A Study of Pregnant and Postpartum Women With and Without Mood Disorders
NCT ID: NCT03615794
Last Updated: 2025-12-30
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
300 participants
Study Classification
OBSERVATIONAL
Study Start Date
2017-10-01
Study Completion Date
2024-05-06
Brief Summary
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This study is looking at genetic, biological, and environmental causes and how all three may work together to cause postpartum mood episodes. Participants will have psychiatric histories taken and will be monitored throughout pregnancy and during the postpartum period for the development of depressive or other mood episodes. Biological measures, including hormone levels, immunological measures, and growth factors will be collected. Environmental factors such as sleep deprivation and stress will also be measured. These factors will be considered in the setting of genetic and epigenetic data with the hope that investigators will ultimately be able to predict the onset of postpartum mood episodes in this vulnerable population.
Detailed Description
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Postpartum Depression (PPD) is a serious syndrome which resembles a major depressive episode and occurs in 10-20% of all mothers in the year following delivery. In addition, 20 - 30 % of women with Bipolar Disorder will experience postpartum psychosis (mania) and at least 20 % will experience a postpartum depression with some estimates as high as 65%. The postpartum time therefore represents a natural experiment that, in the setting of prospective monitoring, will allow the measurement of biological, genetic, and environmental factors that may impact the development of mood episodes.
Data was previously collected in "A Prospective Study of Postpartum Mood Episodes in Women with Affective disorders." Investigators followed 93 women with a history of a mood disorder (Major Depressive Disorder, Bipolar I, Bipolar II or Bipolar Not Otherwise Specified) through pregnancy and up to three months postpartum. This was a very ill sample and around 75% of the participants met Diagnostic and Statistical Manual (DSM)-IV criteria for a Major Depressive Episode either during pregnancy, postpartum or both. Of those that were well during the 3rd trimester (N=38), 40% became depressed within 4 weeks of delivery, despite the fact that 80% were taking psychiatric medications. Of those that developed Postpartum Depression, 53% had a family history of Postpartum Depression compared to 12% of those that did not develop Postpartum Depression, thus demonstrating a potential genetic basis for Postpartum Depression. Using this sample, investigators were able to identify epigenetic biomarkers that were predictive of Postpartum Depressive episodes.
Investigators now seek to replicate and extend investigators' previous findings by identifying and following a second sample of women with mood disorders through pregnancy and into the postpartum time period and, in addition, collect a sample of pregnant women who do not have a history of mood disorder as a control sample. These women will have psychiatric histories taken and will be monitored throughout pregnancy and during the postpartum period for the development of depressive or other mood episodes. In addition to clinical data, biological measures such as hormone levels, immunological measures and growth factors will be taken. Environmental factors such as sleep deprivation and stress will also be measured. These factors will be considered in the setting of genetic and epigenetic data with the hope that investigators will ultimately be able to predict the onset of postpartum mood episodes in this vulnerable population. An understanding of the biological basis of postpartum episodes will ultimately shed light on the vulnerability to Major Depressive Disorder and Bipolar Disorder in general
Data was previously collected in "A Prospective Study of Postpartum Mood Episodes in Women with Affective disorders." Investigators followed 93 women with a history of a mood disorder (Major Depressive Disorder, Bipolar I, Bipolar II or Bipolar Not Otherwise Specified) through pregnancy and up to three months postpartum. This was a very ill sample and around 75% of the participants met Diagnostic and Statistical Manual (DSM)-IV criteria for a Major Depressive Episode either during pregnancy, postpartum or both. Of those that were well during the 3rd trimester (N=38), 40% became depressed within 4 weeks of delivery, despite the fact that 80% were taking psychiatric medications. Of those that developed Postpartum Depression, 53% had a family history of Postpartum Depression compared to 12% of those that did not develop Postpartum Depression, thus demonstrating a potential genetic basis for Postpartum Depression. Using this sample, investigators were able to identify epigenetic biomarkers that were predictive of Postpartum Depressive episodes.
Investigators now seek to replicate and extend investigators' previous findings by identifying and following a second sample of women with mood disorders through pregnancy and into the postpartum time period and, in addition, collect a sample of pregnant women who do not have a history of mood disorder as a control sample. These women will have psychiatric histories taken and will be monitored throughout pregnancy and during the postpartum period for the development of depressive or other mood episodes. In addition to clinical data, biological measures such as hormone levels, immunological measures and growth factors will be taken. Environmental factors such as sleep deprivation and stress will also be measured. These factors will be considered in the setting of genetic and epigenetic data with the hope that investigators will ultimately be able to predict the onset of postpartum mood episodes in this vulnerable population. An understanding of the biological basis of postpartum episodes will ultimately shed light on the vulnerability to Major Depressive Disorder and Bipolar Disorder in general
Conditions
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Bipolar Disorder
Major Depressive Disorder
Postpartum Depression
Postpartum Psychosis
Study Design
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Observational Model Type
CASE_CONTROL
Study Time Perspective
PROSPECTIVE
Study Groups
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Pregnant women with Mood Disorders
Pregnant women with a history or current diagnosis of Major Depressive Disorder or Bipolar Disorder
No interventions assigned to this group
Healthy controls
Pregnant women without a history or current diagnosis of a mood disorder.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Pregnant women with singleton pregnancies
* With or without a history of a mood disorder (MDD, Bipolar I, Bipolar II or Bipolar NOS)
* With or without a history of a mood disorder (MDD, Bipolar I, Bipolar II or Bipolar NOS)
Exclusion Criteria
* Current active suicidal ideation
* Medical or psychiatric instability
* Active substance abuse or dependence during the last 90 days
* Presence or development of significant pregnancy conditions that may have independent effects on outcomes
* Medical or psychiatric instability
* Active substance abuse or dependence during the last 90 days
* Presence or development of significant pregnancy conditions that may have independent effects on outcomes
Minimum Eligible Age
18 Years
Maximum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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University of Virginia
OTHER
Sponsor Role
collaborator
Johns Hopkins University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jennifer Payne, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Richard Lee
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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550 North Broadway
Baltimore, Maryland, United States
Site Status
University of Virginia
Charlottesville, Virginia, United States
Site Status
Countries
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United States
References
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Viguera AC, Tondo L, Koukopoulos AE, Reginaldi D, Lepri B, Baldessarini RJ. Episodes of mood disorders in 2,252 pregnancies and postpartum periods. Am J Psychiatry. 2011 Nov;168(11):1179-85. doi: 10.1176/appi.ajp.2011.11010148. Epub 2011 Jul 28.
Reference Type
BACKGROUND
Wisner KL, Wheeler SB. Prevention of recurrent postpartum major depression. Hosp Community Psychiatry. 1994 Dec;45(12):1191-6. doi: 10.1176/ps.45.12.1191.
Reference Type
BACKGROUND
Wisner KL, Perel JM, Peindl KS, Hanusa BH, Findling RL, Rapport D. Prevention of recurrent postpartum depression: a randomized clinical trial. J Clin Psychiatry. 2001 Feb;62(2):82-6. doi: 10.4088/jcp.v62n0202.
Reference Type
BACKGROUND
Wisner KL, Perel JM, Peindl KS, Hanusa BH, Piontek CM, Findling RL. Prevention of postpartum depression: a pilot randomized clinical trial. Am J Psychiatry. 2004 Jul;161(7):1290-2. doi: 10.1176/appi.ajp.161.7.1290.
Reference Type
BACKGROUND
Yonkers KA, Ramin SM, Rush AJ, Navarrete CA, Carmody T, March D, Heartwell SF, Leveno KJ. Onset and persistence of postpartum depression in an inner-city maternal health clinic system. Am J Psychiatry. 2001 Nov;158(11):1856-63. doi: 10.1176/appi.ajp.158.11.1856.
Reference Type
BACKGROUND
Somerville S, Dedman K, Hagan R, Oxnam E, Wettinger M, Byrne S, Coo S, Doherty D, Page AC. The Perinatal Anxiety Screening Scale: development and preliminary validation. Arch Womens Ment Health. 2014 Oct;17(5):443-54. doi: 10.1007/s00737-014-0425-8. Epub 2014 Apr 4.
Reference Type
BACKGROUND
Akman I, Kuscu K, Ozdemir N, Yurdakul Z, Solakoglu M, Orhan L, Karabekiroglu A, Ozek E. Mothers' postpartum psychological adjustment and infantile colic. Arch Dis Child. 2006 May;91(5):417-9. doi: 10.1136/adc.2005.083790. Epub 2006 Feb 1.
Reference Type
BACKGROUND
Bernstein, D. and L. Fink, Manual for the childhood trauma questionnaire. The Psychological Corporation, New York, 1998
Reference Type
BACKGROUND
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. 2000 Jun;157(6):924-30. doi: 10.1176/appi.ajp.157.6.924.
