Excessive Sweating Caused by Antidepressants: Measurement and Treatment With Terazosin
Information source: Thomas Jefferson University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperhidrosis
Intervention: terazosin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Thomas Jefferson University Official(s) and/or principal investigator(s): Rajnish Mago, MD, Principal Investigator, Affiliation: Thomas Jefferson University
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 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.
Clinical Details
Official title: Antidepressant Induced Excessive Sweating: Measurement and Treatment With Terazosin
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To study whether terazosin 1 to 4 mg/ day is effective in reducing antidepressant-induced sweatingTo test a novel device for ambulatory monitoring of sweating which is required to study this phenomenon since ADIES is usually episodic
Secondary outcome: To determine if the severity of sweating at baseline is correlated with baseline urinary norepinephrine levelsTo determine if response to treatment correlated with baseline urinary norepinephrine levels and with changes in these levels during the study.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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)
Locations and Contacts
Thomas Jefferson University, Department of Psychiatry, Philadelphia, Pennsylvania 19107, United States
Additional Information
Starting date: March 2007
Last updated: June 3, 2014
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