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

NCT02365870 | Terminated Phase 4 Results

• 2 other identifiers: NA_000920511K23AG044441-01A1
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anxiety Disorders; Parkinson Disease

Keywords

Anxiety Disorders; Parkinson Disease; rotigotine

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, weeks 2, 4 and 8

Secondary Outcomes (1)

• Change in Depression Symptom Severity as Assessed by the 17-item Hamilton Depression Rating Scale

  Baseline, weeks 2, 4 and 8

Study Arms (2)

rotigotine

ACTIVE COMPARATOR

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

Drug: rotigotine transdermal patch

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

rotigotine transdermal patch DRUG

Participants will receive the dopamine agonist rotigotine in the form of a transdermal patch to be worn daily

Also known as: Neupro

rotigotine

placebo DRUG

Participants will receive a placebo transdermal patch to be worn daily

Also known as: placebo control

placebo

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unstable medical disease of comorbid psychiatric disease
• Dementia
• Subjects with less than one year duration of Parkinson's
• Current treatment with a dopamine agonist

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Parkinson Disease

Interventions

rotigotine

Condition Hierarchy (Ancestors)

Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Dr. Gregory Pontone
• Organization: Johns Hopkins University School of Medicine

gpontone@jhmi.edu

(410) 502 - 0477

Study Officials

• Gregory Pontone, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2015
• First Posted: February 19, 2015
• Study Start: August 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: March 31, 2020
• Results First Posted: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)