Efficacy of Exercise for Sexual Side Effects of Antidepressants

Sexual Dysfunction Clinical Trial

Official title:

Effects of Acute Exercise on Sexual Arousal in Women Taking a Selective Serotonin Reuptake Inhibitor (SSRI) or Selective Serotonin/Norepinephrine Reuptake Inhibitor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01189825
• Other study ID #: 2007-12-0059
• Secondary ID: 1F31MH085416-01A
• Status: Completed
• Phase: N/A
• First received: August 25, 2010
• Last updated: February 25, 2013
• Start date: June 2009
• Est. completion date: August 2012

Study information

• Verified date: February 2013
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The major aim of the this study is to replicate findings of previous research that examined the effects of acute exercise on sexual arousal in women in a novel population, namely, women taking antidepressants of the selective serotonin reuptake inhibitors (SSRI) or selective serotonin and norepinephrine reuptake inhibitors (SNRI) class. In previous studies it has been found that acute, moderate-intensity exercise facilitated physiological sexual arousal responses in healthy, sexually functional women. However, it is known that antidepressants may induce sexual dysfunction, and thus in the present study, the investigators are examining whether acute exercise may facilitate sexual responses in women with taking antidepressants, including women with antidepressant-related sexual dysfunction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• female

• age 18 or older

• currently receiving a consistent dosage of escitalopram, citalopram, sertraline, desvenlafaxine, venlafaxine, or duloxetine

• currently sexually active

• willing and able to exercise

• experiencing regular menstrual cycles

• not currently pregnant and not intending to become pregnant during trial

Exclusion Criteria:

• currently taking more than one psychoactive medication

• factors indicating risk of cardiovascular activity, including acute or chronic cardiovascular illness, including clinically significant hypertension (defined as self-reported hypertension or "blood pressure greater than 140/90" or receiving medications designed to treat hypertension); recent chest pain; frequent or recurrent faint or dizzy spells; severe or untreated exercise-related asthma; or musculoskeletal illness or injury that would be expected to worsen with physical exercise. Additionally, women will be excluded if they are found to have any of the following as measured during the fitness assessment of the first session: a BMI over 40, waist circumference over 40 inches, waist-to-hip ratio of greater than 0.9, systolic blood pressure greater than 150 or diastolic pressure over 95, or resting heart rate over 90.

• factors associated with significant genital nerve damage, including: previous major pelvic surgery that may have caused nerve damage, including hysterectomy, vulvectomy, circumcision, colostomy, cystostomy, or serious bladder, rectal, or abdominal surgery; or neurological impairment due to diabetes, stroke, pelvic nerve damage secondary to trauma, cancer treatments, myasthenia gravis, multiple sclerosis or spinal cord damage.

• factors associated with non-normative endocrine function, including: perimenopausal or menopausal status, or >1 missed menstrual period in the previous 6 months; or currently pregnant, breastfeeding, or having breastfed within the past 3 months; or reporting clinically significant untreated renal or endocrine disease

• untreated serious mental health conditions

• sexual aversion or distress due to history of unwanted sexual contact

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Sexual Dysfunction

Intervention

Behavioral:
• Exercise
Moderate to intense cardiovascular exercise on a treadmill for 20 minutes

Locations

Country	Name	City	State
United States	University of Texas at Austin	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas at Austin	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual arousal	Arousal to sexually explicit stimuli will be measured in the laboratory using a vaginal photoplethysmograph.	5 & 15 minutes post exercise	No

External Links

•   Laboratory webpage