ANXPD: Anxiety in Parkinson's: Use of Quantitative Methods to Guide Rational Treatment
Study Details
Study Description
Brief Summary
This study will evaluate the effectiveness of the rotigotine transdermal patch in reducing anxiety in people with Parkinson's disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 Design
Arms and Interventions
| 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Johns Hopkins University School of Medicine | Baltimore | Maryland | United States | 21287 |
Sponsors and Collaborators
- Johns Hopkins University
- National Institute on Aging (NIA)
Investigators
- Principal Investigator: Gregory Pontone, MD, Johns Hopkins University
Study Documents (Full-Text)
More Information
Publications
None provided.- NA_00092051
- 1K23AG044441-01A1
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Rotigotine | Placebo |
|---|---|---|
| Arm/Group Description | 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 | 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 |
| Period Title: Overall Study | ||
| STARTED | 1 | 3 |
| COMPLETED | 1 | 3 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Rotigotine | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | Total of all reporting groups |
| Overall Participants | 1 | 3 | 4 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
46
(0)
|
68.3
(6.4)
|
62.75
(12.3)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
1
100%
|
2
66.7%
|
3
75%
|
| Male |
0
0%
|
1
33.3%
|
1
25%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
1
100%
|
3
100%
|
4
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
1
100%
|
3
100%
|
4
100%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Participants with Depression at baseline (Count of Participants) | |||
| Count of Participants [Participants] |
1
100%
|
2
66.7%
|
3
75%
|
Outcome Measures
| Title | Change in Anxiety Symptom Severity as Assessed by the Hamilton Anxiety Rating Scale |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Rotigotine | Placebo |
|---|---|---|
| Arm/Group Description | 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 | 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 |
| Measure Participants | 1 | 3 |
| 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)
|
| Title | Change in Depression Symptom Severity as Assessed by the 17-item Hamilton Depression Rating Scale |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Rotigotine | Placebo |
|---|---|---|
| Arm/Group Description | 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 | 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 |
| Measure Participants | 1 | 3 |
| 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)
|
Adverse Events
| Time Frame | 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). | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Rotigotine | Placebo | ||
| Arm/Group Description | 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 | 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 | ||
All Cause Mortality |
||||
| Rotigotine | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | 0/3 (0%) | ||
Serious Adverse Events |
||||
| Rotigotine | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | 0/3 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Rotigotine | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | 1/3 (33.3%) | ||
| Cardiac disorders | ||||
| Edema | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| General disorders | ||||
| Excessive Somnolence | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
| Psychiatric disorders | ||||
| Hallucinations | 0/1 (0%) | 0 | 1/3 (33.3%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Gregory Pontone |
|---|---|
| Organization | Johns Hopkins University School of Medicine |
| Phone | (410) 502 - 0477 |
| gpontone@jhmi.edu |
- NA_00092051
- 1K23AG044441-01A1