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Excessive Sweating Caused by Antidepressants: Measurement and Treatment With Terazosin (ADIES)

Primary Purpose

Hyperhidrosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
terazosin
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperhidrosis focused on measuring Depressive Disorders, Excessive Sweating, Sweating caused by antidepressants for those a depressive disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age 18 - 75 years
  2. Clinical diagnosis of a Depressive disorder (Diagnostic and Statistical Manual of Mental Disorders - IV-TR)
  3. Presence of excessive sweating by self-report
  4. 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
  5. 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
  6. Excessive sweating has persisted for at least 4 weeks prior to baseline assessment
  7. The excessive sweating is rated by the patient as at least moderately bothersome.
  8. Episodes of excessive sweating occur at least twice a week for last 4 weeks

Exclusion Criteria:

  1. Presence of another known disease that could potentially cause excessive sweating
  2. Failure to respond to antiadrenergic (reducing activity of the sympathetic nervous system) treatment in the past
  3. Blood pressure less than 110 mm Hg systolic at the screening or baseline visits
  4. 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).
  5. Current antihypertensive treatment
  6. History of significant cardiac disease, including coronary artery disease
  7. Current use of phosphodiesterase type 5 inhibitors: sildenafil (ViagraTM), tadalafil (CialisTM), or vardenafil (LevitraTM)
  8. History of priapism (persistent and painful erection)

Sites / Locations

  • Thomas Jefferson University, Department of Psychiatry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

terazosin

Arm Description

open-label treatment group

Outcomes

Primary Outcome Measures

To study whether terazosin 1 to 4 mg/ day is effective in reducing antidepressant-induced sweating
To test a novel device for ambulatory monitoring of sweating which is required to study this phenomenon since ADIES is usually episodic

Secondary Outcome Measures

To determine if the severity of sweating at baseline is correlated with baseline urinary norepinephrine levels
To determine if response to treatment correlated with baseline urinary norepinephrine levels and with changes in these levels during the study.

Full Information

First Posted
March 19, 2007
Last Updated
August 24, 2016
Sponsor
Thomas Jefferson University
Collaborators
National Alliance for Research on Schizophrenia and Depression
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1. Study Identification

Unique Protocol Identification Number
NCT00449683
Brief Title
Excessive Sweating Caused by Antidepressants: Measurement and Treatment With Terazosin
Acronym
ADIES
Official Title
Antidepressant Induced Excessive Sweating: Measurement and Treatment With Terazosin
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
Collaborators
National Alliance for Research on Schizophrenia and Depression

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study consists of measurement of antidepressant-induced excessive sweating and its treatment with an experimental medication, terazosin (approved for hypertension), that will be added to the antidepressant. This study is for people who take an antidepressant due to a depressive disorder. This is an open-label study (no placebo group) that will last 5 weeks, with one week of baseline measurement and four weeks of treatment with the study medication. The study is based on the hypothesis that terazosin will be effective in reducing the severity of excessive sweating caused by antidepressant treatment, and will have minimal side-effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis
Keywords
Depressive Disorders, Excessive Sweating, Sweating caused by antidepressants for those a depressive disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
terazosin
Arm Type
Experimental
Arm Description
open-label treatment group
Intervention Type
Drug
Intervention Name(s)
terazosin
Other Intervention Name(s)
Hytrin
Intervention Description
off-label use of terazosin to treat antidepressant-induced sweating
Primary Outcome Measure Information:
Title
To study whether terazosin 1 to 4 mg/ day is effective in reducing antidepressant-induced sweating
Time Frame
8 weeks
Title
To test a novel device for ambulatory monitoring of sweating which is required to study this phenomenon since ADIES is usually episodic
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
To determine if the severity of sweating at baseline is correlated with baseline urinary norepinephrine levels
Time Frame
8 weeks
Title
To determine if response to treatment correlated with baseline urinary norepinephrine levels and with changes in these levels during the study.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 - 75 years 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 (ViagraTM), 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
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University, Department of Psychiatry
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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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Excessive Sweating Caused by Antidepressants: Measurement and Treatment With Terazosin

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