Hyperhydrosis | Excessive Sweating Caused by Antidepressants: Measurement and Treatment With Glycopyrrolate (AIDES-G)
Hyperhydrosis research study
What is the primary objective of this study?
The study consists of measurement of antidepressant-induced excessive sweating and its treatment with an experimental medication, glycopyrrolate (approved to treat ulcers), which will be added to the antidepressant. This is an open-label study (no placebo group or concealment of the nature of the treatment) that will last 8 weeks, including two weeks of baseline measurement without treatment with the study medication followed by six weeks of treatment with the study medication. The study is pilot study by Dr. Rajnish Mago that is based on the hypothesis that glycopyrrolate will be effective in reducing the severity of excessive sweating caused by antidepressant treatment, and will have minimal side-effects.
Who is eligible to participate?
Inclusion Criteria: 1. Age 18 years or older 2. Presence of excessive sweating by self-report 3. Within 2 months of initiation of an antidepressant or increase in the dose, there was a clear and substantial increase in sweating not explained by undue external warmth, exercise, or other reason. If treatment with the antidepressant was interrupted, did not persist for more than 6 weeks during that interruption 4. Treatment with the antidepressant is deemed to be clinically necessary due to substantial benefit from the antidepressant that is causing the excessive sweating, and failure to respond to or tolerate an alternative antidepressant 5. Decrease in dose of the antidepressant is either not clinically viable due to the benefit obtained at the current dose OR decrease in dose of the antidepressant has been tried but was not effective. 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 9. Use of effective contraception (e.g., sterilization, oral contraceptives, condom with spermicide, etc) Exclusion Criteria: 1. Presence of another known disease that could potentially cause excessive sweating 2. Failure to respond in the past to anticholinergic treatment for excessive sweating 3. Previous allergic reaction to glycopyrrolate 4. Narrow angle glaucoma 5. Significant cardiac disease including cardiac or heart block 6. Patients with known hot-flashes or who are menopausal 7. History of urinary retention 8. History of seizures 9. Pregnancy or breastfeeding 10. Other significant medical illness or laboratory abnormalities that, in the judgment of the PI, would increase risk to the patient
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Glycopyrrolateglycopyrrolate 2 to 6mg/day
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
glycopyrrolateglycopyrrolate 2 to 6 mg/day
Start Date: April 2012
Completed Date: June 2016
Phase: Phase 1
Primary Outcome: Clinical Global Impression- Improvement scores
Secondary Outcome: change in mean of patient rated severity of sweating for each week, and change in mean skin conductance for each week
Study sponsors, principal investigator, and references
Principal Investigator: Rajnish Mago, MD
Lead Sponsor: Thomas Jefferson University