NCT05685407

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Texas at Austin · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Female Sexual Arousal Disorder

Interventions

Type	Name	Description
DRUG	Caffeine	300mg caffeine will be administered orally via capsules to participants with female sexual arousal disorder.
OTHER	Placebo	A placebo pill that matches in size, shape, and color will be administered to participants with female sexual arousal disorder.

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-04-15
• Completion: 2023-04-15
• First posted: 2023-01-17
• Last updated: 2023-06-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study