Official Title: “A Pilot Study of the Efficacy and Tolerability of Terazosin for the Treatment of Antidepressant-Induced Excessive Sweating”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: terazosin

Primary 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 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.

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Thomas Jefferson University

Overall Clinical Trial Officials and Contacts

Rajnish Mago, MD Principal Investigator Thomas Jefferson University Department of Psychiatry and Human Behavior  

Overall Contact: Shannon Duffany, B.A. 215-503-1662 shannon.duffany@jefferson.edu

Information obtained from ClinicalTrials.gov on October 06, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00237510

Study ID Number: 05U.84

ClinicalTrials.gov Identifier: NCT00237510

Health Authority: United States: Food and Drug Administration