychiatry Rep. 2017;19(1):3.
   PubMed Web of Science ®Google Scholar
• Sole B, Bonnin CM, Jimenez E, et al. Heterogeneity of functional outcomes in patients with bipolar disorder: a cluster-analytic approach. Acta Psychiatr Scand. 2018;137(6):516–527.
   PubMed Web of Science ®Google Scholar
• Jaeger J, Berns S, Loftus S, et al. Neurocognitive test performance predicts functional recovery from acute exacerbation leading to hospitalization in bipolar disorder. Bipolar Disord. 2007;9(1–2):93–102.
   PubMed Web of Science ®Google Scholar
• Tohen M, Frank E, Bowden CL, et al. The International Society for Bipolar Disorders (ISBD) Task Force report on the nomenclature of course and outcome in bipolar disorders. Bipolar Disord. 2009;11(5):453–473.
   PubMed Web of Science ®Google Scholar
• Harvey PD. Defining and achieving recovery from bipolar disorder. J Clin Psychiatry. 2006;67(Suppl 9):14–18.
   PubMedGoogle Scholar
• Vieta E, Torrent C. Functional remediation: the pathway from remission to recovery in bipolar disorder. World Psychiatry. 2016;15(3):288–289.
   PubMed Web of Science ®Google Scholar
• Berk M, Ng F, Wang WV, et al. The empirical redefinition of the psychometric criteria for remission in bipolar disorder. J Affect Disord. 2008;106(1–2):153–158.
   PubMed Web of Science ®Google Scholar
• Ketter TA, Miller S, Dell'Osso B, et al. Balancing benefits and harms of treatments for acute bipolar depression. J Affect Disord. 2014;169(Suppl 1):S24–S33.
   PubMed Web of Science ®Google Scholar
• Citrome L. Cariprazine for the treatment of schizophrenia: A review of this dopamine d3-preferring d3/d2 receptor partial agonist. Clin Schizophr Relat Psychoses. 2016;10(2):109–119.
   PubMedGoogle Scholar
• Girgis RR, Slifstein M, D'Souza D, et al. Preferential binding to dopamine D3 over D2 receptors by cariprazine in patients with schizophrenia using PET with the D3/D2 receptor ligand [(11)C]–(+)–PHNO. Psychopharmacology. 2016;233(19–20):3503–3512.
   PubMed Web of Science ®Google Scholar
• Earley WR, Burgess M, Rekeda L, et al. A pooled post hoc analysis evaluating the safety and tolerability of cariprazine in bipolar depression. J Affect Disord. 2020;263:386–395.
   PubMed Web of Science ®Google Scholar