55 - References
References
322 The Maudsley® Prescribing Guidelines in Psychiatry CHAPTER 2 Summary of drug choice The combination of olanzapine + fluoxetine is probably the most effective treatment available for bipolar depression but its use is constrained by the well-known adverse effect profile of olanzapine. SSRIs other than fluoxetine may be effective but should probably be avoided unless clear individual benefit is obvious.54 Alternative first-line choices are quetiapine, olanzapine, lurasidone, lamotrigine and cariprazine (and lumateperone in North America). These drugs differ substantially in adverse effect profile, tolerability and cost, each of which needs to be considered when prescribing for an individual. Lithium is also effective but supporting evidence is relatively weak. Second-line drugs include ketamine and, increasingly, modafinil. Aripiprazole, risperidone, ziprasidone, tricyclics (with the exception of imipramine) and MAOIs (with the exception of tranylcypromine) are probably not effective and should not be used routinely.114 References
- Malhi GS, et al. Bipolar depression: management options. CNS Drugs 2003; 17:9–25.
- Perlis RH, et al. Clinical features of bipolar depression versus major depressive disorder in large multicenter trials. Am J Psychiatry 2006; 163:225–231.
- Mitchell PB, et al. Comparison of depressive episodes in bipolar disorder and in major depressive disorder within bipolar disorder pedigrees. Br J Psychiatry 2011; 199:303–309.
- Haddad P, et al. Pharmacological management of bipolar depression. Acta Psychiatr Scand 2002; 105:401–403.
- Hirschfeld RM. Bipolar depression: the real challenge. Eur Neuropsychopharmacol 2004; 14 Suppl 2:S83–S88.
- Judd LL, et al. The long-term natural history of the weekly symptomatic status of bipolar I disorder. Arch Gen Psychiatry 2002; 59:530–537.
- Judd LL, et al. A prospective investigation of the natural history of the long-term weekly symptomatic status of bipolar II disorder. Arch Gen Psychiatry 2003; 60:261–269.
- National Institute for Health and Care Excellence. Bipolar disorder: assessment and management. Clinical guideline [CG185]. 2014 (last updated December 2023, last accessed October 2024); https://www.nice.org.uk/guidance/cg185. Table 2.11 Other possible treatments (seek specialist advice before using). Drug/regimen Comments Aripiprazole99–102 Limited support from open studies as add-on treatment. One RCT was negative. Possibly not effective.98 Carbamazepine1,17,103 Occasionally recommended but database is poor and effect modest. May have useful activity when added to other mood stabilisers. Gabapentin1,104,105 Open studies suggest modest effect when added to mood stabilisers or antipsychotics. Doses average around 1750mg/day. Anxiolytic effect may account for apparent effect in bipolar depression. Inositol106 Small, randomised, pilot study suggests that 12g/day inositol is effective in bipolar depression. Mifepristone107,108 Some evidence of mood-elevating properties in bipolar depression although this was not replicated in a larger trial. Improved cognitive function in both trials. Dose used was 600mg/day. Modafinil109 Meta-analysis of five studies of modafinil/armodafinil suggests robust benefit on response and remission with good tolerability and no evidence of increased risk of switching. Some evidence of safety from a later study.110 Omega-3 fatty acids111–113 One positive RCT (1g/2g a day) and one negative (6g a day). The ratio of omega-6 may determine efficacy.113 RCT, randomised controlled trial.
