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

Johns Hopkins University

Status and phase: Terminated; Phase 4

Conditions: Parkinson Disease; Anxiety Disorders

Treatments: Drug: rotigotine transdermal patch; Drug: placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02365870

1K23AG044441-01A1 (U.S. NIH Grant/Contract)

NA_00092051

Details and patient eligibility

About

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

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 21 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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4 participants in 2 patient groups, including a placebo group

rotigotine

Active Comparator group

Description:

rotigotine transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks

Treatment:

Drug: rotigotine transdermal patch

placebo

Placebo Comparator group

Description:

placebo transdermal patch 2mg to 6mg daily per 24 hour patch for 8 weeks

Treatment:

Drug: placebo