Efficacy of Exercise for Sexual Side Effects of Antidepressants

NCT ID: NCT01189825

Last Updated: 2013-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sexual Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Exercise

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Moderate to intense cardiovascular exercise on a treadmill for 20 minutes

Interventions

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Exercise

Moderate to intense cardiovascular exercise on a treadmill for 20 minutes

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Tierney Kyle Ahrold Lorenz

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tierney K Ahrold Lorenz, M.A.

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

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University of Texas at Austin

Austin, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mestonlab.com

Laboratory webpage

Other Identifiers

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1F31MH085416-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2007-12-0059

Identifier Type: -

Identifier Source: org_study_id

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