Cariprazine Augmentation in Treatment-Resistant Bipolar Depression: Data from a Retrospective Observational Study


如何引用文章

全文:

详细

Background:Treatment-resistant bipolar depression is one of the leading problems in psychiatry with serious consequences on patients functioning, quality of life and resource utilization. Despite this, there is a lack of consensus on diagnostic criteria and treatment algorithms.

Objective:The objective of the present study is to assess the acute effectiveness and tolerability of cariprazine in the management of treatment resistant bipolar depression.

Methods:This is a four weeks retrospective multicentric observational study on patients with treatment resistant bipolar depression receiving cariprazine in augmentation to the current treatment. Cariprazine dosage changed during the follow-up period according to clinical judgment. Since data followed a non-normal distribution, non-parametric tests were used to pursue the analysis. The effectiveness of cariprazine was assessed through the mean change in Hamilton Depression rating scale (HAM-D) scores from baseline to endpoint. For missing values, a "Last Observation Carried Forward" approach was applied

Results:Fifty-one patients were enrolled. Four patients (7.8%) discontinued cariprazine mainly due to adverse events. Mean cariprazine dose was 1.7 mg/day. The mean HAM-D score decreased significantly from baseline (T0) to week 4 (T4) at each evaluation point. Fourty-five one percent of the patients benefited of cariprazine add-on strategy: 23.5% achieved a clinical response and 21.6% were remitters. Among the completers, 70.6% experienced at least one adverse event. All side effects were mild to moderate.

Conclusion:Cariprazine seems to be an effective and well tolerated option in the management of patients with treatment resistant bipolar depression.

作者简介

Elena Teobaldi

Department of Neurosciences, University of Turin

Email: info@benthamscience.net

Enrico Pessina

Department of Mental Health, Community Mental Health Center

Email: info@benthamscience.net

Azzurra Martini

Department of Mental Health, Community Mental Health Center

Email: info@benthamscience.net

Carlo Cattaneo

Department of Mental Health,

Email: info@benthamscience.net

Domenico De Berardis

Department of Mental Health, Psychiatric Service for Diagnosis and Treatment, Hospital "G. Mazzini"

