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Trial record 70 of 2663 for:    "Depressive Disorder" [DISEASE] AND depressive symptoms

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00159809
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 23, 2008
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Impotence Depression Drug: Viagra (Sildenafil citrate) Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multi-Center, Flexible Dose Study With A Double-Blind, Randomized, Placebo-Controlled Phase Followed By An Open-Label Phase To Evaluate The Impact Of Treatment With Sildenafil Citrate On The Symptoms Of Depression And Quality Of Life (Qol) Of Male Patients With Erectile Dysfunction (ED)
Study Start Date : March 2004
Study Completion Date : August 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00159809

Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Layout table for additonal information Identifier: NCT00159809     History of Changes
Other Study ID Numbers: A1481110
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 23, 2008
Last Verified: January 2008

Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Erectile Dysfunction
Mood Disorders
Mental Disorders
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Citric Acid
Sodium Citrate
Sildenafil Citrate
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents