Pilot Study of Terazosin in Treatment of Antidepressant Induced Excessive Sweating

NCT00237510 | Completed DMC

• 1 other identifier: 05U.84
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Antidepressant Induced Excessive Sweating

Keywords

Antidepressant induced excessive sweating

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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.

Interventions

terazosin DRUG

Also known as: Hytrin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Department of Psychiatry and Human Behavior

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• Mago R, Thase ME, Rovner BW. Antidepressant-induced excessive sweating: clinical features and treatment with terazosin. Ann Clin Psychiatry. 2013 Aug;25(3):186-92. Epub 2013 May 1.

  PMID: 23638448 DERIVED

MeSH Terms

Interventions

Terazosin

Study Officials

• Rajnish Mago, MD

  Thomas Jefferson University Department of Psychiatry and Human Behavior

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2005
• First Posted: October 12, 2005
• Study Start: May 1, 2005
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2007
• Last Updated: March 5, 2014

Record last verified: 2014-03

Locations

US (1)