A Combined Psycho-Pharmacological and Brain Imaging Study of Human Sexuality - Full Text View

Sponsors and Collaborators:	Hadassah Medical Organization Ben-Gurion University of the Negev
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00569413

Purpose

The current study combines a molecular genetic perspective, self report and brain imaging to the study of human sexuality in control subjects and individuals from a sexual disorder clinic. The investigators hypothesize that the variability in components of the brain dopaminergic system expressed in the mesolimbic reward system can explain variability in human sexuality, especially in desire and pleasure associated with sex.

Condition
Hypoactive Sexual Desire Disorder Erectile Dysfunction

MedlinePlus related topics: Erectile Dysfunction

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Cross-Sectional
Official Title:	A Combined Psycho-Pharmacological and Brain Imaging Study of Human Sexuality

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

Brain Imaging data of DRD2 receptor occupancy during watching a sex videotape and neutral videotape [ Time Frame: 2 Brain imaging sessions a week apart ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Questionnaire ratings of human sexuality, pleasure, and anticipatory reward [ Time Frame: Taken during brain scans ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	40
Study Start Date:	April 2009
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Healthy control subjects (n=20) age 21-65 who do not suffer from a psychiatric diagnosis or neurological damage, are under age, or are pregnant women
2 20 patients who suffer from sexual disorder (reduced sexual desire or sexual function) from a sexual disorder clinic, age 21-65, without any other psychiatric disorder, neurological damage, are not under age or pregnant women.

Detailed Description:

We intend to combine molecular genetics of the dopamine receptors (D2, D3 D4 and D5) and brain imaging using 11 C Raclopride in Positron Emission Tomography (PET). 11 C Raclopride is a ligand which binds to the dopamine receptor D2 and can measure dopamine release during pleasure or anticipatory reward associated with sex. The current proposal will measure changes in DRD2 receptor occupancy using 11 C Raclopride following explicit visual sexual desire cues in healthy control subjects and individuals who suffer from sexual dysfunction. This is in order to determine how individual genotypes modulate dopamine release in vivo in the human brain.

Eligibility

Ages Eligible for Study:	21 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

A group of healthy volunteers from the general public. A group of patients who suffer from sexual disorder from a primary care clinic.

Criteria

Inclusion Criteria:

Healthy volunteers and patients
Age 21-65
Male or female

Exclusion Criteria:

Psychiatric diagnosis/psychosis
Neurological damage associated with loss of consciousness
Infectious disease HIV
Herpes
Syphilis
Hyperactivity treated with ritalin
Pregnant women
Under age

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569413

Contacts

Contact: Aviv M. Weinstein, Ph.D	00 972 2 6776705	vaviv@hadassa.org.il
Contact: Roland Chisin, M.D	00972 2 6776705	chisin@hadassah.org.il

Sponsors and Collaborators

Hadassah Medical Organization

Ben-Gurion University of the Negev

Investigators

Principal Investigator:

Aviv M Weinstein, Ph.D

Hadasah Medical Organization, Jerusalem Israel

More Information

No publications provided

Responsible Party:	Hadassah Medical Organization ( Prof. Roland Chisin )
Study ID Numbers:	281207HMO-CTIL, First 978[1].07
Study First Received:	December 6, 2007
Last Updated:	February 1, 2009
ClinicalTrials.gov Identifier:	NCT00569413 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:

Sex
brain imaging
dopamine
sexual disorder

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Dopamine
Sexual Dysfunction, Physiological
Mental Disorders

Dopamine Agents
Genital Diseases, Male
Hypokinesia
Erectile Dysfunction

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Mental Disorders

Genital Diseases, Male
Sexual and Gender Disorders
Erectile Dysfunction

ClinicalTrials.gov processed this record on May 06, 2009