Email: info@benthamscience.net

Vassilis Martiadis

Department of Mental Health, ASL Napoli 1 Centro

Email: info@benthamscience.net

Giuseppe Maina

Department of Neurosciences, University of Turin

编辑信件的主要联系方式.
Email: info@benthamscience.net

Gianluca Rosso

Department of Neurosciences, University of Turin

Email: info@benthamscience.net

参考

  1. Judd, L.L.; Akiskal, H.S.; Schettler, P.J.; Endicott, J.; Maser, J.; Solomon, D.A.; Leon, A.C.; Rice, J.A.; Keller, M.B. The long-term natural history of the weekly symptomatic status of bipolar I disorder. Arch. Gen. Psychiatry, 2002, 59(6), 530-537. doi: 10.1001/archpsyc.59.6.530 PMID: 12044195
  2. Judd, L.L.; Akiskal, H.S.; Schettler, P.J.; Coryell, W.; Endicott, J.; Maser, J.D.; Solomon, D.A.; Leon, A.C.; Keller, M.B. 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. doi: 10.1001/archpsyc.60.3.261 PMID: 12622659
  3. Colom, F.; Vieta, E.; Daban, C.; Pacchiarotti, I.; Sánchez-Moreno, J. Clinical and therapeutic implications of predominant polarity in bipolar disorder. J. Affect. Disord., 2006, 93(1-3), 13-17. doi: 10.1016/j.jad.2006.01.032 PMID: 16650901
  4. McIntyre, R.S.; Suppes, T.; Earley, W.; Patel, M.; Stahl, S.M. Cariprazine efficacy in bipolar I depression with and without concurrent manic symptoms: Post hoc analysis of 3 randomized, placebo-controlled studies. CNS Spectr., 2020, 25(4), 502-510. doi: 10.1017/S1092852919001287 PMID: 31576791
  5. Kupka, R.W.; Altshuler, L.L.; Nolen, W.A.; Suppes, T.; Luckenbaugh, D.A.; Leverich, G.S.; Frye, M.A.; Keck, P.E., Jr; McElroy, S.L.; Grunze, H.; Post, R.M. Three times more days depressed than manic or hypomanic in both bipolar I and bipolar II disorder. Bipolar Disord., 2007, 9(5), 531-535. doi: 10.1111/j.1399-5618.2007.00467.x PMID: 17680925
  6. Malhi, G.S.; Ivanovski, B.; Hadzi-Pavlovic, D.; Mitchell, P.B.; Vieta, E.; Sachdev, P. Neuropsychological deficits and functional impairment in bipolar depression, hypomania and euthymia. Bipolar Disord., 2007, 9(1-2), 114-125. doi: 10.1111/j.1399-5618.2007.00324.x PMID: 17391355
  7. Gutirrez-Rojas, L.; Gurpegui, M.; Ayuso-Mateos, J.L.; Gutirrez-Ariza, J.A.; Ruiz-Veguilla, M.; Jurado, D. Quality of life in bipolar disorder patients: A comparison with a general population sample. Bipolar Disord., 2008, 10(5), 625-634. doi: 10.1111/j.1399-5618.2008.00604.x PMID: 18657247
  8. Bauer, M.; Ritter, P.; Grunze, H.; Pfennig, A. Treatment options for acute depression in bipolar disorder. Bipolar Disord., 2012, 14(2), 37-50. doi: 10.1111/j.1399-5618.2012.00991.x PMID: 22510035
  9. Hidalgo-Mazzei, D.; Berk, M.; Cipriani, A.; Cleare, A.J.; Florio, A.D.; Dietch, D.; Geddes, J.R.; Goodwin, G.M.; Grunze, H.; Hayes, J.F.; Jones, I.; Kasper, S.; Macritchie, K.; McAllister-Williams, R.H.; Morriss, R.; Nayrouz, S.; Pappa, S.; Soares, J.C.; Smith, D.J.; Suppes, T.; Talbot, P.; Vieta, E.; Watson, S.; Yatham, L.N.; Young, A.H.; Stokes, P.R.A. Treatment-resistant and multi-therapy-resistant criteria for bipolar depression: Consensus definition. Br. J. Psychiatry, 2019, 214(1), 27-35. doi: 10.1192/bjp.2018.257 PMID: 30520709
  10. De Fruyt, J.; Deschepper, E.; Audenaert, K.; Constant, E.; Floris, M.; Pitchot, W.; Sienaert, P.; Souery, D.; Claes, S. Second generation antipsychotics in the treatment of bipolar depression: A systematic review and meta-analysis. J. Psychopharmacol., 2012, 26(5), 603-617. doi: 10.1177/0269881111408461 PMID: 21940761
  11. Geddes, J.R.; Calabrese, J.R.; Goodwin, G.M. Lamotrigine for treatment of bipolar depression: Independent meta-analysis and meta-regression of individual patient data from five randomised trials. Br. J. Psychiatry, 2009, 194(1), 4-9. doi: 10.1192/bjp.bp.107.048504 PMID: 19118318
