drugset / Trial / NCT04278755
Binge Eating & Birth Control
Phase 2
Terminated
8 enrolled
University of North Carolina, Chapel Hill
Foundation of Hope, North Carolina · collab
NaSingle-groupOpen-labelBasic science
Summary
This pilot study examines the effect of stabilizing ovarian hormones on eating behaviors and brain activation in women with binge eating (n=15) using functional magnetic resonance imaging (fMRI) and behavioral tests. This is completed by taking oral contraceptives (birth control) continuously for three months. Prior to medication administration and at the end of treatment, eating behaviors will be measured and fMRI will be conducted in order to examine changes in activation in dopamine-reward pathways that occur with oral contraceptive administration. This will assess changes in brain activation that occur with the stabilization of ovarian hormones.
Timeline
- Start
- 2020-09-24
- Primary completion
- 2022-05-17
- Completion
- 2022-05-17
Publications
- Background American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders. Fifth Edition. 2013, Washington, DC: American Psychiatric Press.
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- Background Mogg K, Bradley BP. Some methodological issues in assessing attentional biases for threatening faces in anxiety: a replication study using a modified version of the probe detection task. Behav Res Ther. 1999 Jun;37(6):595-604. doi: 10.1016/s0005-7967(98)00158-2.
- Background Mogg, K., & Bradley, B. P. (2005). Attentional Bias in Generalized Anxiety Disorder Versus Depressive Disorder. Cognitive Therapy and Research, 29(1), 29-45. https://doi.org/10.1007/s10608-005-1646-y
- Background Moses-Kolko EL, Fraser D, Wisner KL, James JA, Saul AT, Fiez JA, Phillips ML. Rapid habituation of ventral striatal response to reward receipt in postpartum depression. Biol Psychiatry. 2011 Aug 15;70(4):395-9. doi: 10.1016/j.biopsych.2011.02.021. Epub 2011 Apr 20.
- Background Moses-Kolko EL, Perlman SB, Wisner KL, James J, Saul AT, Phillips ML. Abnormally reduced dorsomedial prefrontal cortical activity and effective connectivity with amygdala in response to negative emotional faces in postpartum depression. Am J Psychiatry. 2010 Nov;167(11):1373-80. doi: 10.1176/appi.ajp.2010.09081235. Epub 2010 Sep 15.
- Background Murphy KJ, Brunberg JA. Adult claustrophobia, anxiety and sedation in MRI. Magn Reson Imaging. 1997;15(1):51-4. doi: 10.1016/s0730-725x(96)00351-7.
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- Background Nieman, L. K., & Loriaux, D. L. (1992). Estrogens and progestins. In Textbook of pharmacology (pp. 695-716). Philadelphia, PA: W.B. Saunders Company.
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- Background Oates M. Perinatal psychiatric disorders: a leading cause of maternal morbidity and mortality. Br Med Bull. 2003;67:219-29. doi: 10.1093/bmb/ldg011.
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- Background Perlis RH, Fraguas R, Fava M, Trivedi MH, Luther JF, Wisniewski SR, Rush AJ. Prevalence and clinical correlates of irritability in major depressive disorder: a preliminary report from the Sequenced Treatment Alternatives to Relieve Depression study. J Clin Psychiatry. 2005 Feb;66(2):159-66; quiz 147, 273-4.
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- Background Postpartum Depression: Action Towards Causes and Treatment (PACT) Consortium. Heterogeneity of postpartum depression: a latent class analysis. Lancet Psychiatry. 2015 Jan;2(1):59-67. doi: 10.1016/S2215-0366(14)00055-8. Epub 2015 Jan 8.
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- Background Prentice RL, Langer R, Stefanick ML, Howard BV, Pettinger M, Anderson G, Barad D, Curb JD, Kotchen J, Kuller L, Limacher M, Wactawski-Wende J; Women's Health Initiative Investigators. Combined postmenopausal hormone therapy and cardiovascular disease: toward resolving the discrepancy between observational studies and the Women's Health Initiative clinical trial. Am J Epidemiol. 2005 Sep 1;162(5):404-14. doi: 10.1093/aje/kwi223. Epub 2005 Jul 20.
- Background Price M, van Stolk-Cooke K. Examination of the interrelations between the factors of PTSD, major depression, and generalized anxiety disorder in a heterogeneous trauma-exposed sample using DSM 5 criteria. J Affect Disord. 2015 Nov 1;186:149-55. doi: 10.1016/j.jad.2015.06.012. Epub 2015 Jul 29.
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- Background Rich BA, Holroyd T, Carver FW, Onelio LM, Mendoza JK, Cornwell BR, Fox NA, Pine DS, Coppola R, Leibenluft E. A preliminary study of the neural mechanisms of frustration in pediatric bipolar disorder using magnetoencephalography. Depress Anxiety. 2010 Mar;27(3):276-86. doi: 10.1002/da.20649.
- Background Rich BA, Schmajuk M, Perez-Edgar KE, Fox NA, Pine DS, Leibenluft E. Different psychophysiological and behavioral responses elicited by frustration in pediatric bipolar disorder and severe mood dysregulation. Am J Psychiatry. 2007 Feb;164(2):309-17. doi: 10.1176/ajp.2007.164.2.309.
- Background Rich BA, Schmajuk M, Perez-Edgar KE, Pine DS, Fox NA, Leibenluft E. The impact of reward, punishment, and frustration on attention in pediatric bipolar disorder. Biol Psychiatry. 2005 Oct 1;58(7):532-9. doi: 10.1016/j.biopsych.2005.01.006. Epub 2005 Jun 13.
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- Background Stoddard J, Tseng WL, Kim P, Chen G, Yi J, Donahue L, Brotman MA, Towbin KE, Pine DS, Leibenluft E. Association of Irritability and Anxiety With the Neural Mechanisms of Implicit Face Emotion Processing in Youths With Psychopathology. JAMA Psychiatry. 2017 Jan 1;74(1):95-103. doi: 10.1001/jamapsychiatry.2016.3282.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | drospirenone | Unknown | 3 mg | Oral |
| Subject | ethinyl estradiol | Small molecule | 0.03 mg | Oral |