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

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

Study Overview

• Status: Terminated
• Conditions: Parkinson Disease; Anxiety Disorders
• Intervention / Treatment: Drug: rotigotine transdermal patch; Drug: placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of Diagnostic and Statistical Manual of Mental Disorders (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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: placebo control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Anxiety Symptom Severity as Assessed by the Hamilton Anxiety Rating Scale	The main outcome measure for this study was change in anxiety symptom severity over the course of the study. Anxiety severity was measured using the Hamilton Anxiety Rating Scale (HARS).The HARS is a 14-item questionnaire, with each item assigned a score ranging from 0 ("not present") to 4 ("severe"). The total score of this scale ranges from 0 to 56, with scores greater than 17 indicating mild severity, scores between 18 and 24 indicating mild to moderate severity and scores greater than 25 indicating moderate to severe severity.	Baseline, weeks 2, 4 and 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Depression Symptom Severity as Assessed by the 17-item Hamilton Depression Rating Scale	The main outcome measure for this study was change in depression symptom severity over the course of the study. Depression severity was measured using the Hamilton Depression Rating Scale (HAMD). The HAMD is a 17-item questionnaire, with each item assigned a score ranging from 0 ("not present") to 4 ("severe"). The total score of this scale ranges from 0 to 68, with scores greater than 7 indicating mild depressive symptoms.	Baseline, weeks 2, 4 and 8

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Gregory Pontone, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: February 11, 2015
• First Submitted That Met QC Criteria: February 11, 2015
• First Posted (Estimate): February 19, 2015

Study Record Updates

• Last Update Posted (Actual): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 18, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Parkinson Disease; rotigotine; Anxiety Disorders
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Anxiety Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine Agonists; Dopamine Agents; Rotigotine
• Other Study ID Numbers: NA_00092051; 1K23AG044441-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO