Efficacy Study Measuring The Impact Of Treatment With Viagra On The Depressive Symptoms Of Men With Erectile Dysfunction

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.140 enrolled

Overview

This study will measure the impact of treatment with Viagra on the depressive symptoms and quality of life in men with erectile dysfunction who have untreated depressive symptoms meeting the DSM-IV criteria for dysthymia or depression not otherwise specified (NOS), including minor depressive symptoms but excluding any form of psychotic disorder.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

140

Conditions

Impotence Depression

Interventions

Viagra (Sildenafil citrate)DRUG

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men above age of majority with ED (SHIM score less than 21) * Beck Depression Inventory II score between 14 and 28 Exclusion Criteria: * Subjects with symptoms of mania or major depressive disorders as demonstrated by the Mini International Neuropsychiatric Interview (MINI) * Subjects who require treatment with antipsychotics, mood stabilizers, antidepressant agents or lithium (concomitant use of benzodiazepines is allowed) or who has required treatment with any of the above medication within the past 3 months

Outcomes

Primary Outcomes

Describe the effect of treatment with sildenafil on the depressive symptoms in subjects with ED as measured by the BDI II at the end of the double-blind phase

Secondary Outcomes

Measure QoL improvement; Describe treatment effect on social motivation & behavior; Describe relationship between depression severity and ED; Describe effectiveness of sildenafil; Describe correlation between the SEX FX and the IIEF; Validate the PREFA

Data from ClinicalTrials.gov

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