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Treatment of bipolar depression: making sensible decisions

Published online by Cambridge University Press:  19 November 2014

Leslie Citrome
Leslie Citrome*
Affiliation:
Department of Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, New York, USA
*
*Address for correspondence: Leslie Citrome, MD, MPH, 11 Medical Park Drive, Suite 106, Pomona, NY 10970, USA. (Email: [email protected])
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Abstract

A major challenge in the treatment of major depressive episodes associated with bipolar disorder is differentiating this illness from major depressive episodes associated with major depressive disorder. Mistaking the former for the latter will lead to incorrect treatment and poor outcomes. None of the classic antidepressants, serotonin specific reuptake inhibitors, or serotonin-norepinephrine reuptake inhibitors have ever received regulatory approval as monotherapies for the treatment of bipolar depression. At present, there are only 3 approved medication treatments for bipolar depression: olanzapine/fluoxetine combination, quetiapine (immediate or extended release), and lurasidone (monotherapy or adjunctive to lithium or valproate). All 3 have similar efficacy profiles, but they differ in terms of tolerability. Number needed to treat (NNT) and number needed to harm (NNH) can be used to quantify these similarities and differences. The NNTs for response and remission for each of these interventions vs placebo range from 4 to 7, and 5 to 7, respectively, with overlap in terms of their 95% confidence intervals. NNH values less than 10 (vs placebo) were observed for the spontaneously reported adverse events of weight gain and diarrhea for olanzapine/fluoxetine combination (7 and 9, respectively) and somnolence and dry mouth for quetiapine (3 and 4, respectively). There were no NNH values less than 10 (vs placebo) observed with lurasidone treatment. NNH values vs placebo for weight gain of at least 7% from baseline were 6, 16, 58, and 36, for olanzapine/fluoxetine combination, quetiapine, lurasidone monotherapy, and lurasidone combined with lithium or valproate, respectively. Individualizing treatment decisions will require consideration of the different potential adverse events that are more likely to occur with each medication. The metric of the likelihood to be helped or harmed (LHH) is the ratio of NNH to NNT and can illustrate the tradeoffs inherent in selecting medications. A more favorable LHH was noted for treatment with lurasidone. However, OFC and quetiapine monotherapy may still have utility in high urgency situations, particularly in persons who have demonstrated good outcomes with these interventions in the past, and where a pressing clinical need for efficacy mitigates their potential tolerability shortcomings. In terms of maintenance therapy, adjunctive quetiapine is the only agent where the NNT vs lithium or valproate alone is less than 10 for both the prevention of mania and the prevention of depression.

Keywords

Antidepressantsbipolar depressionbipolar disorderlikelihood to be helped or harmedlithiumlurasidonemajor depressive disordernumber needed to harmnumber need to treatolanzapine/fluoxetine combinationquetiapinevalproate
Type
CME Review Article
Information
CNS Spectrums , Volume 19 , Issue S1: CME SUPPLEMENT , December 2014 , pp. 1 - 12
Copyright
© Cambridge University Press 2014 

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Footnotes

This activity is supported by an educational grant from Sunovion Pharmaceuticals Inc.

References

1.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.CrossRefGoogle ScholarPubMed
2.Judd, LL, Akiskal, HS, Schettler, PJ, et al. The long-term natural history of the weekly symptomatic status of bipolar disorder. Arch Gen Psychiatry. 2002; 59(6): 530–537.CrossRefGoogle Scholar
3.Judd, LL, Akiskal, HS, Schettler, PJ, et al. A prospective investigation of the natural history of the long-term weekly symptomatic status of bipolar II disorder. Arch Gen Psychiatry. 2003; 60(3): 261–269.CrossRefGoogle ScholarPubMed
4.Citrome, L, Ketter, TA, Cucchiaro, J, Loebel, A. Clinical assessment of lurasidone benefit and risk in the treatment of bipolar I depression using number needed to treat, number needed to harm, and likelihood to be helped or harmed. J Affect Disord. 2014; 155: 20–27.CrossRefGoogle ScholarPubMed
5.American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders., 5th ed.Arlington, VA: American Psychiatric Publishing; 2013.Google Scholar
6.Berk, M, Berk, L, Moss, K, Dodd, S, Malhi, GS. Diagnosing bipolar disorder: how can we do it better? Med J Aust. 2006; 184(9): 459–462.CrossRefGoogle Scholar
7.Hirschfeld, RM, Williams, JB, Spitzer, RL, et al. Development and validation of a screening instrument for bipolar spectrum disorder: the Mood Disorder Questionnaire. Am J Psychiatry. 2000; 157(11): 1873–1875.CrossRefGoogle ScholarPubMed
8.Hirschfeld, RM, Lewis, L, Vornik, LA. Perceptions and impact of bipolar disorder: how far have we really come? Results of the National Depressive and Manic-Depressive Association 2000 survey of individuals with bipolar disorder. J Clin Psychiatry. 2003; 64(2): 161–174.CrossRefGoogle ScholarPubMed
9.Simon, NM, Otto, MW, Weiss, RD, et al. STEP-BD Investigators. Pharmacotherapy for bipolar disorder and comorbid conditions: baseline data from STEP-BD. J Clin Psychopharmacol. 2004; 24(5): 512–520.CrossRefGoogle ScholarPubMed
10.Goldstein, BI, Fagiolini, A, Houck, P, Kupfer, DJ. Cardiovascular disease and hypertension among adults with bipolar I disorder in the United States. Bipolar Disord. 2009; 11(6): 657–662.CrossRefGoogle ScholarPubMed
11.Vornik, LA, Hirschfeld, RM. Bipolar disorder: quality of life and the impact of atypical antipsychotics. Am J Manag Care. 2005; 11(9 Suppl): S275–S280.Google ScholarPubMed
12.de Almeida, KM, Moreira, CL, Lafer, B. Metabolic syndrome and bipolar disorder: what should psychiatrists know? CNS Neurosci Ther. 2012; 18(2): 160–166.CrossRefGoogle ScholarPubMed
13.Hirschfeld, RM, Cass, AR, Holt, DC, Carlson, CA. Screening for bipolar disorder in patients treated for depression in a family medicine clinic. J Am Board Fam Pract. 2005; 18(4): 233–239.CrossRefGoogle Scholar
14.Das, AK, Olfson, M, Gameroff, MJ, et al. Screening for bipolar disorder in a primary care practice. JAMA. 2005; 293(8): 956–963.CrossRefGoogle Scholar
15.Pacchiarotti, I, Bond, DJ, Baldessarini, RJ, et al. The International Society for Bipolar Disorders (SBD) task force report on antidepressant use in bipolar disorders. Am J Psychiatry. 2013; 170(11): 1249–1262.CrossRefGoogle Scholar
16.Sachs, GS, Nierenberg, AA, Calabrese, JR, et al. Effectiveness of adjunctive antidepressant treatment for bipolar depression. N Engl J Med. 2007; 356(17): 1711–1722.CrossRefGoogle ScholarPubMed
17.Muzina, DJ, Colangelo, E, Manning, JS, Calabrese, JR. Differentiating bipolar disorder from depression in primary care. Cleve Clin J Med. 2007; 74(2): 89–105.CrossRefGoogle ScholarPubMed
18.Manning, JS. Tools to improve differential diagnosis of bipolar disorder in primary care. Prim Care Companion. 2010; 12(Suppl 1): 17–22.Google ScholarPubMed
19.Bowden, CL. Strategies to reduce misdiagnosis of bipolar depression. Psychiatr Serv. 2001; 52(1): 51–55.CrossRefGoogle ScholarPubMed
20.Citrome, L, Goldberg, JF. The many faces of bipolar disorder How to tell them apart. Postgrad Med. 2005; 117(2): 15–16, 19–23.Google ScholarPubMed
21.Montgomery, SA, Asberg, M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979; 134(4): 382–389.CrossRefGoogle ScholarPubMed
22.Citrome, L. Compelling or irrelevant? Using number needed to treat can help decide. Acta Psychiatr Scand. 2008; 117(6): 412–419.CrossRefGoogle ScholarPubMed
23.Citrome, L. Relative vs. absolute measures of benefit and risk: what’s the difference? Acta Psychiatr Scand. 2010; 121(2): 94–102.CrossRefGoogle ScholarPubMed
24.Citrome, L, Ketter, TA. When does a difference make a difference? Interpretation of number needed to treat, number needed to harm, and likelihood to be helped or harmed. Int J Clin Pract. 2013; 67(5): 407–411.CrossRefGoogle ScholarPubMed
