Clinical trial NCT02770768: Effects of Flibanserin on the Pre- and Post-menopausal Female Brain
Official title: Flibanserin and Women With Hypoactive Sexual Desire Disorder: A Double-Blind, Randomized, Electrical Neuroimaging Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypoactive Sexual Desire Disorder
Keywords: HSDD (Hypoactive Sexual Desire Disorder)
EEG (Electroencephalogram)
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2016-05-12
Enrollment: 57
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: EEG Results: Evoked Brain Potentials (Measured Brain Response That is the Direct Result of a Specific Cognitive Event)
timeFrame: 8 weeks
Secondary outcomes:
measure: Eye Movement Tracking: Movements to First Saccades
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Stephanie Cacioppo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Jon E Grant, MD, JD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.
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.
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.