Antidepressant Induced Excessive SweatingNCT00237510
Pilot Study of Terazosin in Treatment of Antidepressant Induced Excessive Sweating
A study testing terazosin in people with Antidepressant Induced Excessive Sweating, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This study is based on the hypothesis that terazosin, a blocker of alpha-1 receptors, will be effective in reducing excessive sweating caused by antidepressant treatment, and will have minimal adverse effects. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Antidepressant Induced Excessive Sweating
- What is being tested?
- terazosin
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to May 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Department of Psychiatry and Human Behavior
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Pilot Study of the Efficacy and Tolerability of Terazosin for the Treatment of Antidepressant-Induced Excessive Sweating
This study is based on the hypothesis that terazosin, a blocker of alpha-1 receptors, will be effective in reducing excessive sweating caused by antidepressant treatment, and will have minimal adverse effects.
Read the 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.
- Being tested
- terazosin
- Keywords
- Antidepressant induced excessive sweating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
terazosinDrug
Also called Hytrin
What is being measured
The primary outcome is the main question the study is designed to answer.
To study whether terazosin 1 to 5 mg/ day is effective in reducing antidepressant-induced sweating
To determine if terazosin is tolerated and acceptable to patients as a potential treatment for antidepressant-induced sweating
Secondary outcomes (1)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startMay 2005
- Primary completionMay 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antidepressant Induced Excessive SweatingStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rajnish Mago, MD, Principal investigator, Thomas Jefferson University Department of Psychiatry and Human Behavior
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237510
- Sponsor's protocol ID
- 05U.84
- Status last verified
- Mar 2014
- First submitted
- 11 Oct 2005
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23638448
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Efficacy and Tolerability of Terazosin for the Treatment of Antidepressant-Induced Excessive Sweating
- ClinicalTrials.gov ID
- NCT00237510
- Acronym / sponsor ID
- 05U.84
- Keywords
- Antidepressant induced excessive sweating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 12 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is based on the hypothesis that terazosin, a blocker of alpha-1 receptors, will be effective in reducing excessive sweating caused by antidepressant treatment, and will have minimal adverse effects.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| terazosinAlso: Hytrin | Drug | – |
Primary outcome
To study whether terazosin 1 to 5 mg/ day is effective in reducing antidepressant-induced sweating
To determine if terazosin is tolerated and acceptable to patients as a potential treatment for antidepressant-induced sweating
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2014.
- Derived from this study: PubMed 23638448Mago 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajnish Mago, MD principal investigator
Thomas Jefferson University Department of Psychiatry and Human Behavior
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing terazosin in people with Antidepressant Induced Excessive Sweating, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study whether terazosin 1 to 5 mg/ day is effective in reducing antidepressant-induced sweating. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00237510, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2014.