Effects of Flibanserin on the Pre- and Post-menopausal Female Brain

Hypoactive Sexual Desire Disorder Clinical Trial

Official title:

Flibanserin and Women With Hypoactive Sexual Desire Disorder: A Double-Blind, Randomized, Electrical Neuroimaging Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02770768
• Other study ID #: IRB16-0087
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2016
• Est. completion date: December 21, 2021

Study information

• Verified date: January 2021
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the present study is to understand the neurobiological mechanisms of action underlying sexual desire building on prior work Dr. Stephanie Cacioppo has done in which desire was not manipulated. In the present project, Dr. Stephanie Cacioppo is manipulating desire through Flibanserin (Addyi) vs. placebo and she will be measuring subjective sexual desire as a manipulation check. The investigators will address this goal using a double-blind randomized outpatient design and determine the pre-post neurobehavioral change in the Flibanserin group and investigate the extent to which Flibanserin normalizes brain activity in premenopausal women with HSDD and the extent to which regional brain activation is associated with changes in symptoms and behavior (as measured with self-report measures of sexual desire and/or eye-tracking movements).

Description:

Hypoactive sexual desire disorder (HSDD) is the most common sexual complaint in women. Over the past 8 years, Dr. Stephanie Cacioppo has developed and validated the Desire Intention task, in which individuals are instructed to indicate as rapidly and as accurately as possible whether or not each visually presented stimulus (e.g., attractive persons of the opposite sex) is sexually desirable to them at the moment of the experiment. Flibanserin (Addyi) is a new medication approved by the FDA for the treatment of HSDD in pre-menopausal women. The investigators propose a study using the DIT to determine the extent to which Flibanserin normalizes brain activity in women with HSDD and the extent to which regional brain activation is associated with changes in symptoms and behavior.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 21, 2021
• Est. primary completion date: December 21, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 74 Years

Eligibility

Inclusion Criteria:

• Female
• Ages 21-45 or 51-74
• Pre- or Postmenopausal
• DSM-5 diagnosis of hypoactive sexual desire disorder (HSDD)
• Right-handed

Exclusion Criteria:

• Male
• Pregnant women
• Nursing women
• Post-menopausal women
• Women who report not being able to stop drinking alcohol during the duration of the study
• Currently taking psychotropic medication
• History of seizures or neurological disorders
• Under hormonal therapy
• Current or past diagnosis of cancer
• Any unstable medical illnesses
• Lifetime history of bipolar disorder, schizophrenia, or psychotic disorder
• Current or recent (past 3 months) substance abuse or dependence
• Current or recent (past 3 months) clinical depression
• Currently taking any medications that have/may have unfavorable interactions with Flibanserin

Related Conditions & MeSH terms

• Hypoactive Sexual Desire Disorder
• Hypokinesia
• Sexual Dysfunctions, Psychological

Intervention

Drug:
• Flibanserin
Observational study using electroencephalogram (EEG) and eye movement tracking device at baseline, week 4, and week 8 while subjects are taking either Flibanserin or matching placebo.
• Placebo
Observational study using electroencephalogram (EEG) and eye movement tracking device at baseline, week 4, and week 8 while subjects are taking either Flibanserin or matching placebo.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (7)

Bianchi-Demicheli F, Cojan Y, Waber L, Recordon N, Vuilleumier P, Ortigue S. Neural bases of hypoactive sexual desire disorder in women: an event-related FMRI study. J Sex Med. 2011 Sep;8(9):2546-59. doi: 10.1111/j.1743-6109.2011.02376.x. Epub 2011 Jun 30. — View Citation

Bolmont M, Cacioppo JT, Cacioppo S. Love is in the gaze: an eye-tracking study of love and sexual desire. Psychol Sci. 2014 Sep;25(9):1748-56. doi: 10.1177/0956797614539706. Epub 2014 Jul 16. — View Citation

Cacioppo S, Bianchi-Demicheli F, Frum C, Pfaus JG, Lewis JW. The common neural bases between sexual desire and love: a multilevel kernel density fMRI analysis. J Sex Med. 2012 Apr;9(4):1048-54. doi: 10.1111/j.1743-6109.2012.02651.x. Epub 2012 Feb 21. — View Citation

Cacioppo S, Cacioppo JT. Dynamic spatiotemporal brain analyses using high-performance electrical neuroimaging, Part II: A step-by-step tutorial. J Neurosci Methods. 2015 Dec 30;256:184-97. doi: 10.1016/j.jneumeth.2015.09.004. Epub 2015 Sep 10. — View Citation

Cacioppo S, Couto B, Bolmont M, Sedeno L, Frum C, Lewis JW, Manes F, Ibanez A, Cacioppo JT. Selective decision-making deficit in love following damage to the anterior insula. Curr Trends Neurol. 2013;7:15-19. — View Citation

Cacioppo S, Weiss RM, Runesha HB, Cacioppo JT. Dynamic spatiotemporal brain analyses using high performance electrical neuroimaging: theoretical framework and validation. J Neurosci Methods. 2014 Dec 30;238:11-34. doi: 10.1016/j.jneumeth.2014.09.009. Epub 2014 Sep 20. — View Citation

Ortigue S, Bianchi-Demicheli F. The chronoarchitecture of human sexual desire: a high-density electrical mapping study. Neuroimage. 2008 Nov 1;43(2):337-45. doi: 10.1016/j.neuroimage.2008.07.059. Epub 2008 Aug 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG Results: Evoked Brain Potentials (measured brain response that is the direct result of a specific cognitive event)	Change from baseline EEG results at 8 weeks. Average the electrical brain activity evoked by each type of stimuli to calculate the evoked brain potentials (any stereotyped electrophysical response to a stimulus).	8 weeks
Secondary	Eye movement tracking: movements to first saccades	Change from baseline eye movement tracking results at 8 weeks.	8 weeks