Clinical trial

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

Name
00002778
Description
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.
Trial arms
Trial start
2023-01-01
Estimated PCD
2023-04-15
Trial end
2023-04-15
Status
Completed
Phase
Early phase I
Treatment
Caffeine
300mg caffeine will be administered orally via capsules to participants with female sexual arousal disorder.
Arms:
Caffeine
Placebo
A placebo pill that matches in size, shape, and color will be administered to participants with female sexual arousal disorder.
Arms:
Placebo
Size
20
Primary endpoint
Vaginal pulse amplitude via vaginal photoplethysmography
15 minutes post-ingestion of caffeine and placebo
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}
Updated at
2023-06-22

1 organization

1 product

1 indication

Product
Caffeine