drugset / Trial / NCT01762943
Neurophysiology of Postpartum Depression in an Experimental Model of Pregnancy and Parturition
Completed
36 enrolled
University of North Carolina, Chapel Hill
Foundation of Hope, North Carolina · collabNational Alliance for Research on Schizophrenia and Depression · collabNational Institute of Mental Health (NIMH) · collabNational Institutes of Health (NIH) · collabNorth Carolina Translational and Clinical Sciences Institute · collab
Non-randomizedSingle-groupOpen-labelBasic science
Summary
Understanding the neural and biological mechanisms by which reproductive hormones influence mood is critically important for public health given that postpartum depression (PPD) is the leading cause of morbidity and mortality associated with childbirth and has negative effects on infants. Using a hormone-withdrawal challenge to precipitate mood symptoms will improve our ability to identify the biological mechanisms underlying both the triggering of and susceptibility to depressive disorders in women; and will permit the prediction of those at risk for PPD and other reproductive-related mood disorders.
Timeline
- Start
- 2013-08
- Primary completion
- 2016-10-13
- Completion
- 2016-10-13
Publications
- 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.
- Rudzinskas SA, Mazzu MA, Schiller CE, Meltzer-Brody S, Rubinow DR, Schmidt PJ, Goldman D. Divergent Transcriptomic Effects of Allopregnanolone in Postpartum Depression. Genes (Basel). 2023 Jun 8;14(6):1234. doi: 10.3390/genes14061234.
- Rudzinskas SA, Goff AC, Mazzu MA, Schiller CE, Meltzer-Brody S, Rubinow DR, Schmidt PJ, Goldman D. Intrinsically dysregulated cellular stress signaling genes and gene networks in postpartum depression. Mol Psychiatry. 2023 Jul;28(7):3023-3032. doi: 10.1038/s41380-023-01985-5. Epub 2023 Feb 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Estradiol | Other / unclassified | 10 mg | — |
| Subject | Leuprolide | Other / unclassified | 3.75 mg | Intramuscular |
| Subject | Progesterone | Other / unclassified | 800 mg | — |