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Anxiety in Parkinson's: Use of Quantitative Methods to Guide Rational Treatment (ANXPD)

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ClinicalTrials.gov Identifier: NCT02365870
Recruitment Status : Recruiting
First Posted : February 19, 2015
Last Update Posted : January 8, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This study will evaluate the effectiveness of the rotigotine transdermal patch in reducing anxiety in people with Parkinson's disease.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Parkinson Disease Drug: rotigotine transdermal patch Drug: placebo Phase 4

Detailed Description:

Anxiety is a serious medical condition that worsens quality of life by negatively affecting peoples thoughts, feelings, and ability to function normally. Anxiety can affect anyone, but people with Parkinson's appear to be at a much higher risk with an estimated 40% or more suffering from anxiety. Parkinson's is a neurological disorder that causes tremor and other problems with normal movements. The disease symptoms are believed to be caused in large part by the loss of dopamine producing cells in the midbrain. Anxiety in Parkinson's may be associated with the loss of dopamine caused by the disease and therefore may respond to dopamine based treatments. This study will evaluate the effectiveness of the rotigotine transdermal patch, a dopamine replacement medication, in reducing symptoms of anxiety in people with Parkinson's disease.

Participants in this double-blind study will be randomly assigned to receive either rotigotine or a placebo patch for 8-weeks. All participants will be evaluated at the study site at baseline and weeks 2, 4, and 8. Psychiatric, cognitive, and movement assessments will be performed along with a review of anxiety symptoms. All participants will be offered continued routine psychiatric care with the study physician upon completion of the study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anxiety in Parkinson's: Use of Quantitative Methods to Guide Rational Treatment
Study Start Date : August 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Rotigotine

Arm Intervention/treatment
Active Comparator: rotigotine
rotigotine transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks
Drug: rotigotine transdermal patch
Participants will receive the dopamine agonist rotigotine in the form of a transdermal patch to be worn daily
Other Name: Neupro

Placebo Comparator: placebo
placebo transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks
Drug: placebo
Participants will receive a placebo transdermal patch to be worn daily
Other Name: placebo control




Primary Outcome Measures :
  1. Hamilton Anxiety Rating Scale [ Time Frame: Baseline, weeks 2, 4, and 8 ]
    Change in anxiety symptom severity score


Secondary Outcome Measures :
  1. 17-item Hamilton Depression Rating Scale [ Time Frame: Baseline, weeks 2, 4, and 8 ]
    Change in depression symptom severity score



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of DSM 5 Anxiety Disorder
  • Stable medical history and general health
  • On stable anti-parkinsonian therapy for 2 weeks before enrollment

Exclusion Criteria:

  • Unstable medical disease of comorbid psychiatric disease
  • Dementia
  • Subjects with less than one year duration of Parkinson's
  • Current treatment with a dopamine agonist

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02365870


Contacts
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Contact: Gregory Pontone, MD 410 502-0477 gponton1@jhmi.edu
Contact: Zoltan Mari, MD 410-502-0133 zmari1@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21287
Contact: Kate Perepezko, MSPH    410-614-1242    kperepe1@jhu.edu   
Contact: Gregory Pontone, MD    410 502-0477    gponton1@jhmi.edu   
Principal Investigator: Gregory Pontone, MD         
Sponsors and Collaborators
Johns Hopkins University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Gregory Pontone, MD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02365870     History of Changes
Other Study ID Numbers: NA_00092051
1K23AG044441-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 19, 2015    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Will determine how data will be shared once study is complete.
Keywords provided by Johns Hopkins University:
Anxiety Disorders
Parkinson Disease
rotigotine
Additional relevant MeSH terms:
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Parkinson Disease
Anxiety Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Mental Disorders
Rotigotine
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs