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Antidepressant use in Bipolar Disorder: The ISBD Task Force Consensus Report

Antidepressant use in Bipolar Disorder: The ISBD Task Force Consensus Report. Eduard Vieta. Hagop Akiskal Lori Altshuler Jay D. Amsterdam Jean-Michel Azorin Ross J. Baldessarini Michael Bauer Michael Berk Boris Birmaher David J. Bond Charles L. Bowden Joseph R. Calabrese

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Antidepressant use in Bipolar Disorder: The ISBD Task Force Consensus Report

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  1. Antidepressant use in Bipolar Disorder: The ISBD Task Force Consensus Report Eduard Vieta

  2. HagopAkiskal LoriAltshuler Jay D. Amsterdam Jean-Michel Azorin Ross J. Baldessarini Michael Bauer Michael Berk Boris Birmaher David J. Bond Charles L. Bowden Joseph R. Calabrese Frederick Cassidy Francesc Colom Rif S. El-Mallakh Robert L. Findling Kostantinos N. Fountoulakis Mark A. Frye S. NassirGhaemi Paolo Girardi Joseph F. Goldberg Guy M. Goodwin Ana Gonzalez-Pinto Heinz Grunze Robert M.A. Hirschfeld Kyooseob Ha Diego Hidalgo Mazzei SiegfriedKasper ShigenobuKanba FlávioKapczinski TadafumiKato Terence A. Ketter Giorgio D. Kotzalidis AthanasiosKoukopoulos Beny Lafer Rasmus W. Licht Carlos Lopez-Jaramillo Glenda M MacQueen Gin S. Malhi Anabel Martinez-Aran Lorenzo Mazzarini Susan L. McElroy Philip B. Mitchell Andrew A. Nierenberg Willem A. Nolen Aysegul Ozerdem Gordon Parker Roy H. Perlis Giulio Perugi Robert R. Post Zoltan Rihmer Janusz Rybakowski Gary S. Sachs Alessandro Serretti Daniel Souery Michael E. Thase Mauricio Tohen Leonardo Tondo Juan Undurraga Marc Valentí Gustavo Vazquez Aysegul Yildiz Allan H. Young Lakshmi N. Yatham Eric A. Youngstrom Carlos A. Zarate ISBD Task-Force Expert Panel Chair: Eduard Vieta Coordinator: Isabella Pacchiarotti Task Force members were selected by citations on the topic over the past 3 years and geographical balance: 76% agreed to participate

  3. Volume of interactions during the process Draft revised and sent to journal 1st draft sent to authors 3rd draft sent to authors Sent to journal 2nd draft and 1st round survey 2nd round survey

  4. The need for a consensus • Is there a rational for starting ADs in BD? • Is there a rational for maintaining ADs during the long-term? • When ADs should be introduced? • How ADs should be introduced? • Which type of bipolar patients might benefit from the use of ADs? • In which type of bipolar patients the use of ADs should be avoided?

  5. Consensus method Consensus Method 1st Step:to assemble a group of experts of ADs in BD 65 authors agreed to participate 2nd Step: The ISBD Task-Force discussed and integrated the procedures through a face-to-face meeting (ISBD Congress, Istanbul, March, 2012) 3rd Step:The Task-Force drawed-up an updated systematic review through personal and group e-mail correspondence Delphi method 4th Step:The Task-Force provided a final guide of the use of ADs in BD

  6. Methods Methods 1. Search strategy PubMed search limited to human studies and strictly to ADs drugs 2. • Average quality (Jadad): • 0-2 = poor (not included) • 3-5 = acceptable or good (included) Systematic review • Efficacy studies • Safety studies • Levels of evidence (NHRMC): • A = Excellent • B = Good • C = Satisfactory • D = Poor 3. Delphi survey • Endorsed items:rated by ≥ 80% as essential or important • 1st round:items from literature • search • 2nd round:items rated • 3rd round:items re-rated • Re-rated items:rated as essential or important by 65%–79% • Rejected items:items with lower consensus levels

  7. Flow-diagram of study design and results Search results: limit to human studies ADs and bipolar disorder/ mania, depression, mixed state, safety, switch, suicide, side effects: 1,359 Not included: 1,187; 110, incongruent with aims; 379, low level of evidence/quality; 299, unfocused; 399, methodological flaws and doubles Included: 173 Observational: 33 Other open: 7 - n>100 - relevant outcomes Overlap between typologies of studies included in the review:0% RCT:97 - n ≥10/group - Statistically reliable findings Reviews/Meta-analyses: 6/30