25.Loebel, A, Cucchiaro, J, Silva, R, et al. Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014; 171(2): 160–168.CrossRefGoogle ScholarPubMed
26.Loebel, A, Cucchiaro, J, Silva, R, et al. Lurasidone as adjunctive therapy with lithium or valproate for the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry. 2014; 171(2): 169–177.CrossRefGoogle ScholarPubMed
27.Calabrese, JR, Keck, PE Jr, Macfadden, W, et al. A randomized, double-blind, placebo-controlled trial of quetiapine in the treatment of bipolar I or II depression. Am J Psychiatry. 2005; 162(7): 1351–1360.CrossRefGoogle ScholarPubMed
28.Thase, ME, Macfadden, W, Weisler, RH, Chang, W, Paulsson, B, Khan, A, Calabrese, JR. BOLDER II Study Group. Efficacy of quetiapine monotherapy in bipolar I and II depression: a double-blind, placebo-controlled study (the BOLDER II study). J Clin Psychopharmacol. 2006; 26(6): 600–609.CrossRefGoogle Scholar
29.Suppes, T, Datto, C, Minkwitz, M, Nordenhem, A, Walker, C, Darko, D. Effectiveness of the extended release formulation of quetiapine as monotherapy for the treatment of acute bipolar depression. J Affect Disord. 2010; 121(1–2): 106–115.CrossRefGoogle ScholarPubMed
30.Citrome, L. Olanzapine-fluoxetine combination for the treatment of bipolar depression. Expert Opin Pharmacother. 2011; 12(17): 2751–2758.CrossRefGoogle ScholarPubMed
31.Tohen, M, Vieta, E, Calabrese, , et al. Efficacy of olanzapine and olanzapine-fluoxetine combination in the treatment of bipolar I depression. Arch Gen Psychiatry. 2003; 60(11): 1079–1088.CrossRefGoogle ScholarPubMed
32.Sunovion. Latuda (lurasidone). Revised July 2013. http://www.latuda.com/LatudaPrescribingInformation.pdf. Accessed July 2, 2014.Google Scholar
33.AstraZeneca. Seroquel (quetiapine fumarate). Revised October 2013. http://www1.astrazeneca-us.com/pi/Seroquel.pdf. Accessed July 2, 2014.Google Scholar
34.AstraZeneca. Seroquel XR (quetiapine fumarate extended release). Revised October 2013. http://www1.astrazeneca-us.com/pi/seroquelxr.pdf. Accessed July 2, 2014.Google Scholar
35.Sidor, MM, Macqueen, GM. Antidepressants for the acute treatment of bipolar depression: a systematic review and meta-analysis. J Clin Psychiatry. 2011; 72(2): 156–167.CrossRefGoogle ScholarPubMed
36.Thase, ME, Jonas, A, Khan, A, et al. Aripiprazole monotherapy in nonpsychotic bipolar I depression: results of 2 randomized, placebo-controlled studies. J Clin Psychopharmacol. 2008; 28(1): 13–20.CrossRefGoogle ScholarPubMed
37.Sachs, GS, Ice, KS, Chappell, PB, et al. Efficacy and safety of adjunctive oral ziprasidone for acute treatment of depression in patients with bipolar I disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2011; 72(10): 1413–1422.CrossRefGoogle ScholarPubMed
38.Lombardo, I, Sachs, G, Kolluri, S, Kremer, C, Yang, R. Two 6-week, randomized, double-blind, placebo-controlled studies of ziprasidone in outpatients with bipolar I depression: did baseline characteristics impact trial outcome? J Clin Psychopharmacol. 2012; 32(4): 470–478.CrossRefGoogle ScholarPubMed
39.Ketter, TA, Citrome, L, Wang, PW, Culver, JL, Srivastava, S. Treatments for bipolar disorder: can number needed to treat/harm help inform clinical decisions? Acta Psychiatr Scand. 2011; 123(3): 175–189.CrossRefGoogle ScholarPubMed
40.Popovic, D, Reinares, M, Goikolea, JM, Bonnin, CM, Gonzalez-Pinto, A, Vieta, E. Polarity index of pharmacological agents used for maintenance treatment of bipolar disorder. Eur Neuropsychopharmacol. 2012; 22(5): 339–346.CrossRefGoogle ScholarPubMed
41.Calabrese, JR, Vieta, E, El-Mallakh, R, et al. Mood state at study entry as predictor of the polarity of relapse in bipolar disorder. Biol Psychiatry. 2004; 56(12): 957–963.CrossRefGoogle ScholarPubMed
42.Popovic, D, Reinares, M, Scott, J, et al. Polarity index of psychological interventions in maintenance treatment of bipolar disorder. Psychother Psychosom. 2013; 82(5): 292–298.CrossRefGoogle ScholarPubMed
43.Lam, DH, Watkins, ER, Hayward, P, et al. A randomized controlled study of cognitive therapy for relapse prevention for bipolar affective disorder: outcome of the first year. Arch Gen Psychiatry. 2003; 60(2): 145–152.CrossRefGoogle ScholarPubMed
44.Perry, A, Tarrier, N, Morriss, R, McCarthy, E, Limb, K. Randomised controlled trial of efficacy of teaching patients with bipolar disorder to identify early symptoms of relapse and obtain treatment. BMJ. 1999; 318(7177): 149–153.CrossRefGoogle ScholarPubMed