Clinical trial NCT03740009 - References

Depression — Effects of a Tissue Selective Estrogen Complex (TSEC) on Depression and the Neural Reward System in the Perimenopause"

Citation(s)

•   ACOG Practice Bulletin No
  141: management of menopausal symptoms. Obstet Gynecol. 2014 Jan;123(1):202-216. doi: 10.1097/01.AOG.0000441353.20693.78. Erratum in: Obstet Gynecol. 2016 Jan;127(1):166. Obstet Gynecol. 2018 Mar;131(3):604.
•   Bless EP, McGinnis KA, Mitchell AL, Hartwell A, Mitchell JB
  The effects of gonadal steroids on brain stimulation reward in female rats. Behav Brain Res. 1997 Jan;82(2):235-44.
•   Bromberger JT, Matthews KA, Schott LL, Brockwell S, Avis NE, Kravitz HM, Everson-Rose SA, Gold EB, Sowers M, Randolph JF Jr
  Depressive symptoms during the menopausal transition: the Study of Women's Health Across the Nation (SWAN). J Affect Disord. 2007 Nov;103(1-3):267-72. Epub 2007 Feb 28.
•   Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ
  The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213.
•   Clark LA, Watson D, Mineka S
  Temperament, personality, and the mood and anxiety disorders. J Abnorm Psychol. 1994 Feb;103(1):103-16. Review.
•   Cohen LS, Soares CN, Vitonis AF, Otto MW, Harlow BL
  Risk for new onset of depression during the menopausal transition: the Harvard study of moods and cycles. Arch Gen Psychiatry. 2006 Apr;63(4):385-90.
•   Dichter GS, Kozink RV, McClernon FJ, Smoski MJ
  Remitted major depression is characterized by reward network hyperactivation during reward anticipation and hypoactivation during reward outcomes. J Affect Disord. 2012 Feb;136(3):1126-34. doi: 10.1016/j.jad.2011.09.048. Epub 2011 Oct 28.
•   First, M
  B., Spitzer, R. L., Gibbon, M. & Williams, J. B. W. Structured Clinical Interview for DSM-IV-TR Axis I Disorders, Research Version, Non-patient Edition. (SCID-I/NP). (Biometrics Research, New York State Psychiatric Institute, 2002).
•   Forbes EE, Hariri AR, Martin SL, Silk JS, Moyles DL, Fisher PM, Brown SM, Ryan ND, Birmaher B, Axelson DA, Dahl RE
  Altered striatal activation predicting real-world positive affect in adolescent major depressive disorder. Am J Psychiatry. 2009 Jan;166(1):64-73. doi: 10.1176/appi.ajp.2008.07081336. Epub 2008 Dec 1.
•   Gold EB, Bromberger J, Crawford S, Samuels S, Greendale GA, Harlow SD, Skurnick J
  Factors associated with age at natural menopause in a multiethnic sample of midlife women. Am J Epidemiol. 2001 May 1;153(9):865-74.
•   Greene JG
  Constructing a standard climacteric scale. Maturitas. 2008 Sep-Oct;61(1-2):78-84.
•   Grigoriadis S, Kennedy SH, Bagby RM
  A comparison of antidepressant response in younger and older women. J Clin Psychopharmacol. 2003 Aug;23(4):405-7.
•   Gyllstrom ME, Schreiner PJ, Harlow BL
  Perimenopause and depression: strength of association, causal mechanisms and treatment recommendations. Best Pract Res Clin Obstet Gynaecol. 2007 Apr;21(2):275-92. Epub 2006 Dec 12. Review.
•   Hale GE, Robertson DM, Burger HG
  The perimenopausal woman: endocrinology and management. J Steroid Biochem Mol Biol. 2014 Jul;142:121-31. doi: 10.1016/j.jsbmb.2013.08.015. Epub 2013 Oct 14. Review.
•   HAMILTON M
  A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23:56-62.
•   Harlow SD, Gass M, Hall JE, Lobo R, Maki P, Rebar RW, Sherman S, Sluss PM, de Villiers TJ; STRAW + 10 Collaborative Group
  Executive summary of the Stages of Reproductive Aging Workshop + 10: addressing the unfinished agenda of staging reproductive aging. Fertil Steril. 2012 Apr;97(4):843-51. doi: 10.1016/j.fertnstert.2012.01.128. Epub 2012 Feb 16.
•   Harlow SD, Gass M, Hall JE, Lobo R, Maki P, Rebar RW, Sherman S, Sluss PM, de Villiers TJ; STRAW 10 Collaborative Group
  Executive summary of the Stages of Reproductive Aging Workshop + 10: addressing the unfinished agenda of staging reproductive aging. Menopause. 2012 Apr;19(4):387-95. doi: 10.1097/gme.0b013e31824d8f40.
•   Kenna HA, Rasgon NL, Geist C, Small G, Silverman D
  Thalamo-Basal Ganglia connectivity in postmenopausal women receiving estrogen therapy. Neurochem Res. 2009 Feb;34(2):234-7. doi: 10.1007/s11064-008-9756-z. Epub 2008 Jun 6.