  8. Results: evidence and quality Topic Average quality Evidence level

  9. Recommendations

  10. 1. Acute treatment 1.Adjunctive ADs may be used for an acute bipolar I or II depressive episode when there is a history of previous positive response to ADs. 86.88 Essential/ Important 13.12 Other 2.Adjunctive ADs should be avoided for an acute bipolar I or II depressive episode with two or more concomitant core manic symptoms, in presence of psychomotor agitation or rapid cycling. 88.53 Essential/ Important 11.47 Other

  11. 2. Maintenance treatment *Re-rated 3.Maintenance treatment with adjunctive antidepressants may be considered if a patient relapses into a depressive episode after stopping AD therapy. 85.00 Essential/ Important 15.00 Other

  12. 4. Switch to (hypo)mania or mixed states and rapid cycling 6.Bipolar patients starting ADs should be closely monitored for signs of hypomania or mania and increased psychomotor agitation in which case ADs should be discontinued. 93.44 Essential/ Important 6.56 Other 7.The use of ADs should be discouraged if there is history of past mania, hypomania or mixed episodes emerging during AD treatment. 83.61 Essential/ Important 16.39 Other 8.AD use should be avoided in bipolar patients with a high mood instability (i.e., high number of episodes) or with a history of rapid cycling. 85.25 Essential/ Important 14.75 Other

  13. 3. AD monotherapy 91.80 Essential/ Important 4.AD mono-therapy should be avoided in bipolar I disorder. 8.20 Other 5.AD mono-therapy should be avoided in bipolar I and II depression with two or more concomitant core manic symptoms. 85.24 Essential/ Important 14.76 Other

  14. 5. Use in mixed states 9.ADs should be avoided during manic and depressive episodes with mixed features. 95.08 Essential/ Important 4.92 Other 10.ADs should be avoided in bipolar patients with predominantly mixed states. 80.32 Essential/ Important 19.68 Other 11.Previously prescribed ADs should be discontinued in patients experiencing current mixed states. 83.61 Essential/ Important 16.39 Other

  15. 6. Drug class 12.Adjunctive treatment with SNRIs and TCAs should be considered only after other ADs have been tried, and should be closely monitored due to increased risk of switch or mood destabilization. 83.61 Essential/ Important 16.39 Other

  16. Rejected items 1.The use of adjunctive ADs may be considered for an acute bipolar depressive episode only after treatment with mood stabilizers or atypical antipsychotics with evidence of efficacy for bipolar depression has been tried without clinical benefits. 75.00% Essential/ Important *Re-rated 2.If a patient responds to an AD for an acute depressive episode, continuing ADs in the long-term might be reasonable in bipolar I or II subjects, with the exception of rapid cyclers and highly unstable bipolar patients. 62.29% Essential/ Important 3.If a patient responds to an AD for an acute depressive episode, it should be continued to full clinical remission of the index episode and then gradually removed. 60.65% Essential/ Important

  17. Rejected items 4.AD mono-therapy should be avoided during a first depressive episode in patients with no history of mania or hypomania but with two or more indicators of latent “bipolarity” 54.09% Essential/ Important 5.AD mono-therapy should be avoided in bipolar II disorder. Essential/ Important 42.62% 6. AD mono-therapy may be considered in a subgroup of bipolar II patients who have infrequent hypomanic episodes but long protracted depressive episodes. 70.00% Essential/ Important *Re-rated 7. The use of ADs should be avoided during a current depressive episode that is preceded by a recent manic/hypomanic (rather than euthymic) phase of the illness or in patients with manic predominant polarity. 44.27% Essential/ Important *Re-rated

  18. Rejected items 8. Among the different ADs, the SSRIs (especially fluoxetine), bupropion, and MAOIs should be preferred over other ADs as adjunctive treatment to mood stabilizers and/or atypical antipsychotics in bipolar I depression. 71.66% Essential/ Important *Re-rated 9.In bipolar II disorder, SSRI monotherapy may be considered in a subgroup of patients who have infrequent hypomanic episodes but long protracted depressive episodes. Essential/ Important 60.66% 10. TCA and SNRI monotherapy should be avoided in bipolar I and II disorder. 76.67% Essential/ Important *Re-rated 11. Adjunctive ADs may be used as a second line treatment choice after failure of mood stabilizers and/or atypical antipsychotics in bipolar patients with comorbid anxiety disorders. 62.29% Essential/ Important

  19. ISBD Task-Force Expert Panel

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