Examining Caffeine as a Treatment for Antidepressant-induced Arousal Dysfunction in Women

Study Overview
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Brief Summary
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Antidepressants have negative effects on genital arousal function that hinder quality of life and jeopardize medication adherence. Moderate sympathetic nervous system (SNS) activation through exercise has shown promising results for improving antidepressant-induced genital arousal dysfunction. It is feasible that caffeine - an SNS stimulant - could improve antidepressant-induced genital arousal difficulties if ingested prior to sex. The goal of the present pilot study is to examine whether the acute administration of 300mg of caffeine increases genital arousal in women experiencing antidepressant-induced genital arousal difficulties. Women will attend two counterbalanced sessions in which they ingest either 300mg caffeine or placebo. Fifteen minutes after ingestion, they will view an erotic film while their heart rate and genital sexual arousal are measured. Caffeine could serve as a low-cost, widely accessible intervention with minimal side effects if efficacy is shown.

Official Title
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Examining Caffeine as a Treatment for Antidepressant-induced Arousal Dysfunction in Women

Conditions
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Female Sexual Arousal Disorder

Intervention / Treatment
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* Drug: Caffeine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between the of ages 18-55 Fluent in English Experience antidepressant-induced arousal difficulties Experience regular menstrual periods (i.e., not perimenopausal or menopausal) Exclusion Criteria: A history or current diagnosis of panic attacks or panic disorder A history or current diagnosis of sexually transmitted disease(s) A history of major pelvic surgery that caused nerve damage Currently taking beta blockers, antipsychotics, anti-anxiolytics, hormonal contraceptives (unless the participant has been taking it for over 3 months), or any other medical treatment to enhance sexual response Other medical conditions or procedures that would preclude the participant's participation in the study (e.g., urinary tract infection, neurological impairment due to diabetes or stroke, or spinal cord damage) A history of childhood sexual abuse (CSA) that occurred prior to age 16

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caffeine<br>During one of two counterbalanced experimental sessions, participants will ingest 300mg of caffeine orally via capsules. | Drug: Caffeine<br>* 300mg caffeine will be administered orally via capsules to participants with female sexual arousal disorder.<br>|
| Placebo Comparator: Placebo<br>During one of two counterbalanced experimental sessions, participants will ingest placebo orally via capsules. | Other: Placebo<br>* A placebo pill that matches in size, shape, and color will be administered to participants with female sexual arousal disorder.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal pulse amplitude via vaginal photoplethysmography | Vaginal pulse amplitude reflects phasic changes in vaginal engorgement with each heart beat, where higher amplitudes indicate higher levels of blood flow | 15 minutes post-ingestion of caffeine and placebo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective sexual arousal via Heiman and Rowland's (1983) Film Scale | Discrete measurement of the construct was calculated by summing the scores of the three original subjective sexual arousal items from Heiman and Rowland's (1983) Film Scale, which assesses sexual arousal as well as positive and negative affect in response to an erotic film. These three items include an assessment of overall sexual arousal, a sense of mental sexual arousal, and one reverse-scored item on feeling sexually turned off. On two occasions during the experiment (immediately following the first neutral-erotic film sequence and immediately following the second neutral-erotic film sequence), participants rated the degree to which they experienced each of the three items on a 7-point Likert scale (where higher scores indicate higher subjective sexual arousal), and then the three scores were combined into a single subjective sexual arousal score for each of the two time points. | 30 minutes post-ingestion of caffeine and placebo | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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female sexual dysfunction, female sexual arousal disorder, caffeine