  12. Yatham, L.N.; Calabrese, J.R.; Kusumakar, V. Bipolar depression: Criteria for treatment selection, definition of refractoriness, and treatment options. Bipolar Disord., 2003, 5(2), 85-97. doi: 10.1034/j.1399-5618.2003.00019.x PMID: 12680897
  13. Sidor, M.M.; MacQueen, G.M. Antidepressants for the acute treatment of bipolar depression: A systematic review and meta-analysis. J. Clin. Psychiatry, 2011, 72(2), 156-167. doi: 10.4088/JCP.09r05385gre PMID: 21034686
  14. D’Urso, G.; Toscano, E.; Barone, A.; Palermo, M.; Dell’Osso, B.; Di Lorenzo, G.; Mantovani, A.; Martinotti, G.; Fornaro, M.; Iasevoli, F.; de Bartolomeis, A. Transcranial direct current stimulation for bipolar depression: systematic reviews of clinical evidence and biological underpinnings. Prog. Neuropsychopharmacol. Biol. Psychiatry, 2023, 121, 110672. doi: 10.1016/j.pnpbp.2022.110672 PMID: 36332699
  15. Kishi, T.; Ikuta, T.; Sakuma, K.; Hatano, M.; Matsuda, Y.; Kito, S.; Iwata, N. Repetitive transcranial magnetic stimulation for bipolar depression: A systematic review and pairwise and network meta-analysis. Mol. Psychiatry, 2023. doi: 10.1038/s41380-023-02045-8 PMID: 37020049
  16. Fornaro, M.; De Berardis, D.; Koshy, A.; Perna, G.; Vancampfort, D.; Stubbs, B.; Valchera, A. Prevalence and clinical features associated with bipolar disorder polypharmacy: A systematic review. Neuropsychiatr. Dis. Treat., 2016, 12, 719-735. doi: 10.2147/NDT.S100846 PMID: 27099503
  17. Stahl, S.M. Mechanism of action of cariprazine. CNS Spectr., 2016, 21(2), 123-127. doi: 10.1017/S1092852916000043 PMID: 26956157
  18. Gyertyán, I.; Sághy, K.; Laszy, J.; Elekes, O.; Kedves, R.; Gémesi, L.I.; Pásztor, G.; Zájer-Balázs, M.; Kapás, M.; Ágai Csongor, É.; Domány, G.; Kiss, B.; Szombathelyi, Z. Subnanomolar dopamine D3 receptor antagonism coupled to moderate D2 affinity results in favourable antipsychotic-like activity in rodent models: II. behavioural characterisation of RG-15. Naunyn Schmiedebergs Arch. Pharmacol., 2008, 378(5), 529-539. doi: 10.1007/s00210-008-0311-x PMID: 18548231
  19. Duric, V.; Banasr, M.; Franklin, T.; Lepack, A.; Adham, N.; Kiss, B.; Gyertyán, I.; Duman, R.S. Cariprazine exhibits anxiolytic and dopamine D3 receptor-dependent antidepressant effects in the chronic stress model. Int. J. Neuropsychopharmacol., 2017, 20(10), 788-796. doi: 10.1093/ijnp/pyx038 PMID: 28531264
  20. Do, A.; Keramatian, K.; Schaffer, A.; Yatham, L. Cariprazine in the treatment of bipolar disorder: Within and beyond clinical trials. Front. Psychiatry, 2021, 12, 769897. doi: 10.3389/fpsyt.2021.769897 PMID: 34970166
  21. Murphy, B.L.; Babb, S.M.; Ravichandran, C.; Cohen, B.M. Oral SAMe in persistent treatment-refractory bipolar depression: A double-blind, randomized clinical trial. J. Clin. Psychopharmacol., 2014, 34(3), 413-416. doi: 10.1097/JCP.0000000000000064 PMID: 24699040
  22. Martinotti, G.; Dell’Osso, B.; Di Lorenzo, G.; Maina, G.; Bertolino, A.; Clerici, M.; Barlati, S.; Rosso, G.; Di Nicola, M.; Marcatili, M.; d’Andrea, G.; Cavallotto, C.; Chiappini, S.; De Filippis, S.; Nicolò, G.; De Fazio, P.; Andriola, I.; Zanardi, R.; Nucifora, D.; Di Mauro, S.; Bassetti, R.; Pettorruso, M.; McIntyre, R.S.; Sensi, S.L.; di Giannantonio, M.; Vita, A. Treating bipolar depression with esketamine: Safety and effectiveness data from a naturalistic multicentric study on esketamine in bipolar versus unipolar treatment‐resistant depression. Bipolar Disord., 2023, 25(3), 233-244. doi: 10.1111/bdi.13296 PMID: 36636839
  23. Heerlein, K.; Perugi, G.; Otte, C.; Frodl, T.; Degraeve, G.; Hagedoorn, W.; Oliveira-Maia, A.J.; Perez Sola, V.; Rathod, S.; Rosso, G.; Sierra, P.; Malynn, S.; Morrens, J.; Verrijcken, C.; Gonzalez, B.; Young, A.H. Real-world evidence from a European cohort study of patients with treatment resistant depression: Treatment patterns and clinical outcomes. J. Affect. Disord., 2021, 290, 334-344. doi: 10.1016/j.jad.2021.03.073 PMID: 34044256
