HyperhidrosisPhase 4ADIESNCT00449683
Excessive Sweating Caused by Antidepressants: Measurement and Treatment With Terazosin
A Phase 4 study testing terazosin in people with Hyperhidrosis, run by Thomas Jefferson University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperhidrosis
- What is being tested?
- terazosin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Aug 2013
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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 (ViagraTM), 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
Philadelphia, Pennsylvania, 19107
About this study
Official title: Antidepressant Induced Excessive Sweating: Measurement and Treatment With Terazosin
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.
- Conditions
- Hyperhidrosis
- Being tested
- terazosin
- Keywords
- Depressive Disorders, Excessive Sweating, Sweating caused by antidepressants for those a depressive disorder
- Medical subject headings
- Hyperhidrosis, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
terazosinDrug
Also called Hytrin
off-label use of terazosin to treat antidepressant-induced sweating
| Study group | Role | What they receive |
|---|---|---|
| terazosin | Experimental | open-label treatment group Receives: Drug: terazosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study whether terazosin 1 to 4 mg/ day is effective in reducing antidepressant-induced sweating
Measured: 8 weeks
To test a novel device for ambulatory monitoring of sweating which is required to study this phenomenon since ADIES is usually episodic
Measured: 8 weeks
Secondary outcomes (2)
To determine if the severity of sweating at baseline is correlated with baseline urinary norepinephrine levels
Measured: 8 weeks
To determine if response to treatment correlated with baseline urinary norepinephrine levels and with changes in these levels during the study.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionAug 2013
- Study completionAug 2013
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 HyperhidrosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Responsible party
- Sponsor
- Investigators
- Rajnish Mago, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449683
- Sponsor's protocol ID
- 06F.275
- Acronym
- ADIES
- Status last verified
- Aug 2016
- First submitted
- 19 Mar 2007
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antidepressant Induced Excessive Sweating: Measurement and Treatment With Terazosin
- ClinicalTrials.gov ID
- NCT00449683
- Acronym / sponsor ID
- ADIES / 06F.275
- Conditions
- Hyperhidrosis
- Keywords
- Depressive Disorders, Excessive Sweating, Sweating caused by antidepressants for those a depressive disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Study start
- Mar 2007
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 20 Mar 2007 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| terazosin | Experimental | Drug: terazosinopen-label treatment group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
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: Hytrinoff-label use of terazosin to treat antidepressant-induced sweating | Drug | terazosin |
Primary outcome
To study whether terazosin 1 to 4 mg/ day is effective in reducing antidepressant-induced sweating
Time frame: 8 weeks
To test a novel device for ambulatory monitoring of sweating which is required to study this phenomenon since ADIES is usually episodic
Time frame: 8 weeks
2 secondary outcomes
To determine if the severity of sweating at baseline is correlated with baseline urinary norepinephrine levels
Time frame: 8 weeks
To determine if response to treatment correlated with baseline urinary norepinephrine levels and with changes in these levels during the study.
Time frame: 8 weeks
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 25 Aug 2016.
- 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.
- Individual participant dataSharing planned: Undecided
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing terazosin in people with Hyperhidrosis, 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 8 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 25 Aug 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 4 mg/ day is effective in reducing antidepressant-induced sweating (time frame: 8 weeks). 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 NCT00449683, 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 25 Aug 2016.