Efficacy of Exercise for Sexual Side Effects of Antidepressants

NCT01189825 | Completed

• 2 other identifiers: 2007-12-00591F31MH085416-01A1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sexual Dysfunction

Keywords

Physiological; Antidepressive Agents

Outcome Measures

Primary Outcomes (1)

• Sexual arousal

  Arousal to sexually explicit stimuli will be measured in the laboratory using a vaginal photoplethysmograph.

  5 & 15 minutes post exercise

Study Arms (1)

Exercise

EXPERIMENTAL

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Moderate to intense cardiovascular exercise on a treadmill for 20 minutes

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Links

• Laboratory webpage

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Interventions

Exercise

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Tierney K Ahrold Lorenz, M.A.

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: August 25, 2010
• First Posted: August 27, 2010
• Study Start: June 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: August 1, 2012
• Last Updated: February 27, 2013

Record last verified: 2013-02

Locations

US (1)