Pilot Study of Terazosin in Treatment of Antidepressant Induced Excessive Sweating

Thomas Jefferson University

Status

Completed

Conditions

Antidepressant Induced Excessive Sweating

Treatments

Drug: terazosin

Study type

Interventional

Funder types

Other

Identifiers

NCT00237510

05U.84

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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)