Sexual Health on Antidepressants Through Physical Exercise

NCT ID: NCT01188720

Last Updated: 2015-05-27

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-08-31

Brief Summary

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Preliminary findings from a trial in the investigators laboratory suggest that acute exercise may ameliorate deficits in sexual arousal associated with use of antidepressants. The goal of this project is to evaluate the real-world effectiveness of an exercise-based intervention for these side effects in a community-based sample. The investigators hypothesize that general exercise will help improve sexual functioning in women taking antidepressants, and that exercise immediately before sexual activity - that is, acute exercise - will have an additional beneficial effect above and beyond that of general exercise.

Detailed Description

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Conditions

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Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Baseline

Assessment only baseline

Group Type NO_INTERVENTION

No interventions assigned to this group

Acute exercise

Exercise immediately before sexual activity, three times per week.

Group Type EXPERIMENTAL

Physical activity

Intervention Type BEHAVIORAL

30 minutes of moderate to intense physical activity including strength training and cardiovascular activity.

General exercise

Exercise not immediately before sexual activity, three times per week.

Group Type ACTIVE_COMPARATOR

Physical activity

Intervention Type BEHAVIORAL

30 minutes of moderate to intense physical activity including strength training and cardiovascular activity.

Interventions

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Physical activity

30 minutes of moderate to intense physical activity including strength training and cardiovascular activity.

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 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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F31MH085416

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2010-07-0043

Identifier Type: -

Identifier Source: org_study_id

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