Reference Type
BACKGROUND
Bratfos O, Haug JO. Puerperal mental disorders in manic-depressive females. Acta Psychiatr Scand. 1966;42(3):285-94. doi: 10.1111/j.1600-0447.1966.tb01933.x. No abstract available.
Reference Type
BACKGROUND
Campbell SB, Cohn JF. Prevalence and correlates of postpartum depression in first-time mothers. J Abnorm Psychol. 1991 Nov;100(4):594-9. doi: 10.1037//0021-843x.100.4.594.
Reference Type
BACKGROUND
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
Reference Type
BACKGROUND
Cohen LS, Nonacs RM, Bailey JW, Viguera AC, Reminick AM, Altshuler LL, Stowe ZN, Faraone SV. Relapse of depression during pregnancy following antidepressant discontinuation: a preliminary prospective study. Arch Womens Ment Health. 2004 Oct;7(4):217-21. doi: 10.1007/s00737-004-0059-3. Epub 2004 Aug 30.
Reference Type
BACKGROUND
Cohen LS, Altshuler LL, Harlow BL, Nonacs R, Newport DJ, Viguera AC, Suri R, Burt VK, Hendrick V, Reminick AM, Loughead A, Vitonis AF, Stowe ZN. Relapse of major depression during pregnancy in women who maintain or discontinue antidepressant treatment. JAMA. 2006 Feb 1;295(5):499-507. doi: 10.1001/jama.295.5.499.
Reference Type
BACKGROUND
Cox JL, Murray D, Chapman G. A controlled study of the onset, duration and prevalence of postnatal depression. Br J Psychiatry. 1993 Jul;163:27-31. doi: 10.1192/bjp.163.1.27.
Reference Type
BACKGROUND
Davidson J, Robertson E. A follow-up study of post partum illness, 1946-1978. Acta Psychiatr Scand. 1985 May;71(5):451-7. doi: 10.1111/j.1600-0447.1985.tb05057.x.
Reference Type
BACKGROUND
Dean C, Williams RJ, Brockington IF. Is puerperal psychosis the same as bipolar manic-depressive disorder? A family study. Psychol Med. 1989 Aug;19(3):637-47. doi: 10.1017/s0033291700024235.
Reference Type
BACKGROUND
Dietz PM, Williams SB, Callaghan WM, Bachman DJ, Whitlock EP, Hornbrook MC. Clinically identified maternal depression before, during, and after pregnancies ending in live births. Am J Psychiatry. 2007 Oct;164(10):1515-20. doi: 10.1176/appi.ajp.2007.06111893.
Reference Type
BACKGROUND
DiPietro JA, Costigan KA, Gurewitsch ED. Fetal response to induced maternal stress. Early Hum Dev. 2003 Nov;74(2):125-38. doi: 10.1016/j.earlhumdev.2003.07.001.
Reference Type
BACKGROUND
Field T. Prenatal depression effects on early development: a review. Infant Behav Dev. 2011 Feb;34(1):1-14. doi: 10.1016/j.infbeh.2010.09.008.
Reference Type
BACKGROUND
Flynn HA, Davis M, Marcus SM, Cunningham R, Blow FC. Rates of maternal depression in pediatric emergency department and relationship to child service utilization. Gen Hosp Psychiatry. 2004 Jul-Aug;26(4):316-22. doi: 10.1016/j.genhosppsych.2004.03.009.
Reference Type
BACKGROUND
Spinelli MG. Maternal infanticide associated with mental illness: prevention and the promise of saved lives. Am J Psychiatry. 2004 Sep;161(9):1548-57. doi: 10.1176/appi.ajp.161.9.1548.
Reference Type
BACKGROUND
Forty L, Jones L, Macgregor S, Caesar S, Cooper C, Hough A, Dean L, Dave S, Farmer A, McGuffin P, Brewster S, Craddock N, Jones I. Familiality of postpartum depression in unipolar disorder: results of a family study. Am J Psychiatry. 2006 Sep;163(9):1549-53. doi: 10.1176/ajp.2006.163.9.1549.
Reference Type
BACKGROUND
Frank E, Kupfer DJ, Jacob M, Blumenthal SJ, Jarrett DB. Pregnancy-related affective episodes among women with recurrent depression. Am J Psychiatry. 1987 Mar;144(3):288-93. doi: 10.1176/ajp.144.3.288.
Reference Type
BACKGROUND
Grace SL, Evindar A, Stewart DE. The effect of postpartum depression on child cognitive development and behavior: a review and critical analysis of the literature. Arch Womens Ment Health. 2003 Nov;6(4):263-74. doi: 10.1007/s00737-003-0024-6.
