Pilot Study of Terazosin in Treatment of Antidepressant Induced Excessive Sweating

Condition(s) targeted: Antidepressant Induced Excessive Sweating

Intervention: terazosin (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Thomas Jefferson University

Official(s) and/or principal investigator(s):
Rajnish Mago, MD, Principal Investigator, Affiliation: Thomas Jefferson University Department of Psychiatry and Human Behavior

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

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.

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

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

Primary outcome:

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: 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.

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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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)

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

Thomas Jefferson University Department of Psychiatry and Human Behavior, Philadelphia, Pennsylvania 19107, United States; Recruiting
Shannon Duffany, B.A., Phone: 215-503-1662, Email: shannon.duffany@jefferson.edu
Rajnish Mago, MD, Principal Investigator

Starting date: May 2005
Last updated: March 30, 2007