Anxiety Disorders, Parkinson Disease
Conditions
Keywords
Anxiety Disorders, Parkinson Disease, rotigotine
Brief summary
This study will evaluate the effectiveness of the rotigotine transdermal patch in reducing anxiety in people with Parkinson's disease.
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.
Interventions
Participants will receive the dopamine agonist rotigotine in the form of a transdermal patch to be worn daily
DRUGplacebo
Participants will receive a placebo transdermal patch to be worn daily
Sponsors
National Institute on Aging (NIA)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety Symptom Severity as Assessed by the Hamilton Anxiety Rating Scale | Baseline, weeks 2, 4 and 8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression Symptom Severity as Assessed by the 17-item Hamilton Depression Rating Scale | Baseline, weeks 2, 4 and 8 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rotigotine rotigotine transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks
rotigotine transdermal patch: Participants will receive the dopamine agonist rotigotine in the form of a transdermal patch to be worn daily | 1 |
| Placebo placebo transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks
placebo: Participants will receive a placebo transdermal patch to be worn daily | 3 |
| Total | 4 |
Baseline characteristics
| Characteristic | Rotigotine | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 0 | 68.3 years STANDARD_DEVIATION 6.4 | 62.75 years STANDARD_DEVIATION 12.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Participants with Depression at baseline | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 3 |
| other Total, other adverse events | 0 / 1 | 1 / 3 |
| serious Total, serious adverse events | 0 / 1 | 0 / 3 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rotigotine | Change in Anxiety Symptom Severity as Assessed by the Hamilton Anxiety Rating Scale | Baseline | 23 score on a scale | Standard Deviation 0 |
| Rotigotine | Change in Anxiety Symptom Severity as Assessed by the Hamilton Anxiety Rating Scale | Week 2 | 20 score on a scale | Standard Deviation 0 |
| Rotigotine | Change in Anxiety Symptom Severity as Assessed by the Hamilton Anxiety Rating Scale | Week 4 | 5 score on a scale | Standard Deviation 0 |
| Rotigotine | Change in Anxiety Symptom Severity as Assessed by the Hamilton Anxiety Rating Scale | Week 8 | 9 score on a scale | Standard Deviation 0 |
| Placebo | Change in Anxiety Symptom Severity as Assessed by the Hamilton Anxiety Rating Scale | Week 8 | 14.7 score on a scale | Standard Deviation 11.9 |
| Placebo | Change in Anxiety Symptom Severity as Assessed by the Hamilton Anxiety Rating Scale | Baseline | 20.7 score on a scale | Standard Deviation 5.1 |
| Placebo | Change in Anxiety Symptom Severity as Assessed by the Hamilton Anxiety Rating Scale | Week 4 | 18.3 score on a scale | Standard Deviation 13.6 |
| Placebo | Change in Anxiety Symptom Severity as Assessed by the Hamilton Anxiety Rating Scale | Week 2 | 13.7 score on a scale | Standard Deviation 6.4 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rotigotine | Change in Depression Symptom Severity as Assessed by the 17-item Hamilton Depression Rating Scale | Baseline | 10 score on a scale | Standard Deviation 0 |
| Rotigotine | Change in Depression Symptom Severity as Assessed by the 17-item Hamilton Depression Rating Scale | Week 2 | 10 score on a scale | Standard Deviation 0 |
| Rotigotine | Change in Depression Symptom Severity as Assessed by the 17-item Hamilton Depression Rating Scale | Week 4 | 4 score on a scale | Standard Deviation 0 |
| Rotigotine | Change in Depression Symptom Severity as Assessed by the 17-item Hamilton Depression Rating Scale | Week 8 | 5 score on a scale | Standard Deviation 0 |
| Placebo | Change in Depression Symptom Severity as Assessed by the 17-item Hamilton Depression Rating Scale | Week 8 | 4.3 score on a scale | Standard Deviation 5.1 |
| Placebo | Change in Depression Symptom Severity as Assessed by the 17-item Hamilton Depression Rating Scale | Baseline | 8 score on a scale | Standard Deviation 2 |
| Placebo | Change in Depression Symptom Severity as Assessed by the 17-item Hamilton Depression Rating Scale | Week 4 | 7.3 score on a scale | Standard Deviation 7.1 |
| Placebo | Change in Depression Symptom Severity as Assessed by the 17-item Hamilton Depression Rating Scale | Week 2 | 5.3 score on a scale | Standard Deviation 1.5 |