Investigation of brain processing in Hypoactive Sexual Desire Disorder Mental and Behavioural Disorders Hypoactive Sexual Desire Disorder
Conditions
Interventions
Randomised, double-blinded, two-way crossover study comparing the effects of a 75-minute intravenous infusion of kisspeptin at 1 nmol/kg/hour versus vehicle (rate-matched intravenous infusion of Gelof
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 – 70 years (men) 2. Aged >18 years and pre-menopausal (women) 3. Right handed 4. Non-smoker 5. Heterosexual orientation 6. Low sexual desire, meeting the DSM-5 criteria for Hypoactive Sexual Desire Disorder 7. Free of current or past physical or psychiatric illness 8. Naive to psychoactive substances, prescribed or illicit, for a minimum of 6 months prior to screening. 9. Normal or corrected-to-normal vision. 10. Absence of a history of sexual aggression/abuse/phobia or psychotherapy/counselling
Exclusion criteria
Exclusion criteria: 1. History of any medical, psychological or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study or potentially cause harm to the participant 2. Medical or psychological conditions that would impair their ability to participate reliably in the study or give informed consent 3. Pregnancy and/or breastfeeding 4. Post-menopausal (female) 5. Any implanted material in the body that would preclude magnetic resonance imaging (MRI) for safety reasons 6. Inability to tolerate MRI scanning 7. Without access at home to a telephone, or other factor likely to interfere with ability to participate reliably in the study 8. History of hypersensitivity to any of the components administered 9. Treatment with an investigational drug within the preceding two months 10. Those who have or intend to donate blood or blood products within three months before or following study completion 11. A history of major haematological, renal, thyroid or hepatic abnormalities or significant cardiovascular disease 12. A history of cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sexual and emotional brain processing during validated fMRI tasks (such as male/female facial images and erotic videos), as determined by the change in fMRI blood oxygen level dependent (BOLD) activity measured once in each infusion condition | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured during intravenous infusion of kisspeptin or vehicle: 1. Hormone and biochemical concentrations, including levels of luteinising hormone, follicle-stimulating hormone, kisspeptin, oestradiol, testosterone, measured every 15-minutes using a blood sample 2. Psychometric measure of motivation determined using the Behavioral Inhibition/Activation System Scale 3. Psychometric measure of sexual arousal and desire determined using the Sexual Arousal & Desire Inventory 4. Psychometric measure of mood determined using the Positive and Negative Affect Schedule 5. Psychometric measure of anxiety and attention determined using the State-Trait Anxiety Inventory and D2 Test of Attention 6. Physical measures of sexual arousal and safety, including blood pressure (sphygmomanometer) and heart rate (pulse oximeter) | — |
Countries
England, United Kingdom
Contacts
Public ContactEdouard Mills
Outcome results
None listed