Hypoactive Sexual Desire Disorder
Conditions
Keywords
HSDD (Hypoactive Sexual Desire Disorder), EEG (Electroencephalogram)
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.
Interventions
DRUGFlibanserin
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.
DRUGPlacebo
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.
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EEG Results: Evoked Brain Potentials (Measured Brain Response That is the Direct Result of a Specific Cognitive Event) | 8 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eye Movement Tracking: Movements to First Saccades | 8 weeks | Change from baseline eye movement tracking results at 8 weeks. |
Countries
United States
Participant flow
Pre-assignment details
No participants started the trial and received the intervention.
Participants by arm
| Arm | Count |
|---|---|
| Flibanserin Drug: Flibanserin
* 8 weeks
* 100mg once daily at bedtime
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. | 0 |
| Placebo Drug: Matching Placebo Matching placebo capsules taken in same amount of pills as the active medication (for 8 weeks once daily at bedtime)
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. | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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).
Time frame: 8 weeks
Population: No data was collected or analyzed
Secondary
Eye Movement Tracking: Movements to First Saccades
Change from baseline eye movement tracking results at 8 weeks.
Time frame: 8 weeks
Population: No data was collected or analyzed