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Pilot Study of Terazosin in Treatment of Antidepressant Induced Excessive Sweating

Primary Purpose

Antidepressant Induced Excessive Sweating

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
terazosin
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Antidepressant Induced Excessive Sweating focused on measuring Antidepressant induced excessive sweating

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Thomas Jefferson University Department of Psychiatry and Human Behavior

Outcomes

Primary Outcome 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 Outcome 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.

Full Information

First Posted
October 11, 2005
Last Updated
March 4, 2014
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT00237510
Brief Title
Pilot Study of Terazosin in Treatment of Antidepressant Induced Excessive Sweating
Official Title
A Pilot Study of the Efficacy and Tolerability of Terazosin for the Treatment of Antidepressant-Induced Excessive Sweating
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antidepressant Induced Excessive Sweating
Keywords
Antidepressant induced excessive sweating

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
terazosin
Other Intervention Name(s)
Hytrin
Primary Outcome Measure Information:
Title
To study whether terazosin 1 to 5 mg/ day is effective in reducing antidepressant-induced sweating
Title
To determine if terazosin is tolerated and acceptable to patients as a potential treatment for antidepressant-induced sweating
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajnish Mago, MD
Organizational Affiliation
Thomas Jefferson University Department of Psychiatry and Human Behavior
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University Department of Psychiatry and Human Behavior
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23638448
Citation
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.
Results Reference
derived

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Pilot Study of Terazosin in Treatment of Antidepressant Induced Excessive Sweating

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