COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu
Trial record 2 of 28 for:    terazosin

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00449683
Recruitment Status : Completed
First Posted : March 20, 2007
Last Update Posted : August 25, 2016
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Thomas Jefferson University

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.

Condition or disease Intervention/treatment Phase
Hyperhidrosis Drug: terazosin Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antidepressant Induced Excessive Sweating: Measurement and Treatment With Terazosin
Study Start Date : March 2007
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: terazosin
open-label treatment group
Drug: terazosin
off-label use of terazosin to treat antidepressant-induced sweating
Other Name: Hytrin

Primary Outcome Measures :
  1. To study whether terazosin 1 to 4 mg/ day is effective in reducing antidepressant-induced sweating [ Time Frame: 8 weeks ]
  2. 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 Measures :
  1. To determine if the severity of sweating at baseline is correlated with baseline urinary norepinephrine levels [ Time Frame: 8 weeks ]
  2. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00449683

Layout table for location information
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
Layout table for investigator information
Principal Investigator: Rajnish Mago, MD Thomas Jefferson University

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Thomas Jefferson University Identifier: NCT00449683    
Other Study ID Numbers: 06F.275
First Posted: March 20, 2007    Key Record Dates
Last Update Posted: August 25, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
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:
Layout table for 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