Excessive Sweating Caused by Antidepressants: Measurement and Treatment With Glycopyrrolate (AIDES-G)

NCT01588717 | Terminated Phase 1

• 1 other identifier: AIDES-G
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperhydrosis; Depression

Keywords

Hyperhydrosis; Excessive Sweating; Sweating; Depression; Antidepressant

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression- Improvement scores

  The main comparison will be the end-of-study mean v. the baseline mean

  9 weeks per subject

Secondary Outcomes (1)

• change in mean of patient rated severity of sweating for each week, and change in mean skin conductance for each week

  9 weeks per subject

Study Arms (1)

glycopyrrolate

EXPERIMENTAL

glycopyrrolate 2 to 6 mg/day

Drug: Glycopyrrolate

Interventions

Glycopyrrolate DRUG

glycopyrrolate 2 to 6mg/day

Also known as: Cuvposa®, Robinul®, Robinul® Forte

glycopyrrolate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Presence of excessive sweating by self-report
• 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
• 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
• 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.
• 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
• Use of effective contraception (e.g., sterilization, oral contraceptives, condom with spermicide, etc)

You may not qualify if:

• Presence of another known disease that could potentially cause excessive sweating
• Failure to respond in the past to anticholinergic treatment for excessive sweating
• Previous allergic reaction to glycopyrrolate
• Narrow angle glaucoma
• Significant cardiac disease including cardiac or heart block
• Patients with known hot-flashes or who are menopausal
• History of urinary retention
• History of seizures
• Pregnancy or breastfeeding
• Other significant medical illness or laboratory abnormalities that, in the judgment of the PI, would increase risk to the patient

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Hyperhidrosis; Depression

Interventions

Glycopyrrolate

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Rajnish Mago, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: May 1, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 25, 2016

Record last verified: 2016-08

Locations

US (1)