Clinical trial NCT02365870: Anxiety in Parkinson's: Use of Quantitative Methods to Guide Rational Treatment
Official title: Anxiety in Parkinson's: Use of Quantitative Methods to Guide Rational Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anxiety Disorders
Parkinson Disease
Keywords: Anxiety Disorders
Parkinson Disease
rotigotine
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2015-02-19
Enrollment: 4
Sex: ALL
Minimum age (years): 21
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in Anxiety Symptom Severity as Assessed by the Hamilton Anxiety Rating Scale
timeFrame: Baseline, weeks 2, 4 and 8
Secondary outcomes:
measure: Change in Depression Symptom Severity as Assessed by the 17-item Hamilton Depression Rating Scale
timeFrame: Baseline, weeks 2, 4 and 8
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Gregory Pontone, MD
role: PRINCIPAL_INVESTIGATOR
References: