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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05685407
Enrollment
20
Registered
2023-01-17
Start date
2023-01-01
Completion date
2023-04-15
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female Sexual Arousal Disorder

Keywords

female sexual dysfunction, female sexual arousal disorder, caffeine

Brief summary

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.

Interventions

DRUGCaffeine

300mg caffeine will be administered orally via capsules to participants with female sexual arousal disorder.

OTHERPlacebo

A placebo pill that matches in size, shape, and color will be administered to participants with female sexual arousal disorder.

Sponsors

University of Texas at Austin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Vaginal pulse amplitude via vaginal photoplethysmography15 minutes post-ingestion of caffeine and placeboVaginal pulse amplitude reflects phasic changes in vaginal engorgement with each heart beat, where higher amplitudes indicate higher levels of blood flow

Secondary

MeasureTime frameDescription
Subjective sexual arousal via Heiman and Rowland's (1983) Film Scale30 minutes post-ingestion of caffeine and placeboDiscrete 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026