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

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

Detailed Description
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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.

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

Conditions
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Anxiety Disorders, Parkinson Disease

Intervention / Treatment
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* Drug: rotigotine transdermal patch
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: rotigotine<br>rotigotine transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks | Drug: rotigotine transdermal patch<br>* Participants will receive the dopamine agonist rotigotine in the form of a transdermal patch to be worn daily<br>* Other names: Neupro;|
| Placebo Comparator: placebo<br>placebo transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks | Drug: placebo<br>* Participants will receive a placebo transdermal patch to be worn daily<br>* Other names: placebo control;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety Disorders, Parkinson Disease, rotigotine