Efficacy of Exercise for Sexual Side Effects of Antidepressants

February 25, 2013 updated by: Tierney Kyle Ahrold Lorenz, University of Texas at Austin

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78712
        • University of Texas at Austin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Exercise
Behavioral: Exercise
Moderate to intense cardiovascular exercise on a treadmill for 20 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual arousal
Time Frame: 5 & 15 minutes post exercise
Arousal to sexually explicit stimuli will be measured in the laboratory using a vaginal photoplethysmograph.
5 & 15 minutes post exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Tierney K Ahrold Lorenz, M.A., University of Texas at Austin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ACTUAL)

May 1, 2011

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

August 25, 2010

First Submitted That Met QC Criteria

August 26, 2010

First Posted (ESTIMATE)

August 27, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 27, 2013

Last Update Submitted That Met QC Criteria

February 25, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2007-12-0059
  • 1F31MH085416-01A1 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sexual Dysfunction

Clinical Trials on Exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe