Not provided
Not provided
Not provided
Not provided
Not provided
PI left institution cannot be contacted.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flibanserin | Active Comparator | Drug: Flibanserin
|
|
| Placebo | Placebo Comparator | Drug: Matching Placebo Matching placebo capsules taken in same amount of pills as the active medication (for 8 weeks once daily at bedtime) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flibanserin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Eye Movement Tracking: Movements to First Saccades | Change from baseline eye movement tracking results at 8 weeks. | 8 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephanie Cacioppo, PhD | University of Chicago | Principal Investigator |
| Jon E Grant, MD, JD, MPH | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21718449 | Background | 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. | |
| 25031302 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
No participants started the trial and received the intervention.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Flibanserin | Drug: Flibanserin
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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No data was collected or analyzed
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Flibanserin | Drug: Flibanserin
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. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | No data was collected or analyzed | Posted | 8 weeks |
|
All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed
All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Flibanserin | Drug: Flibanserin
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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Compliance Specialist | University of Chicago | 773-702-6505 | czwieg@bsd.uchicago.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 20, 2019 | May 6, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 17, 2019 | Apr 13, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D020018 | Sexual Dysfunctions, Psychological |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C098107 | flibanserin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | 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. |
|
|
| 22353205 | Background | 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. |
| 26363189 | Background | 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. |
| 25382944 | Background | 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. |
| 25244954 | Background | 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. |
| 18761412 | Background | 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. |
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. |
| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Race (NIH/OMB) |
|
| Region of Enrollment | participants |
|
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.
|
| Secondary | Eye Movement Tracking: Movements to First Saccades | Change from baseline eye movement tracking results at 8 weeks. | No data was collected or analyzed | Posted | 8 weeks |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided