Brexanolone (SAGE-547 injection) in post-partum depression: a randomised controlled trial

The Lancet

Volumn 390, Issue 10093, 2017, Pages 480-489

  Kanes, Stephen ^a   Colquhoun, Helen ^a   Gunduz Bruce, Handan ^a   Raines, Shane ^b   Arnold, Ryan ^a   Schacterle, Amy ^a   Doherty, James ^a   Epperson, C Neill ^c   Deligiannidis, Kristina M ^d,e   Riesenberg, Robert ^f   Hoffmann, Ethan ^a   Rubinow, David ^g   Jonas, Jeffrey ^a   Paul, Steven ^a   Meltzer Brody, Samantha ^g  

^a Sage Therapeutics Inc   (United States)

^b 2b Analytics ^*  (United States)

^c UNIVERSITY OF PENNSYLVANIA   (United States)

^d UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL   (United States)

^e ZUCKER HILLSIDE HOSPITAL   (United States)

^f Atlanta Center for Medical Research   (United States)

^g UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

4 AMINOBUTYRIC ACID A RECEPTOR; BREXANOLONE; PLACEBO; ANTIDEPRESSANT AGENT; BETA CYCLODEXTRIN DERIVATIVE; ELTANOLONE;

ADULT; ANXIETY ASSESSMENT; ARTICLE; ASSESSMENT OF HUMANS; BARKIN INDEX OF MATERNAL FUNCTION; CLINICAL ARTICLE; CLINICAL GLOBAL IMPRESSION SCALE; COMPARATIVE STUDY; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG FORMULATION; DSM-5; EDINBURGH POSTNATAL DEPRESSION SCALE; FEMALE; GENERALISED ANXIETY DISORDER QUESTIONNAIRE; HAMILTON DEPRESSION RATING SCALE; HOSPITAL PATIENT; HUMAN; ICD-10; MONTGOMERY ASBERG DEPRESSION RATING SCALE; MULTICENTER STUDY; OUTCOME ASSESSMENT; PATIENT HEALTH QUESTIONNAIRE 9; PHYSICAL EXAMINATION; POSTNATAL DEPRESSION; PRIORITY JOURNAL; PUERPERIUM; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; SINGLE DRUG DOSE; SOMNOLENCE; STRUCTURED CLINICAL INTERVIEW FOR DSM DISORDERS; TACHYCARDIA; TREATMENT DURATION; CLINICAL TRIAL; DRUG COMBINATION; INTRAVENOUS DRUG ADMINISTRATION; PHASE 2 CLINICAL TRIAL; PSYCHOLOGICAL RATING SCALE; TREATMENT OUTCOME; YOUNG ADULT;

ADULT; ANTIDEPRESSIVE AGENTS; BETA-CYCLODEXTRINS; DEPRESSION, POSTPARTUM; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; PREGNANOLONE; PSYCHIATRIC STATUS RATING SCALES; TREATMENT OUTCOME; YOUNG ADULT;

EID: 85020628247     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(17)31264-3     Document Type: Article

References (54)

