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

Antidepressant Induced Excessive Sweating: Measurement and Treatment With Terazosin

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.

Study Overview

• Status: Completed
• Conditions: Hyperhidrosis
• Intervention / Treatment: Drug: terazosin

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University, Department of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: terazosin; open-label treatment group	Drug: terazosin; off-label use of terazosin to treat antidepressant-induced sweating; Other Names: Hytrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To study whether terazosin 1 to 4 mg/ day is effective in reducing antidepressant-induced sweating	8 weeks
To test a novel device for ambulatory monitoring of sweating which is required to study this phenomenon since ADIES is usually episodic	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine if the severity of sweating at baseline is correlated with baseline urinary norepinephrine levels	8 weeks
To determine if response to treatment correlated with baseline urinary norepinephrine levels and with changes in these levels during the study.	8 weeks

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Collaborators: National Alliance for Research on Schizophrenia and Depression
• Investigators: Principal Investigator: Rajnish Mago, MD, Thomas Jefferson University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: March 19, 2007
• First Submitted That Met QC Criteria: March 19, 2007
• First Posted (Estimate): March 20, 2007

Study Record Updates

• Last Update Posted (Estimate): August 25, 2016
• Last Update Submitted That Met QC Criteria: August 24, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Depressive Disorders; Excessive Sweating; Sweating caused by antidepressants for those a depressive disorder
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Terazosin
• Other Study ID Numbers: 06F.275

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided