Efficacy Study Measuring The Impact Of Treatment With Viagra On The Depressive Symptoms Of Men With Erectile Dysfunction
Status and phase
Completed
Phase 4
Conditions
Impotence
Depression
Treatments
Drug: Viagra (Sildenafil citrate)
Details and patient eligibility
About
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.
Sex
Male
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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