Excessive Sweating Caused by Antidepressants: Measurement and Treatment With Terazosin

Hyperhidrosis Clinical Trial

— ADIES  

Official title:

Antidepressant Induced Excessive Sweating: Measurement and Treatment With Terazosin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00449683
• Other study ID #: 06F.275
• Status: Completed
• Phase: Phase 4
• First received: March 19, 2007
• Last updated: August 24, 2016
• Start date: March 2007
• Est. completion date: August 2013

Study information

• Verified date: August 2016
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperhidrosis

Intervention

Drug:
• terazosin
off-label use of terazosin to treat antidepressant-induced sweating

Locations

Country	Name	City	State
United States	Thomas Jefferson University, Department of Psychiatry	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	National Alliance for Research on Schizophrenia and Depression

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To study whether terazosin 1 to 4 mg/ day is effective in reducing antidepressant-induced sweating		8 weeks	No
Primary	To test a novel device for ambulatory monitoring of sweating which is required to study this phenomenon since ADIES is usually episodic		8 weeks	No
Secondary	To determine if the severity of sweating at baseline is correlated with baseline urinary norepinephrine levels		8 weeks	No
Secondary	To determine if response to treatment correlated with baseline urinary norepinephrine levels and with changes in these levels during the study.		8 weeks	No