1. Gavin, NI, Gaynes, BN, Lohr, KN, Meltzer-Brody, S, Gartlehner, G, Swinson, T, Perinatal depression: a systematic review of prevalence and incidence. Obstet Gynecol 106 (2005), 1071–1083.
2. Howard, LM, Molyneaux, E, Dennis, CL, Rochat, T, Stein, A, Milgrom, J, Non-psychotic mental disorders in the perinatal period. Lancet 384 (2014), 1775–1788.
3. Fellmeth, G, Fazel, M, Plugge, E, Migration and perinatal mental health in women from low- and middle-income countries: a systematic review and meta-analysis. BJOG 124 (2017), 742–752.
4. Meltzer-Brody, S, Maegbaek, ML, Medland, SE, Miller, WC, Sullivan, P, Munk-Olsen, T, Obstetrical, pregnancy and socio-economic predictors for new-onset severe postpartum psychiatric disorders in primiparous women. Psychol Med 47 (2017), 1427–1441.
5. Kim, JJ, La Porte, LM, Saleh, MP, et al. Suicide risk among perinatal women who report thoughts of self-harm on depression screens. Obstet Gynecol 125 (2015), 885–893.
6. Postpartum Depression: Action Towards Causes and Treatment (PACT) Consortium. Heterogeneity of postpartum depression: a latent class analysis. Lancet Psychiatry 2 (2015), 59–67.
7. WHO. International statistical classification of diseases and related health problems, 1992, World Health Organization, Geneva 10th revision (ICD-10).
8. American Psychiatric Association. Diagnostic and statistical manual of mental disorders, 5th edn (DSM-5), 2013, American Psychiatric Publishing, Arlington, VA.
9. Johannsen, BM, Larsen, JT, Laursen, TM, Bergink, V, Meltzer-Brody, S, Munk-Olsen, T, All-cause mortality in women with severe postpartum psychiatric disorders. Am J Psychiatry 173 (2016), 635–642.
10. Khalifeh, H, Hunt, IM, Appleby, L, Howard, LM, Suicide in perinatal and non-perinatal women in contact with psychiatric services: 15 year findings from a UK national inquiry. Lancet Psychiatry 3 (2016), 233–242.
11. Noorlander, Y, Bergink, V, van Den Berg, MP, Perceived and observed mother-child interaction at time of hospitalization and release in postpartum depression and psychosis. Arch Womens Ment Health 11 (2008), 49–56.
12. Field, T, Postpartum depression effects on early interactions, parenting, and safety practices: a review. Infant Behav Dev 33 (2010), 1–6.
13. Epperson, CN, Jatlow, PI, Czarkowski, K, Anderson, GM, Maternal fluoxetine treatment in the postpartum period: effects on platelet serotonin and plasma drug levels in breastfeeding mother-infant pairs. Pediatrics, 112, 2003, e425.
14. Bloch, M, Schmidt, PJ, Danaceau, M, Murphy, J, Nieman, L, Rubinow, DR, Effects of gonadal steroids in women with a history of postpartum depression. Am J Psychiatry 157 (2000), 924–930.
15. Epperson, CN, Gueorguieva, R, Czarkowski, KA, et al. Preliminary evidence of reduced occipital GABA concentrations in puerperal women: a 1H-MRS study. Psychopharmacology (Berl) 186 (2006), 425–433.
16. Schiller, CE, Meltzer-Brody, S, Rubinow, DR, The role of reproductive hormones in postpartum depression. CNS Spectr 20 (2015), 48–59.
17. Paul, SM, Purdy, RH, Neuroactive steroids. FASEB J 6 (1992), 2311–2322.
18. Majewska, MD, Harrison, NL, Schwartz, RD, Barker, JL, Paul, SM, Steroid hormone metabolites are barbiturate-like modulators of the GABA receptor. Science 232 (1986), 1004–1007.
19. Deligiannidis, KM, Kroll-Desrosiers, AR, Mo, S, et al. Peripartum neuroactive steroid and γ-aminobutyric acid profiles in women at-risk for postpartum depression. Psychoneuroendocrinology 70 (2016), 98–107.
20. Zorumski, CF, Paul, SM, Izumi, Y, Covey, DF, Mennerick, S, Neurosteroids, stress and depression: potential therapeutic opportunities. Neurosci Biobehav Rev 37 (2013), 109–122.
21. Belelli, D, Harrison, NL, Maguire, J, Macdonald, RL, Walker, MC, Cope, DW, Extrasynaptic GABAA receptors: form, pharmacology, and function. J Neurosci 29 (2009), 12757–12763.
22. Luisi, S, Petraglia, F, Benedetto, C, et al. Serum allopregnanolone levels in pregnant women: changes during pregnancy, at delivery, and in hypertensive patients. J Clin Endocrinol Metab 85 (2000), 2429–2433.
23. Nappi, RE, Petraglia, F, Luisi, S, Polatti, F, Farina, C, Genazzani, AR, Serum allopregnanolone in women with postpartum “blues”. Obstet Gynecol 97 (2001), 77–80.
24. Maguire, J, Mody, I, GABA(A)R plasticity during pregnancy: relevance to postpartum depression. Neuron 59 (2008), 207–213.
25. Paoletti, AM, Romagnino, S, Contu, R, et al. Observational study on the stability of the psychological status during normal pregnancy and increased blood levels of neuroactive steroids with GABA-A receptor agonist activity. Psychoneuroendocrinology 31 (2006), 485–492.
26. Deligiannidis, KM, Sikoglu, EM, Shaffer, SA, et al. GABAergic neuroactive steroids and resting-state functional connectivity in postpartum depression: a preliminary study. J Psychiatr Res 47 (2013), 816–828.
27. Harris, B, Lovett, L, Smith, J, Read, G, Walker, R, Newcombe, R, Cardiff puerperal mood and hormone study. III. Postnatal depression at 5 to 6 weeks postpartum, and its hormonal correlates across the peripartum period. Br J Psychiatry 168 (1996), 739–744.
28. Milgrom, J, Gemmil, AW, Bilszta, JL, et al. Antenatal risk factors for postnatal depression: a large prospective study. J Affect Disord 108 (2008), 147–157.
29. Serati, M, Redaelli, M, Buoli, M, Altamura, AC, Perinatal major depression biomarkers: a systematic review. J Affect Disord 193 (2016), 391–404.
30. First, MB, Spitzer, RL, Gibbon, M, Williams, JBW, Structured clinical interview for DSM-IV axis I disorders, clinician version (SCID-CV), 1996, American Psychiatric Press, Washington, DC.
31. Zimmerman, M, Martinez, JH, Young, D, Chelminski, I, Dalrymple, K, Severity classification on the Hamilton Depression Rating Scale. J Affect Disord 150 (2013), 384–388.
32. Kanes, SJ, Colquhoun, H, Doherty, J, et al. Open-label, proof-of-concept study of brexanolone in the treatment of severe postpartum depression. Hum Psychopharmacol Clin Exp, 32, 2017, e2576.
33. Bech, P, Allerup, P, Gram, LF, et al. The Hamilton depression scale. Evaluation of objectivity using logistic models. Acta Psychiatr Scand 63 (1981), 290–299.
34. Montgomery, SA, Asberg, M, A new depression scale designed to be sensitive to change. Br J Psychiatry 134 (1979), 382–389.
35. W, Guy, ECDEU assessment manual for psychopharmacology: Rockville, MD: US Department of Health, Education, and Welfare, Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, National Institute of Mental Health, Psychopharmacology Research Branch, Division of Extramural Research Programs, 1976.
36. Spitzer, RL, Kroenke, K, Williams, JB, Lowe, B, A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med 166 (2006), 1092–1097.
37. Cox, JL, Holden, JM, Sagovsky, R, Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry 150 (1987), 782–786.
38. Spitzer, RL, Kroenke, K, Williams, JB, Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA 282 (1999), 1737–1744.
39. Barkin, JL, Wisner, KL, Wisniewski, SR, The psychometric properties of the Barkin Index of Maternal Functioning. J Obstet Gynecol Neonatal Nurs 43 (2014), 792–802.
40. Posner, KBG, Stanley, B, Brent, DA, et al. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry 168 (2011), 1266–1277.
41. Hoddes, E, Zarcone, V, Smythe, H, Phillips, R, Dement, WC, Quantification of sleepiness: a new approach. Psychophysiology 10 (1973), 431–436.
42. Yonkers, KA, Wisner, KL, Stewart, DE, et al. The management of depression during pregnancy: a report from the American Psychiatric Association and the American College of Obstetricians and Gynecologists. Obstet Gynecol 114 (2009), 703–713.
43. Hantsoo, L, D Ward-O'Brien, Czarkowski, KA, Gueorguieva, R, Price, LH, Epperson, CN, A randomized, placebo-controlled, double-blind trial of sertraline for postpartum depression. Psychopharmacology (Berl) 231 (2014), 939–948.
44. De Crescenzo, F, Perelli, F, Armando, M, Vicari, S, Selective serotonin reuptake inhibitors (SSRIs) for post-partum depression (PPD): a systematic review of randomized clinical trials. J Affect Disord 152–54 (2014), 39–44.
45. Hendrick, V, Altshuler, L, Strouse, T, Grosser, S, Postpartum and nonpostpartum depression: differences in presentation and response to pharmacologic treatment. Depress Anxiety 11 (2000), 66–72.
46. Epperson, CN, Anderson, GM, McDougle, CJ, Sertraline and breast-feeding. N Engl J Med 336 (1997), 1189–1190.
47. Cox, EQ, Sowa, NA, Meltzer-Brody, SE, Gaynes, BN, The perinatal depression treatment cascade: baby steps toward improving outcomes. J Clin Psychiatry 77 (2016), 1189–1200.
48. Fournier, JC, DeRubeis, RJ, Hollon, SD, et al. Antidepressant drug effects and depression severity: a patient-level meta-analysis. JAMA 303 (2010), 47–53.
49. Bech, P, Cialdella, P, Haugh, MC, et al. Meta-analysis of randomised controlled trials of fluoxetine v. placebo and tricyclic antidepressants in the short-term treatment of major depression. Br J Psychiatry 176 (2000), 421–428.
50. Murrough, JW, Iosifescu, DV, Chang, LC, et al. Antidepressant efficacy of ketamine in treatment-resistant major depression: a two-site randomized controlled trial. Am J Psychiatry 170 (2013), 1134–1142.
51. Zarate, C, Singh, JB, Carlson, PJ, et al. A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression. Arch Gen Psychiatry 63 (2006), 856–864.
52. Concas, A, Mostallino, MC, Porcu, P, et al. Role of brain allopregnanolone in the plasticity of γ-aminobutyric acid type A receptor in rat brain during pregnancy and after delivery. Proc Natl Acad Sci USA 95:13 (1998), 284–289.
53. Klak, J, Hill, M, Pařízek, A, et al. Pregnanolone isomers, pregnenolone and their polar conjugates around parturition. Physiol Res 52 (2003), 211–221.
54. van Calker, D, Zobel, I, Dykierek, P, et al. Time course of response to antidepressants: predictive value of early improvement and effect of additional psychotherapy. J Affect Disord 114 (2009), 243–253.