drugset / Trial / NCT01208324
Estrogen and Serotonin on Changing Brain Chemistry
Completed
47 enrolled
University of Colorado, Denver
National Institute of Mental Health (NIMH) · collabUniversity of Pennsylvania · collab
RandomizedCrossoverDouble-blindTreatment
Summary
The aim of this study is to examine the effects of estrogen and serotonin on cognition, emotional processing, and brain activation. The investigators will study the effects of acute tryptophan (TRP) depletion on cognition and mood in healthy menopausal women before and after estrogen replacement treatment (ERT). Using functional magnetic resonance imaging (fMRI), the investigators will identify differences in brain activation during memory tasks with and without TRP depletion and before and after estrogen therapy in order to determine which brain regions and cognitive functions are affected by each manipulation.
Timeline
- Start
- 2010-03-04
- Primary completion
- 2018-11
- Completion
- 2018-11
Publications
- Background Epperson CN, Amin Z, Naftolin F, Cappiello A, Czarkowski KA, Stiklus S, Anderson GM, Krystal JH. The resistance to depressive relapse in menopausal women undergoing tryptophan depletion: preliminary findings. J Psychopharmacol. 2007 Jun;21(4):414-20. doi: 10.1177/0269881106067330. Epub 2006 Aug 4.
- Background Amin Z, Gueorguieva R, Cappiello A, Czarkowski KA, Stiklus S, Anderson GM, Naftolin F, Epperson CN. Estradiol and tryptophan depletion interact to modulate cognition in menopausal women. Neuropsychopharmacology. 2006 Nov;31(11):2489-97. doi: 10.1038/sj.npp.1301114. Epub 2006 Jun 7.
- Background Amin Z, Epperson CN, Constable RT, Canli T. Effects of estrogen variation on neural correlates of emotional response inhibition. Neuroimage. 2006 Aug 1;32(1):457-64. doi: 10.1016/j.neuroimage.2006.03.013. Epub 2006 Apr 27.
- Background Amin Z, Canli T, Epperson CN. Effect of estrogen-serotonin interactions on mood and cognition. Behav Cogn Neurosci Rev. 2005 Mar;4(1):43-58. doi: 10.1177/1534582305277152.
- Background Kugaya A, Epperson CN, Zoghbi S, van Dyck CH, Hou Y, Fujita M, Staley JK, Garg PK, Seibyl JP, Innis RB. Increase in prefrontal cortex serotonin 2A receptors following estrogen treatment in postmenopausal women. Am J Psychiatry. 2003 Aug;160(8):1522-4. doi: 10.1176/appi.ajp.160.8.1522.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Estradiol | Other / unclassified | 0.1 mg | Other |
| Comparator | Estradiol | Other / unclassified | 0.15 mg | Other |
| Comparator | L-Lysine | Other / unclassified | 4.8 g | Oral |
| Comparator | amino acids | Unknown | 1.5 g | Oral |
| Comparator | amino acids | Unknown | 3 g | Oral |
| Comparator | amino acids | Unknown | 4.2 g | Oral |
| Comparator | amino acids | Unknown | 4.8 g | Oral |
| Comparator | amino acids | Unknown | 6.6 g | Oral |