Pilot Study of Terazosin in Treatment of Antidepressant Induced Excessive Sweating

Antidepressant Induced Excessive Sweating Clinical Trial

Official title:

A Pilot Study of the Efficacy and Tolerability of Terazosin for the Treatment of Antidepressant-Induced Excessive Sweating

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00237510
• Other study ID #: 05U.84
• Status: Completed
• Phase: N/A
• First received: October 11, 2005
• Last updated: March 4, 2014
• Start date: May 2005
• Est. completion date: May 2007

Study information

• Verified date: March 2014
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2007
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Antidepressant Induced Excessive Sweating
• Hyperhidrosis

Intervention

Drug:
• terazosin

Locations

Country	Name	City	State
United States	Thomas Jefferson University Department of Psychiatry and Human Behavior	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To study whether terazosin 1 to 5 mg/ day is effective in reducing antidepressant-induced sweating
Primary	To determine if terazosin is tolerated and acceptable to patients as a potential treatment for antidepressant-induced sweating
Secondary	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.