Pilot Study of Terazosin in Treatment of Antidepressant Induced Excessive Sweating

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00237510
First received: October 11, 2005
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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 Intervention
Antidepressant Induced Excessive Sweating
Drug: terazosin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 15
Study Start Date: May 2005
Study Completion Date: May 2007
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: terazosin
    Other Name: Hytrin
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237510

Locations
United States, Pennsylvania
Thomas Jefferson University Department of Psychiatry and Human Behavior
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Rajnish Mago, MD Thomas Jefferson University Department of Psychiatry and Human Behavior
  More Information

No publications provided by Thomas Jefferson University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00237510     History of Changes
Other Study ID Numbers: 05U.84
Study First Received: October 11, 2005
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Thomas Jefferson University:
Antidepressant induced excessive sweating

Additional relevant MeSH terms:
Hyperhidrosis
Sweat Gland Diseases
Skin Diseases
Antidepressive Agents
Terazosin
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on August 28, 2014