- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00237510
Pilot Study of Terazosin in Treatment of Antidepressant Induced Excessive Sweating
A Pilot Study of the Efficacy and Tolerability of Terazosin for the Treatment of Antidepressant-Induced Excessive Sweating
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sweating is a common and bothersome side effect of treatment with antidepressants. Most or all antidepressants have been clearly shown to cause excessive sweating. It is unclear to what extent excessive sweating caused by antidepressants becomes less or goes away with time. In many instances, it continues to be a problem even after 6 or more months on the antidepressant.
There is no generally accepted treatment for excessive sweating. This study has been designed to study whether terazosin is effective in reducing antidepressant-induced sweating, and whether it is well-tolerated and acceptable to patients. In addition, secondary objectives of this study are to determine the time taken for patients to respond to terazosin, the usual doses needed for improvement, and the extent of reduction in sweating. This information will not only help doctors in using terazosin for this purpose in their patients, but will help in designing further studies of this treatment.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University Department of Psychiatry and Human Behavior
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of a Depressive disorder (Diagnostic and Statistical Manual of Mental Disorders - IV-TR)
- Presence of excessive sweating by self-report
- 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
- 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
- Excessive sweating has persisted for at least 4 weeks prior to baseline assessment
- The excessive sweating is rated by the patient as at least moderately bothersome.
- Episodes of excessive sweating occur at least twice a week for last 4 weeks
Exclusion Criteria:
- Presence of another known disease that could potentially cause excessive sweating
- Failure to respond to antiadrenergic (reducing activity of the sympathetic nervous system) treatment in the past
- Blood pressure less than 110 mm Hg systolic at the screening or baseline visits
- 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).
- Current antihypertensive treatment
- History of significant cardiac disease, including coronary artery disease
- Current use of phosphodiesterase type 5 inhibitors: sildenafil (Viagra™), tadalafil (CialisTM), or vardenafil (LevitraTM)
- History of priapism (persistent and painful erection)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To study whether terazosin 1 to 5 mg/ day is effective in reducing antidepressant-induced sweating
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To determine if terazosin is tolerated and acceptable to patients as a potential treatment for antidepressant-induced sweating
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Secondary Outcome Measures
Outcome Measure |
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Determine the time-course of response, the dose-response relationship, and the magnitude of effect of treatment of antidepressant-induced sweating to assist in designing a subsequent double-blind, placebo-controlled study of this treatment.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rajnish Mago, MD, Thomas Jefferson University Department of Psychiatry and Human Behavior
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05U.84
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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