•   Kessler RC, Chiu WT, Demler O, Merikangas KR, Walters EE
  Prevalence, severity, and comorbidity of 12-month DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):617-27. Erratum in: Arch Gen Psychiatry. 2005 Jul;62(7):709. Merikangas, Kathleen R [added].
•   Kessler RC
  Epidemiology of women and depression. J Affect Disord. 2003 Mar;74(1):5-13.
•   Knutson B, Fong GW, Adams CM, Varner JL, Hommer D
  Dissociation of reward anticipation and outcome with event-related fMRI. Neuroreport. 2001 Dec 4;12(17):3683-7.
•   Masand PS, Gupta S
  Long-term side effects of newer-generation antidepressants: SSRIS, venlafaxine, nefazodone, bupropion, and mirtazapine. Ann Clin Psychiatry. 2002 Sep;14(3):175-82. Review.
•   McLendon Labs
  (2016). Follicle Stimulating Hormone (FSH). Retrieved from: http://www.uncmedicalcenter.org/mclendon-clinical-laboratories/available-tests/follicle-stimulating-hormone-fsh/
•   Pinkerton JV, Thomas S
  Use of SERMs for treatment in postmenopausal women. J Steroid Biochem Mol Biol. 2014 Jul;142:142-54. doi: 10.1016/j.jsbmb.2013.12.011. Epub 2013 Dec 25. Review.
•   Santen RJ, Allred DC, Ardoin SP, Archer DF, Boyd N, Braunstein GD, Burger HG, Colditz GA, Davis SR, Gambacciani M, Gower BA, Henderson VW, Jarjour WN, Karas RH, Kleerekoper M, Lobo RA, Manson JE, Marsden J, Martin KA, Martin L, Pinkerton JV, Rubinow DR, Teede H, Thiboutot DM, Utian WH; Endocrine Society
  Postmenopausal hormone therapy: an Endocrine Society scientific statement. J Clin Endocrinol Metab. 2010 Jul;95(7 Suppl 1):s1-s66. doi: 10.1210/jc.2009-2509. Epub 2010 Jun 21. Review.
•   Schiller CE, Johnson SL, Abate AC, Schmidt PJ, Rubinow DR
  Reproductive Steroid Regulation of Mood and Behavior. Compr Physiol. 2016 Jun 13;6(3):1135-60. doi: 10.1002/cphy.c150014. Review.
•   Schiller, C
  The hormone withdrawal hypothesis of postpartum depression: a translational approach. Theses Diss. (2011).
•   Schmidt PJ, Ben Dor R, Martinez PE, Guerrieri GM, Harsh VL, Thompson K, Koziol DE, Nieman LK, Rubinow DR
  Effects of Estradiol Withdrawal on Mood in Women With Past Perimenopausal Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Jul;72(7):714-26. doi: 10.1001/jamapsychiatry.2015.0111.
•   Schmidt PJ, Haq N, Rubinow DR
  A longitudinal evaluation of the relationship between reproductive status and mood in perimenopausal women. Am J Psychiatry. 2004 Dec;161(12):2238-44.
•   Schmidt PJ, Nieman L, Danaceau MA, Tobin MB, Roca CA, Murphy JH, Rubinow DR
  Estrogen replacement in perimenopause-related depression: a preliminary report. Am J Obstet Gynecol. 2000 Aug;183(2):414-20.
•   Schmidt PJ, Nieman LK, Danaceau MA, Adams LF, Rubinow DR
  Differential behavioral effects of gonadal steroids in women with and in those without premenstrual syndrome. N Engl J Med. 1998 Jan 22;338(4):209-16.
•   Thase ME, Entsuah R, Cantillon M, Kornstein SG
  Relative antidepressant efficacy of venlafaxine and SSRIs: sex-age interactions. J Womens Health (Larchmt). 2005 Sep;14(7):609-16.
•   Thomas J, Météreau E, Déchaud H, Pugeat M, Dreher JC
  Hormonal treatment increases the response of the reward system at the menopause transition: a counterbalanced randomized placebo-controlled fMRI study. Psychoneuroendocrinology. 2014 Dec;50:167-80. doi: 10.1016/j.psyneuen.2014.08.012. Epub 2014 Sep 1.
•   U
  S. Census Bureau. Age and Sex Composition: 2010. (2011).
•   Wassertheil-Smoller S, Hendrix SL, Limacher M, Heiss G, Kooperberg C, Baird A, Kotchen T, Curb JD, Black H, Rossouw JE, Aragaki A, Safford M, Stein E, Laowattana S, Mysiw WJ; WHI Investigators
  Effect of estrogen plus progestin on stroke in postmenopausal women: the Women's Health Initiative: a randomized trial. JAMA. 2003 May 28;289(20):2673-84.
•   Watson D, Clark LA, Tellegen A
  Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70.
•   Watson D, O'Hara MW, Simms LJ, Kotov R, Chmielewski M, McDade-Montez EA, Gamez W, Stuart S
  Development and validation of the Inventory of Depression and Anxiety Symptoms (IDAS). Psychol Assess. 2007 Sep;19(3):253-68.

Effects of a Tissue Selective Estrogen Complex (TESC) on Depression and the Neural Reward System in the Perimenopause

Details for clinical trial NCT03740009