  24. Heerlein, K; De Giorgi, S; Degraeve, G; Frodl, T; Hagedoorn, W; Oliveira-Maia, AJ; Otte, C; Perez Sola, V; Rathod, S; Rosso, G; Sierra, P; Vita, A; Morrens, J; Rive, B; Mulhern, H.S; Kambarov, Y; Young, AH Real-world evidence from a European cohort study of patients with treatment resistant depression: Healthcare resource utilization. J. Affect. Disord., 2022, 298(Pt A), 442-450.
  25. Crown, W.H.; Finkelstein, S.; Berndt, E.R.; Ling, D.; Poret, A.W.; Rush, A.J.; Russell, J.M. The impact of treatment-resistant depression on health care utilization and costs. J. Clin. Psychiatry, 2002, 63(11), 963-971. doi: 10.4088/JCP.v63n1102 PMID: 12444808
  26. Fountoulakis, K.N.; Yatham, L.N.; Grunze, H.; Vieta, E.; Young, A.H.; Blier, P.; Tohen, M.; Kasper, S.; Moeller, H.J. The CINP Guidelines on the definition and evidence-based interventions for treatment-resistant bipolar disorder. Int. J. Neuropsychopharmacol., 2020, 23(4), 230-256. doi: 10.1093/ijnp/pyz064 PMID: 31802122
  27. Diaz, A.P.; Fernandes, B.S.; Quevedo, J.; Sanches, M.; Soares, J.C. Treatment-resistant bipolar depression: Concepts and challenges for novel interventions. Br. J. Psychiatry, 2022, 44(2), 178-186. doi: 10.1590/1516-4446-2020-1627 PMID: 34037084
  28. Malhi, G.S.; Bell, E.; Boyce, P.; Bassett, D.; Berk, M.; Bryant, R.; Gitlin, M.; Hamilton, A.; Hazell, P.; Hopwood, M.; Lyndon, B.; McIntyre, R.S.; Morris, G.; Mulder, R.; Porter, R.; Singh, A.B.; Yatham, L.N.; Young, A.; Murray, G. The 2020 royal australian and new zealand college of psychiatrists clinical practice guidelines for mood disorders: Bipolar disorder summary. Bipolar Disord., 2020, 22(8), 805-821. doi: 10.1111/bdi.13036 PMID: 33296123
  29. Blonde, L.; Khunti, K.; Harris, S.B.; Meizinger, C.; Skolnik, N.S. Interpretation and impact of real-world clinical data for the practicing clinician. Adv. Ther., 2018, 35(11), 1763-1774. doi: 10.1007/s12325-018-0805-y PMID: 30357570
  30. Román, V.; Gyertyán, I.; Sághy, K.; Kiss, B.; Szombathelyi, Z. Cariprazine (RGH-188), a D3-preferring dopamine D3/D2 receptor partial agonist antipsychotic candidate demonstrates anti-abuse potential in rats. Psychopharmacology, 2013, 226(2), 285-293. doi: 10.1007/s00213-012-2906-7 PMID: 23138433
  31. Yatham, LN; Vieta, E; McIntyre, RS; Jain, R; Patel, M; Earley, W Broad efficacy of cariprazine on depressive symptoms in bipolar disorder and the clinical implications. Prim. Care. Companion. CNS. Disord., 2020, 22(5), 20m02611. doi: 10.4088/PCC.20m02611
  32. Ragguett, R.M.; McIntyre, R.S. Cariprazine for the treatment of bipolar depression: A review. Expert Rev. Neurother., 2019, 19(4), 317-323. doi: 10.1080/14737175.2019.1580571 PMID: 30753085
  33. Joyce, J.N.; Millan, M.J. Dopamine D3 receptor antagonists as therapeutic agents. Drug Discov. Today, 2005, 10(13), 917-925. doi: 10.1016/S1359-6446(05)03491-4 PMID: 15993811
  34. Citrome, L.; Yatham, L.N.; Patel, M.D.; Barabássy, Á.; Hankinson, A.; Earley, W.R. Cariprazine and akathisia, restlessness, and extrapyramidal symptoms in patients with bipolar depression. J. Affect. Disord., 2021, 288, 191-198. doi: 10.1016/j.jad.2021.03.076 PMID: 33915374
  35. Earley, W.R.; Burgess, M.; Rekeda, L.; Hankinson, A.; McIntyre, R.S.; Suppes, T.; Calabrese, J.R.; Yatham, L.N. A pooled post hoc analysis evaluating the safety and tolerability of cariprazine in bipolar depression. J. Affect. Disord., 2020, 263, 386-395. doi: 10.1016/j.jad.2019.11.098 PMID: 31969269

补充文件

附件文件
动作
1. JATS XML

版权所有 © Bentham Science Publishers, 2024