A Phase 4 interventional study of rotigotine transdermal patch and placebo in Anxiety Disorders and Parkinson Disease, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to participants aged 21 Years to 89 Years. Per ClinicalTrials.gov, last updated 2020-03-31.
Sponsored by Johns Hopkins University · Phase 4, Interventional, and Treatment
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.
5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.
This study's enrollment of 4 is below the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Johns Hopkins University is the lead sponsor of 1,809 studies on the registry; 314 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
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Exclusion Criteria:
rotigotine transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks
Drug: rotigotine transdermal patch
placebo transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks
Drug: placebo
Participants will receive the dopamine agonist rotigotine in the form of a transdermal patch to be worn daily
Also known as: Neupro
Participants will receive a placebo transdermal patch to be worn daily
Also known as: placebo control
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
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
| Milestone | Rotigotine | Placebo |
|---|---|---|
| Started | 1 | 3 |
| Completed | 1 | 3 |
| Not completed | 0 | 0 |
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.
| score on a scale | Rotigotine | Placebo |
|---|---|---|
| Baseline | 23 ± 0 | 20.7 ± 5.1 |
| Week 2 | 20 ± 0 | 13.7 ± 6.4 |
| Week 4 | 5 ± 0 | 18.3 ± 13.6 |
| Week 8 | 9 ± 0 | 14.7 ± 11.9 |
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.
| score on a scale | Rotigotine | Placebo |
|---|---|---|
| Baseline | 10 ± 0 | 8 ± 2 |
| Week 2 | 10 ± 0 | 5.3 ± 1.5 |
| Week 4 | 4 ± 0 | 7.3 ± 7.1 |
| Week 8 | 5 ± 0 | 4.3 ± 5.1 |
Collected over Adverse event data were collected during the course of the study. This spanned from baseline through the tapering period for the drug (up to 42 days after the final study visit).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rotigotine | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Placebo | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) |
| Event | Rotigotine | Placebo |
|---|---|---|
| Excessive SomnolenceGeneral disorders | 0/1 | 1/3 |
| HallucinationsPsychiatric disorders | 0/1 | 1/3 |
| EdemaCardiac disorders | 0/1 | 1/3 |
| Age, Continuous(years) | Rotigotine | Placebo | Total |
|---|---|---|---|
| Mean | 46 ± 0 | 68.3 ± 6.4 | 62.75 ± 12.3 |
| Sex: Female, Male(Participants) | Rotigotine | Placebo | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 0 | 1 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Rotigotine | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 1 | 3 | 4 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Rotigotine | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 1 | 3 | 4 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Participants with Depression at baseline(Participants) | Rotigotine | Placebo | Total |
|---|---|---|---|
| Count of participants | 1 | 2 | 3 |
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Studies of the drug tested here: Rotigotine