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Pilot Study of Terazosin in Treatment of Antidepressant Induced Excessive Sweating

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: NCT00237510
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : March 5, 2014
Information provided by (Responsible Party):
Thomas Jefferson University

Brief Summary:
This study is based on the hypothesis that terazosin, a blocker of alpha-1 receptors, will be effective in reducing excessive sweating caused by antidepressant treatment, and will have minimal adverse effects.

Condition or disease Intervention/treatment Phase
Antidepressant Induced Excessive Sweating Drug: terazosin Not Applicable

Detailed Description:

Sweating is a common and bothersome side effect of treatment with antidepressants. Most or all antidepressants have been clearly shown to cause excessive sweating. It is unclear to what extent excessive sweating caused by antidepressants becomes less or goes away with time. In many instances, it continues to be a problem even after 6 or more months on the antidepressant.

There is no generally accepted treatment for excessive sweating. This study has been designed to study whether terazosin is effective in reducing antidepressant-induced sweating, and whether it is well-tolerated and acceptable to patients. In addition, secondary objectives of this study are to determine the time taken for patients to respond to terazosin, the usual doses needed for improvement, and the extent of reduction in sweating. This information will not only help doctors in using terazosin for this purpose in their patients, but will help in designing further studies of this treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Efficacy and Tolerability of Terazosin for the Treatment of Antidepressant-Induced Excessive Sweating
Study Start Date : May 2005
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Intervention Details:
  • Drug: terazosin
    Other Name: Hytrin

Primary Outcome Measures :
  1. To study whether terazosin 1 to 5 mg/ day is effective in reducing antidepressant-induced sweating
  2. To determine if terazosin is tolerated and acceptable to patients as a potential treatment for antidepressant-induced sweating

Secondary Outcome Measures :
  1. Determine the time-course of response, the dose-response relationship, and the magnitude of effect of treatment of antidepressant-induced sweating to assist in designing a subsequent double-blind, placebo-controlled study of this treatment.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of a Depressive disorder (Diagnostic and Statistical Manual of Mental Disorders - IV-TR)
  • Presence of excessive sweating by self-report
  • The excessive sweating started after initiation of an antidepressant and, if treatment with the antidepressant was interrupted, did not persist for more than 4 weeks during that interruption
  • Treatment with the antidepressant is deemed to be clinically necessary due to substantial benefit from this antidepressant, and failure to respond to or tolerate an alternative
  • Excessive sweating has persisted for at least 4 weeks prior to baseline assessment
  • The excessive sweating is rated by the patient as at least moderately bothersome.
  • Episodes of excessive sweating occur at least twice a week for last 4 weeks

Exclusion Criteria:

  • Presence of another known disease that could potentially cause excessive sweating
  • Failure to respond to antiadrenergic (reducing activity of the sympathetic nervous system) treatment in the past
  • Blood pressure less than 110 mm Hg systolic at the screening or baseline visits
  • Orthostatic hypotension by history or on assessment at the screening or baseline visits (defined as a decrease of 10 mm Hg or greater after standing for 2 minutes).
  • Current antihypertensive treatment
  • History of significant cardiac disease, including coronary artery disease
  • Current use of phosphodiesterase type 5 inhibitors: sildenafil (Viagra™), tadalafil (CialisTM), or vardenafil (LevitraTM)
  • History of priapism (persistent and painful erection)

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): NCT00237510

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United States, Pennsylvania
Thomas Jefferson University Department of Psychiatry and Human Behavior
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
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Principal Investigator: Rajnish Mago, MD Thomas Jefferson University Department of Psychiatry and Human Behavior
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Thomas Jefferson University Identifier: NCT00237510    
Other Study ID Numbers: 05U.84
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014
Keywords provided by Thomas Jefferson University:
Antidepressant induced excessive sweating
Additional relevant MeSH terms:
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Sweat Gland Diseases
Skin Diseases
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents