Effects of Flibanserin on the Pre- and Post-menopausal Female Brain
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - 74 |
| Updated: | 11/30/2018 |
| Start Date: | October 2016 |
| End Date: | June 1, 2019 |
| Contact: | Erika Kaske |
| Email: | ekaske@yoda.bsd.uchicago.edu |
| Phone: | 773-834-5264 |
Flibanserin and Women With Hypoactive Sexual Desire Disorder: A Double-Blind, Randomized, Electrical Neuroimaging Study
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).
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).
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.
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.
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
We found this trial at
1
site
5801 South Ellis Avenue
Chicago, Illinois 60637
Chicago, Illinois 60637
773.702.1234
Principal Investigator: Stephanie Cacioppo, PhD
Phone: 773-834-5264
University of Chicago One of the world's premier academic and research institutions, the University of...
Click here to add this to my saved trials