Reference Type
BACKGROUND
Guintivano J, Arad M, Gould TD, Payne JL, Kaminsky ZA. Antenatal prediction of postpartum depression with blood DNA methylation biomarkers. Mol Psychiatry. 2014 May;19(5):560-7. doi: 10.1038/mp.2013.62. Epub 2013 May 21.
Reference Type
BACKGROUND
20) Guy W. Clinical global impression. ECDEU Assessment Manual for Psychopharmacology, Revised 1976, National Institute of Mental Health, Rockville, MD.
Reference Type
BACKGROUND
Holmes TH, Rahe RH. The Social Readjustment Rating Scale. J Psychosom Res. 1967 Aug;11(2):213-8. doi: 10.1016/0022-3999(67)90010-4. No abstract available.
Reference Type
BACKGROUND
Jones I, Middle F, McCandless F, Coyle N, Robertson E, Brockington I, Lendon C, Craddock N. Molecular genetic studies of bipolar disorder and puerperal psychosis at two polymorphisms in the estrogen receptor alpha gene (ESR 1). Am J Med Genet. 2000 Dec 4;96(6):850-3. doi: 10.1002/1096-8628(20001204)96:63.0.co;2-1.
Reference Type
BACKGROUND
Jones I, Craddock N. Familiality of the puerperal trigger in bipolar disorder: results of a family study. Am J Psychiatry. 2001 Jun;158(6):913-7. doi: 10.1176/appi.ajp.158.6.913.
Reference Type
BACKGROUND
Jones I, Hamshere M, Nangle JM, Bennett P, Green E, Heron J, Segurado R, Lambert D, Holmans P, Corvin A, Owen M, Jones L, Gill M, Craddock N. Bipolar affective puerperal psychosis: genome-wide significant evidence for linkage to chromosome 16. Am J Psychiatry. 2007 Jul;164(7):1099-104. doi: 10.1176/ajp.2007.164.7.1099.
Reference Type
BACKGROUND
Kendell RE, Chalmers JC, Platz C. Epidemiology of puerperal psychoses. Br J Psychiatry. 1987 May;150:662-73. doi: 10.1192/bjp.150.5.662.
Reference Type
BACKGROUND
Kimmel M, Hess E, Roy PS, Palmer JT, Meltzer-Brody S, Meuchel JM, Bost-Baxter E, Payne JL. Family history, not lack of medication use, is associated with the development of postpartum depression in a high-risk sample. Arch Womens Ment Health. 2015 Feb;18(1):113-21. doi: 10.1007/s00737-014-0432-9. Epub 2014 Jul 1.
Reference Type
BACKGROUND
Lee KA. Self-reported sleep disturbances in employed women. Sleep. 1992 Dec;15(6):493-8. doi: 10.1093/sleep/15.6.493.
Reference Type
BACKGROUND
Mahon PB, Payne JL, MacKinnon DF, Mondimore FM, Goes FS, Schweizer B, Jancic D; NIMH Genetics Initiative Bipolar Disorder Consortium; BiGS Consortium; Coryell WH, Holmans PA, Shi J, Knowles JA, Scheftner WA, Weissman MM, Levinson DF, DePaulo JR Jr, Zandi PP, Potash JB. Genome-wide linkage and follow-up association study of postpartum mood symptoms. Am J Psychiatry. 2009 Nov;166(11):1229-37. doi: 10.1176/appi.ajp.2009.09030417. Epub 2009 Sep 15.
Reference Type
BACKGROUND
Marcus SM. Depression during pregnancy: rates, risks and consequences--Motherisk Update 2008. Can J Clin Pharmacol. 2009 Winter;16(1):e15-22. Epub 2009 Jan 22.
Reference Type
BACKGROUND
Meyer TJ, Miller ML, Metzger RL, Borkovec TD. Development and validation of the Penn State Worry Questionnaire. Behav Res Ther. 1990;28(6):487-95. doi: 10.1016/0005-7967(90)90135-6.
Reference Type
BACKGROUND
Murphy-Eberenz K, Zandi PP, March D, Crowe RR, Scheftner WA, Alexander M, McInnis MG, Coryell W, Adams P, DePaulo JR Jr, Miller EB, Marta DH, Potash JB, Payne J, Levinson DF. Is perinatal depression familial? J Affect Disord. 2006 Jan;90(1):49-55. doi: 10.1016/j.jad.2005.10.006. Epub 2005 Dec 5.
Reference Type
BACKGROUND
Misri S, Eng AB, Abizadeh J, Blackwell E, Spidel A, Oberlander TF. Factors impacting decisions to decline or adhere to antidepressant medication in perinatal women with mood and anxiety disorders. Depress Anxiety. 2013 Nov;30(11):1129-36. doi: 10.1002/da.22137. Epub 2013 Jun 18.
Reference Type
BACKGROUND
O'Donnell KJ, Bugge Jensen A, Freeman L, Khalife N, O'Connor TG, Glover V. Maternal prenatal anxiety and downregulation of placental 11beta-HSD2. Psychoneuroendocrinology. 2012 Jun;37(6):818-26. doi: 10.1016/j.psyneuen.2011.09.014. Epub 2011 Oct 15.
Reference Type
BACKGROUND
35) O'Hara MW, Varner, MW. (1986). Assessing stressful life events associated with childbearing: The Peripartum Events Scale. J of Repro and Inf Psych 4: 85-98.
Reference Type
BACKGROUND
O'Hara MW. Postpartum depression: what we know. J Clin Psychol. 2009 Dec;65(12):1258-69. doi: 10.1002/jclp.20644.
Reference Type
BACKGROUND
Payne JL, Roy PS, Murphy-Eberenz K, Weismann MM, Swartz KL, McInnis MG, Nwulia E, Mondimore FM, MacKinnon DF, Miller EB, Nurnberger JI, Levinson DF, DePaulo JR Jr, Potash JB. Reproductive cycle-associated mood symptoms in women with major depression and bipolar disorder. J Affect Disord. 2007 Apr;99(1-3):221-9. doi: 10.1016/j.jad.2006.08.013. Epub 2006 Oct 2.
Reference Type
BACKGROUND
Payne JL, MacKinnon DF, Mondimore FM, McInnis MG, Schweizer B, Zamoiski RB, McMahon FJ, Nurnberger JI Jr, Rice JP, Scheftner W, Coryell W, Berrettini WH, Kelsoe JR, Byerley W, Gershon ES, DePaulo JR Jr, Potash JB. Familial aggregation of postpartum mood symptoms in bipolar disorder pedigrees. Bipolar Disord. 2008 Feb;10(1):38-44. doi: 10.1111/j.1399-5618.2008.00455.x.
Reference Type
BACKGROUND
Reich T, Winokur G. Postpartum psychoses in patients with manic depressive disease. J Nerv Ment Dis. 1970 Jul;151(1):60-8. doi: 10.1097/00005053-197007000-00008. No abstract available.
Reference Type
BACKGROUND
Shadigian E, Bauer ST. Pregnancy-associated death: a qualitative systematic review of homicide and suicide. Obstet Gynecol Surv. 2005 Mar;60(3):183-90. doi: 10.1097/01.ogx.0000155967.72418.6b.
Reference Type
BACKGROUND
Shivakumar G, Johnson NL, McIntire DD, Leveno K. Progression of major depression during pregnancy and postpartum: a preliminary study. J Matern Fetal Neonatal Med. 2014 Apr;27(6):571-6. doi: 10.3109/14767058.2013.825599. Epub 2013 Aug 19.
Reference Type
BACKGROUND
Sichel DA, Cohen LS, Robertson LM, Ruttenberg A, Rosenbaum JF. Prophylactic estrogen in recurrent postpartum affective disorder. Biol Psychiatry. 1995 Dec 15;38(12):814-8. doi: 10.1016/0006-3223(95)00063-1.
Reference Type
BACKGROUND
Sit DK, Perel JM, Helsel JC, Wisner KL. Changes in antidepressant metabolism and dosing across pregnancy and early postpartum. J Clin Psychiatry. 2008 Apr;69(4):652-8. doi: 10.4088/jcp.v69n0419.
Reference Type
BACKGROUND
Yonkers KA, Gotman N, Smith MV, Forray A, Belanger K, Brunetto WL, Lin H, Burkman RT, Zelop CM, Lockwood CJ. Does antidepressant use attenuate the risk of a major depressive episode in pregnancy? Epidemiology. 2011 Nov;22(6):848-54. doi: 10.1097/EDE.0b013e3182306847.
Reference Type
BACKGROUND
Young RC, Biggs JT, Ziegler VE, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry. 1978 Nov;133:429-35. doi: 10.1192/bjp.133.5.429.
Reference Type
BACKGROUND
Other Identifiers
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IRB00027369
Identifier Type: -
Identifier Source: org_study_id