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

This study has been completed.
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Thomas Jefferson University Identifier:
First received: March 19, 2007
Last updated: August 24, 2016
Last verified: August 2016
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.

Condition Intervention Phase
Drug: terazosin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Antidepressant Induced Excessive Sweating: Measurement and Treatment With Terazosin

Resource links provided by NLM:

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • To study whether terazosin 1 to 4 mg/ day is effective in reducing antidepressant-induced sweating [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine if the severity of sweating at baseline is correlated with baseline urinary norepinephrine levels [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: March 2007
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: terazosin
open-label treatment group
Drug: terazosin
off-label use of terazosin to treat antidepressant-induced sweating
Other Name: Hytrin


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00449683

United States, Pennsylvania
Thomas Jefferson University, Department of Psychiatry
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
National Alliance for Research on Schizophrenia and Depression
Principal Investigator: Rajnish Mago, MD Thomas Jefferson University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Thomas Jefferson University Identifier: NCT00449683     History of Changes
Other Study ID Numbers: 06F.275 
Study First Received: March 19, 2007
Last Updated: August 24, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Thomas Jefferson University:
Depressive Disorders
Excessive Sweating
Sweating caused by antidepressants for those a depressive disorder

Additional relevant MeSH terms:
Sweat Gland Diseases
Skin Diseases
Antidepressive Agents
Psychotropic Drugs
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Antihypertensive Agents processed this record on October 21, 2016