Status:
COMPLETED
Excessive Sweating Caused by Antidepressants: Measurement and Treatment With Terazosin
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
National Alliance for Research on Schizophrenia and Depression
Conditions:
Hyperhidrosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 antid...
Eligibility Criteria
Inclusion
- Age 18 - 75 years
- 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
- 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 (ViagraTM), tadalafil (CialisTM), or vardenafil (LevitraTM)
- History of priapism (persistent and painful erection)
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00449683
Start Date
March 1 2007
End Date
August 1 2013
Last Update
August 25 2016
Active Locations (1)
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1
Thomas Jefferson University, Department of Psychiatry
Philadelphia, Pennsylvania, United States, 19107