Bipolar disorder CHAPTER 2 9. Goodwin GM, et al. Evidence-based guidelines for treating bipolar disorder: revised third edition recommendations from the British Association for Psychopharmacology. J Psychopharmacol 2016; 30:495–553. 10. Malhi GS, et al. The 2020 Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for mood disorders. Aust NZ J Psychiatry 2021; 55:7–117. 11. Keramatian K, et al. The CANMAT and ISBD guidelines for the treatment of bipolar disorder: summary and a 2023 update of evidence. Focus (Am Psychiatr Publ) 2023; 21:344–353. 12. Kadakia A, et al. Efficacy and tolerability of atypical antipsychotics for acute bipolar depression: a network meta-analysis. BMC Psychiatry 2021; 21:249. 13. Li S, et al. Efficacy and tolerability of FDA-approved atypical antipsychotics for the treatment of bipolar depression: a systematic review and network meta-analysis. Eur Psychiatry 2024; 67:e29. 14. Yildiz A, et al. Comparative efficacy and tolerability of pharmacological interventions for acute bipolar depression in adults: a systematic review and network meta-analysis. Lancet Psychiatry 2023; 10:693–705. 15. Zhan Z, et al. Comparative efficacy and side-effect profile of ketamine and esketamine in the treatment of unipolar and bipolar depression: protocol for a systematic review and network meta-analysis. BMJ Open 2021; 11:e043457. 16. Rodolico A, et al. Efficacy and safety of ketamine and esketamine for unipolar and bipolar depression: an overview of systematic reviews with meta-analysis. Front Psychiatry 2024; 15:1325399. 17. Yatham LN, et al. Bipolar depression: criteria for treatment selection, definition of refractoriness, and treatment options. Bipolar Disord 2003; 5:85–97. 18. Calabrese JR, et al. A double-blind placebo-controlled study of lamotrigine monotherapy in outpatients with bipolar I depression. Lamictal 602 Study Group. J Clin Psychiatry 1999; 60:79–88. 19. Bowden CL, et al. Lamotrigine in the treatment of bipolar depression. Eur Neuropsychopharmacol 1999; 9 Suppl 4:S113–S117. 20. Marangell LB, et al. Lamotrigine treatment of bipolar disorder: data from the first 500 patients in STEP-BD. Bipolar Disord 2004; 6:139–143. 21. Schaffer A, et al. Randomized, double-blind pilot trial comparing lamotrigine versus citalopram for the treatment of bipolar depression. J Affect Disord 2006; 96:95–99. 22. Calabrese JR, et al. Lamotrigine in the acute treatment of bipolar depression: results of five double-blind, placebo-controlled clinical trials. Bipolar Disord 2008; 10:323–333. 23. Van der Loos ML, et al. Efficacy and safety of lamotrigine as add-on treatment to lithium in bipolar depression: a multicenter, double-blind, placebo-controlled trial. J Clin Psychiatry 2009; 70:223–231. 24. Newport DJ, et al. Lamotrigine in bipolar disorder: efficacy during pregnancy. Bipolar Disord 2008; 10:432–436. 25. Geddes JR, et al. Comparative evaluation of quetiapine plus lamotrigine combination versus quetiapine monotherapy (and folic acid versus placebo) in bipolar depression (CEQUEL): a 2 x 2 factorial randomised trial. Lancet Psychiatry 2016; 3:31–39. 26. Goodwin GM, et al. A pooled analysis of 2 placebo-controlled 18-month trials of lamotrigine and lithium maintenance in bipolar I disorder. J Clin Psychiatry 2004; 65:432–441. 27. Geddes JR, et al. Long-term lithium therapy for bipolar disorder: systematic review and meta-analysis of randomized controlled trials. Am J Psychiatry 2004; 161:217–222. 28. Calabrese JR, et al. A placebo-controlled 18-month trial of lamotrigine and lithium maintenance treatment in recently depressed patients with bipolar I disorder. J Clin Psychiatry 2003; 64:1013–1024. 29. Prien RF, et al. Lithium carbonate and imipramine in prevention of affective episodes. A comparison in recurrent affective illness. Arch Gen Psychiatry 1973; 29:420–425. 30. Grunze H, et al. The World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the biological treatment of bipolar disorders: update 2010 on the treatment of acute bipolar depression. World J Biol Psychiatry 2010; 11:81–109. 31. Goodwin FK, et al. Suicide risk in bipolar disorder during treatment with lithium and divalproex. JAMA 2003; 290:1467–1473. 32. Kessing LV, et al. Suicide risk in patients treated with lithium. Arch Gen Psychiatry 2005; 62:860–866. 33. Loebel A, et al. Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry 2014; 171:160–168. 34. Loebel A, 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; 171:169–177. 35. Suppes T, et al. Lurasidone adjunctive with lithium or valproate for bipolar depression: a placebo-controlled trial utilizing prospective and retrospective enrolment cohorts. J Psychiatr Res 2016; 78:86–93. 36. Suppes T, et al. Lurasidone for the treatment of major depressive disorder with mixed features: a randomized, double-blind, placebo- controlled study. Am J Psychiatry 2016; 173:400–407. 37. Chapel S, et al. Lurasidone dose response in bipolar depression: a population dose-response analysis. Clin Ther 2016; 38:4–15. 38. Ostacher M, et al. Lurasidone compared to other atypical antipsychotic monotherapies for bipolar depression: a systematic review and network meta-analysis. World J Biol Psychiatry 2018; 19:586–601. 39. Calabrese JR, et al. International Consensus Group on Bipolar I Depression Treatment Guidelines. J Clin Psychiatry 2004; 65:571–579. 40. Nemeroff CB, et al. Double-blind, placebo-controlled comparison of imipramine and paroxetine in the treatment of bipolar depression. Am J Psychiatry 2001; 158:906–912. 41. Vieta E, et al. A randomized trial comparing paroxetine and venlafaxine in the treatment of bipolar depressed patients taking mood stabilizers. J Clin Psychiatry 2002; 63:508–512. 42. Young LT, et al. Double-blind comparison of addition of a second mood stabilizer versus an antidepressant to an initial mood stabilizer for treatment of patients with bipolar depression. Am J Psychiatry 2000; 157:124–126. 43. Fawcett JA. Lithium combinations in acute and maintenance treatment of unipolar and bipolar depression. J Clin Psychiatry 2003; 64 Suppl 5:32–37.
324 The Maudsley® Prescribing Guidelines in Psychiatry CHAPTER 2 44. Altshuler L, et al. The impact of antidepressant discontinuation versus antidepressant continuation on 1-year risk for relapse of bipolar depression: a retrospective chart review. J Clin Psychiatry 2001; 62:612–616. 45. Erfurth A, et al. Bupropion as add-on strategy in difficult-to-treat bipolar depressive patients. Neuropsychobiology 2002; 45 Suppl 1:33–36. 46. Sachs GS, et al. Effectiveness of adjunctive antidepressant treatment for bipolar depression. N Engl J Med 2007; 356:1711–1722. 47. Goldberg JF, et al. Adjunctive antidepressant use and symptomatic recovery among bipolar depressed patients with concomitant manic symptoms: findings from the STEP-BD. Am J Psychiatry 2007; 164:1348–1355. 48. Tada M, et al. Antidepressant dose and treatment response in bipolar depression: reanalysis of the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) data. J Psychiatr Res 2015; 68:151–156. 49. Post RM, et al. Mood switch in bipolar depression: comparison of adjunctive venlafaxine, bupropion and sertraline. Br J Psychiatry 2006; 189:124–131. 50. Leverich GS, et al. Risk of switch in mood polarity to hypomania or mania in patients with bipolar depression during acute and continuation trials of venlafaxine, sertraline, and bupropion as adjuncts to mood stabilizers. Am J Psychiatry 2006; 163:232–239. 51. Salvi V, et al. The use of antidepressants in bipolar disorder. J Clin Psychiatry 2008; 69:1307–1318. 52. Altshuler LL, et al. Impact of antidepressant continuation after acute positive or partial treatment response for bipolar depression: a blinded, randomized study. J Clin Psychiatry 2009; 70:450–457. 53. Ghaemi SN, et al. Long-term antidepressant treatment in bipolar disorder: meta-analyses of benefits and risks. Acta Psychiatr Scand 2008; 118:347–356. 54. Pacchiarotti I, et al. The International Society for Bipolar Disorders (ISBD) task force report on antidepressant use in bipolar disorders. Am J Psychiatry 2013; 170:1249–1262. 55. Altshuler LL, et al. Switch rates during acute treatment for bipolar II depression with lithium, sertraline, or the two combined: a randomized double-blind comparison. Am J Psychiatry 2017; 174:266–276. 56. Yatham LN, et al. Duration of adjunctive antidepressant maintenance in bipolar I depression. N Engl J Med 2023; 389:430–440. 57. Yatham LN, et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder. Bipolar Disord 2018; 20:97–170. 58. Tohen M, et al. Efficacy of olanzapine and olanzapine-fluoxetine combination in the treatment of bipolar I depression. Arch Gen Psychiatry 2003; 60:1079–1088. 59. Brown EB, et al. A 7-week, randomized, double-blind trial of olanzapine/fluoxetine combination versus lamotrigine in the treatment of bipolar I depression. J Clin Psychiatry 2006; 67:1025–1033. 60. Corya SA, et al. A 24-week open-label extension study of olanzapine-fluoxetine combination and olanzapine monotherapy in the treatment of bipolar depression. J Clin Psychiatry 2006; 67:798–806. 61. Dube S, et al. Onset of antidepressant effect of olanzapine and olanzapine/fluoxetine combination in bipolar depression. Bipolar Disord 2007; 9:618–627. 62. Tohen M, et al. Randomised, double-blind, placebo-controlled study of olanzapine in patients with bipolar I depression. Br J Psychiatry 2012; 201:376–382. 63. Calabrese JR, et al. A randomized, double-blind, placebo-controlled trial of quetiapine in the treatment of bipolar I or II depression. Am J Psychiatry 2005; 162:1351–1360. 64. Thase ME, et al. Efficacy of quetiapine monotherapy in bipolar I and II depression: a double-blind, placebo-controlled study (the BOLDER II study). J Clin Psychopharmacol 2006; 26:600–609. 65. Suppes T, et al. Effectiveness of the extended release formulation of quetiapine as monotherapy for the treatment of acute bipolar depression. J Affect Disord 2010; 121:106–115. 66. Young AH, et al. A double-blind, placebo-controlled study of quetiapine and lithium monotherapy in adults in the acute phase of bipolar depression (EMBOLDEN I). J Clin Psychiatry 2010; 71:150–162. 