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

Phase 4TerminatedNCT02365870

Johns Hopkins University4 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Anxiety Disorders Parkinson Disease

Interventions

rotigotine transdermal patchDRUG

Participants will receive the dopamine agonist rotigotine in the form of a transdermal patch to be worn daily

placeboDRUG

Participants will receive a placebo transdermal patch to be worn daily

Eligibility

Sex: ALLMin age: 21 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Locations (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline, weeks 2, 4 and 8

Secondary Outcomes

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.

Time frame: Baseline, weeks 2, 4 and 8

Data from ClinicalTrials.gov

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