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Trial record 9 of 17 for:    Parkinson's disease | Recruiting | United States, Maryland | NIH

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Johns Hopkins University
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Gregory Pontone, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT02365870
First received: February 11, 2015
Last updated: August 29, 2016
Last verified: August 2016
  Purpose
This study will evaluate the effectiveness of the rotigotine transdermal patch in reducing anxiety in people with Parkinson's disease.

Condition Intervention Phase
Anxiety Disorders
Parkinson Disease
Drug: rotigotine transdermal patch
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anxiety in Parkinson's: Use of Quantitative Methods to Guide Rational Treatment

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Hamilton Anxiety Rating Scale [ Time Frame: Baseline, weeks 2, 4, and 8 ] [ Designated as safety issue: No ]
    Change in anxiety symptom severity score


Secondary Outcome Measures:
  • 17-item Hamilton Depression Rating Scale [ Time Frame: Baseline, weeks 2, 4, and 8 ] [ Designated as safety issue: Yes ]
    Change in depression symptom severity score


Estimated Enrollment: 60
Study Start Date: August 2016
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 89 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02365870

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

Locations
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
Principal Investigator: Gregory Pontone, MD Johns Hopkins University
  More Information

Responsible Party: Gregory Pontone, MD, Gregory Pontone, MD, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02365870     History of Changes
Other Study ID Numbers: K23AG044441  1K23AG044441-01A1 
Study First Received: February 11, 2015
Last Updated: August 29, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
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:
Parkinson Disease
Anxiety Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Mental Disorders
N 0437
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2016