67. McElroy SL, et al. A double-blind, placebo-controlled study of quetiapine and paroxetine as monotherapy in adults with bipolar depression (EMBOLDEN II). J Clin Psychiatry 2010; 71:163–174. 68. Li H, et al. Efficacy and safety of quetiapine extended release monotherapy in bipolar depression: a multi-center, randomized, double-blind, placebo-controlled trial. Psychopharmacology (Berl) 2016; 233:1289–1297. 69. Vieta E, et al. Efficacy and safety of quetiapine in combination with lithium or divalproex for maintenance of patients with bipolar I disorder (international trial 126). J Affect Disord 2008; 109:251–263. 70. Suppes T, et al. Maintenance treatment for patients with bipolar I disorder: results from a North American study of quetiapine in combination with lithium or divalproex (trial 127). Am J Psychiatry 2009; 166:476–488. 71. Goodwin GM. Evidence-based guidelines for treating bipolar disorder: revised second edition – recommendations from the British Association for Psychopharmacology. J Psychopharmacol 2009; 23:346–388. 72. Davis LL, et al. Divalproex in the treatment of bipolar depression: a placebo-controlled study. J Affect Disord 2005; 85:259–266. 73. Ghaemi SN, et al. Divalproex in the treatment of acute bipolar depression: a preliminary double-blind, randomized, placebo-controlled pilot study. J Clin Psychiatry 2007; 68:1840–1844. 74. Smith LA, et al. Valproate for the treatment of acute bipolar depression: systematic review and meta-analysis. J Affect Disord 2010; 122:1–9. 75. Muzina DJ, et al. Acute efficacy of divalproex sodium versus placebo in mood stabilizer-naive bipolar I or II depression: a double-blind, randomized, placebo-controlled trial. J Clin Psychiatry 2011; 72:813–819. 76. Amsterdam JD, et al. Short-term fluoxetine monotherapy for bipolar type II or bipolar NOS major depression – low manic switch rate. Bipolar Disord 2004; 6:75–81. 77. Amsterdam JD, et al. Efficacy and safety of fluoxetine in treating bipolar II major depressive episode. J Clin Psychopharmacol 1998; 18:435–440.
Bipolar disorder CHAPTER 2 78. Amsterdam J. Efficacy and safety of venlafaxine in the treatment of bipolar II major depressive episode. J Clin Psychopharmacol 1998; 18:414–417. 79. Amsterdam JD, et al. Venlafaxine monotherapy in women with bipolar II and unipolar major depression. J Affect Disord 2000; 59:225–229. 80. Silverstone T. Moclobemide vs. imipramine in bipolar depression: a multicentre double-blind clinical trial. Acta Psychiatr Scand 2001; 104:104–109. 81. Ghaemi SN, et al. Antidepressant treatment in bipolar versus unipolar depression. Am J Psychiatry 2004; 161:163–165. 82. Post RM, et al. A re-evaluation of the role of antidepressants in the treatment of bipolar depression: data from the Stanley Foundation Bipolar Network. Bipolar Disord 2003; 5:396–406. 83. Amsterdam JD, et al. Comparison of fluoxetine, olanzapine, and combined fluoxetine plus olanzapine initial therapy of bipolar type I and type II major depression – lack of manic induction. J Affect Disord 2005; 87:121–130. 84. Amsterdam JD, et al. Fluoxetine monotherapy of bipolar type II and bipolar NOS major depression: a double-blind, placebo-substitution, continuation study. Int Clin Psychopharmacol 2005; 20:257–264. 85. Heijnen WT, et al. Efficacy of tranylcypromine in bipolar depression: a systematic review. J Clin Psychopharmacol 2015; 35:700–705. 86. Durgam S, 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; 173:271–281. 87. Earley W, et al. Cariprazine treatment of bipolar depression: a randomized double-blind placebo-controlled phase 3 study. Am J Psychiatry 2019; 176:439–448. 88. Diazgranados N, et al. A randomized add-on trial of an N-methyl-D-aspartate antagonist in treatment-resistant bipolar depression. Arch Gen Psychiatry 2010; 67:793–802. 89. Shahani R, et al. Ketamine-associated ulcerative cystitis: a new clinical entity. Urology 2007; 69:810–812. 90. Zarate CA, Jr, et al. Replication of ketamine’s antidepressant efficacy in bipolar depression: a randomized controlled add-on trial. Biol Psychiatry 2012; 71:939–946. 91. Permoda-Osip A, et al. Single ketamine infusion and neurocognitive performance in bipolar depression. Pharmacopsychiatry 2015; 48:78–79. 92. Jha MK, et al. Psychopharmacology and experimental therapeutics for bipolar depression. Focus (Am Psychiatr Publ) 2019; 17:232–237. 93. Włodarczyk A, et al. Safety and tolerability of ketamine use in treatment-resistant bipolar depression patients with regard to central nervous system symptomatology: literature review and analysis. Medicina (Kaunas) 2020; 56:67. 94. Bahji A, et al. Comparative efficacy of racemic ketamine and esketamine for depression: a systematic review and meta-analysis. J Affect Disord 2021; 278:542–555. 95. Alison McInnes L, et al. Possible affective switch associated with intravenous ketamine treatment in a patient with bipolar I disorder. Biol Psychiatry 2016; 79:e71–e72. 96. Goldberg JF, et al. Preliminary randomized, double-blind, placebo-controlled trial of pramipexole added to mood stabilizers for treatment- resistant bipolar depression. Am J Psychiatry 2004; 161:564–566. 97. Zarate CA, Jr, et al. Pramipexole for bipolar II depression: a placebo-controlled proof of concept study. Biol Psychiatry 2004; 56:54–60. 98. Romeo B, et al. Meta-analysis and review of dopamine agonists in acute episodes of mood disorder: efficacy and safety. J Psychopharmacol 2018; 32:385–396. 99. Ketter TA, et al. Adjunctive aripiprazole in treatment-resistant bipolar depression. Ann Clin Psychiatry 2006; 18:169–172. 100. Mazza M, et al. Beneficial acute antidepressant effects of aripiprazole as an adjunctive treatment or monotherapy in bipolar patients unresponsive to mood stabilizers: results from a 16-week open-label trial. Expert Opin Pharmacother 2008; 9:3145–3149. 101. Sidor MM, et al. Antidepressants for the acute treatment of bipolar depression: a systematic review and meta-analysis. J Clin Psychiatry 2011; 72:156–167. 102. Cruz N, et al. Efficacy of modern antipsychotics in placebo-controlled trials in bipolar depression: a meta-analysis. Int J Neuropsychopharmacol 2010; 13:5–14. 103. Dilsaver SC, et al. Treatment of bipolar depression with carbamazepine: results of an open study. Biol Psychiatry 1996; 40:935–937. 104. Wang PW, et al. Gabapentin augmentation therapy in bipolar depression. Bipolar Disord 2002; 4:296–301. 105. Ashton H, et al. GABA-ergic drugs: exit stage left, enter stage right. J Psychopharmacol 2003; 17:174–178. 106. Chengappa KN, et al. Inositol as an add-on treatment for bipolar depression. Bipolar Disord 2000; 2:47–55. 107. Young AH, et al. Improvements in neurocognitive function and mood following adjunctive treatment with mifepristone (RU-486) in bipolar disorder. Neuropsychopharmacology 2004; 29:1538–1545. 108. Watson S, et al. A randomized trial to examine the effect of mifepristone on neuropsychological performance and mood in patients with bipolar depression. Biol Psychiatry 2012; 72:943–949. 109. Nunez NA, et al. Efficacy and tolerability of adjunctive modafinil/armodafinil in bipolar depression: a meta-analysis of randomized controlled trials. Bipolar Disord 2020; 22:109–120. 110. Lipschitz JM, et al. Modafinil’s effects on cognition and sleep quality in affectively-stable patients with bipolar disorder: a pilot study. Front Psychiatry 2023; 14:1246149. 111. Frangou S, et al. Efficacy of ethyl-eicosapentaenoic acid in bipolar depression: randomised double-blind placebo-controlled study. Br J Psychiatry 2006; 188:46–50. 112. Keck PE, Jr, et al. Double-blind, randomized, placebo-controlled trials of ethyl-eicosapentanoate in the treatment of bipolar depression and rapid cycling bipolar disorder. Biol Psychiatry 2006; 60:1020–1022. 113. Zhang M, et al. Assessment of causal relationships between omega-3 and omega-6 polyunsaturated fatty acids in bipolar disorder: a 2-sample bidirectional mendelian randomization study. Food Funct 2023; 14:6200–6211. 114. Taylor DM, et al. Comparative efficacy and acceptability of drug treatments for bipolar depression: a multiple-treatments meta-analysis. Acta Psychiatr Scand 2014; 130:452–469.
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