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

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00449683
First received: March 19, 2007
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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 antidressant 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
Hyperhidrosis
Drug: terazosin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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
  • 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.

Estimated Enrollment: 20
Study Start Date: March 2007
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00449683

Locations
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
Investigators
Principal Investigator: Rajnish Mago, MD Thomas Jefferson University
  More Information

No publications provided by Thomas Jefferson University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00449683     History of Changes
Other Study ID Numbers: 06F.275
Study First Received: March 19, 2007
Last Updated: February 24, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hyperhidrosis
Sweat Gland Diseases
Skin Diseases
Antidepressive Agents
Terazosin
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014