NCT00449683

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2007

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 25, 2016

Status Verified

August 1, 2016

Enrollment Period

6.4 years

First QC Date

March 19, 2007

Last Update Submit

August 24, 2016

Conditions

Hyperhidrosis

Keywords

Depressive DisordersExcessive SweatingSweating caused by antidepressants for those a depressive disorder

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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

Study Arms (1)

terazosin

EXPERIMENTAL

open-label treatment group

Drug: terazosin

Interventions

terazosinDRUG

off-label use of terazosin to treat antidepressant-induced sweating

Also known as: Hytrin
terazosin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University, Department of Psychiatry

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • 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.

    PMID: 23638448DERIVED

MeSH Terms

Conditions

HyperhidrosisDepressive Disorder

Interventions

Terazosin

Condition Hierarchy (Ancestors)

Sweat Gland DiseasesSkin DiseasesSkin and Connective Tissue DiseasesMood DisordersMental Disorders

Study Officials

  • Rajnish Mago, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2007

First Posted

March 20, 2007

Study Start

March 1, 2007

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

August 25, 2016

Record last verified: 2016-08

Locations

US(1)